Events
BAYBIO EVENT
May 17, 2012 - Life Science Pub Night
Join your friends and colleagues at BayBio's Life Science Pub Night on May 17 at summer summer in Emeryville. Enjoy drink specials and free appetizers at the monthly event rotating throughout the Bay Area.
Join your friends and colleagues at BayBio's Life Science Pub Night on May 17 at summer summer in Emeryville. Enjoy drink specials and free appetizers at the monthly event rotating throughout the Bay Area.
May 18, 2012 - Drug Development for the Non-Scientist
Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda. Instructor: Simon J. Tulloch, MD...
Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda. Instructor: Simon J. Tulloch, MD...
Jun 12, 2012 - Executive Series: Reimbursement: The New Investment Hurdle
With a growing number of expensive therapeutics entering the market and rising pressures to contain costs, gauging reimbursement is now a crucial element senior executives must evaluate. Payers’ increased power to restrict access and contract for reduced prices—combined with the growing use of...
With a growing number of expensive therapeutics entering the market and rising pressures to contain costs, gauging reimbursement is now a crucial element senior executives must evaluate. Payers’ increased power to restrict access and contract for reduced prices—combined with the growing use of...
Jun 12, 2012 - BioFacilities Managers' Association (BFA) 2nd Quarter Meeting: Facility Security
Facility Security Life science companies operate within a complex and challenging regulatory environment with critical concerns that extend beyond perimeter security for staff and leasehold. Secure areas within the facility such as labs, controlled substances and radioactive material storage, IP, or other highly sensitive...
Facility Security Life science companies operate within a complex and challenging regulatory environment with critical concerns that extend beyond perimeter security for staff and leasehold. Secure areas within the facility such as labs, controlled substances and radioactive material storage, IP, or other highly sensitive...
Jul 11, 2012 - Entrepreneur and Investor Roundtables 
The Entrepreneur and Investor Roundtables is a unique event designed to act as a catalyst for burgeoning entrepreneurs, and is well known for its iconic 'speed-dating' format. The Roundtables facilitate introductions, dialogue and connections between life science entrepreneurs and investors. This event...
The Entrepreneur and Investor Roundtables is a unique event designed to act as a catalyst for burgeoning entrepreneurs, and is well known for its iconic 'speed-dating' format. The Roundtables facilitate introductions, dialogue and connections between life science entrepreneurs and investors. This event...
Jul 12, 2012 - Jul 13, 2012 - BioBasics: Biotech for the Non-Scientist
Please save the date for the next BioBasics Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda....
Please save the date for the next BioBasics Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda....
Jul 25, 2012 - Jul 26, 2012 - BioMentorz: Secret Sauce of Deal Making
BioMentorz | Secret Sauce of Deal Making is a two-day skill honing course designed to provide participants with the “real world” tools necessary to achieve deal making success. Sharpen your BD skills and go to a higher level of confidence in you ability to nail the appropriate deal for your company. Any stakeholder...
BioMentorz | Secret Sauce of Deal Making is a two-day skill honing course designed to provide participants with the “real world” tools necessary to achieve deal making success. Sharpen your BD skills and go to a higher level of confidence in you ability to nail the appropriate deal for your company. Any stakeholder...
Nov 1, 2012 - BayBio Pantheon Ceremony 2012 Presenting DiNA Awards
Each year BayBio recognizes achievement and honors excellence in the life sciences industry in Northern California, as it brings together Northern California’s life sciences industry leaders. The Pantheon Awards Ceremony is a celebration of the contributions and achievements of the Bay Area, a moment to pause and re flect...
Each year BayBio recognizes achievement and honors excellence in the life sciences industry in Northern California, as it brings together Northern California’s life sciences industry leaders. The Pantheon Awards Ceremony is a celebration of the contributions and achievements of the Bay Area, a moment to pause and re flect...
Nov 15, 2012 - Nov 16, 2012 - BioBasics: Biotech for the Non-Scientist
Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda. Instructor: Karin Lucas, Ph.D....
Learn the basics of biotechnology by skilled and experienced industry scientists. Join other non-science professionals and gain a thorough understanding of the science, technology and terminology which form the foundation of the biotechnology industry. Click here for the class agenda. Instructor: Karin Lucas, Ph.D....
Dec 4, 2012 - Novo Nordisk Partnering Day
Novo Nordisk Partnering for innovation in protein-based therapeutics and technologies Novo Nordisk is a world leader in diabetes care and we have a leading position within haemostasis management, growth hormone therapy, and hormone replacement therapy. We have refined our protein competencies since 1923,...
Novo Nordisk Partnering for innovation in protein-based therapeutics and technologies Novo Nordisk is a world leader in diabetes care and we have a leading position within haemostasis management, growth hormone therapy, and hormone replacement therapy. We have refined our protein competencies since 1923,...
BAYBIO ADVANTAGE (DEDICATED PRICING FOR BAYBIO MEMBERS)
May 17, 2012 - China: Integrated IND-Enabling Support with a Sole Source Provider
You will learn the intricacies of outsourcing development programs to China, what key considerations to keep in mind, and how best to manage this process. Accessing this knowledge will allow you to make the strategic, coherent decisions that will add value and a competitive advantage to your company. Registration for...
You will learn the intricacies of outsourcing development programs to China, what key considerations to keep in mind, and how best to manage this process. Accessing this knowledge will allow you to make the strategic, coherent decisions that will add value and a competitive advantage to your company. Registration for...
May 24, 2012 - Personalized Medicine 5.0 - The Role of Epigenetics
Personalized medicine uses genomic variation to develop new diagnostic tests and treatments and to identify the sub-groups of patients for whom they will work best. Personalized medicine can also help determine which individuals are more prone to developing some diseases and, ideally, help with the selection of lifestyle...
Personalized medicine uses genomic variation to develop new diagnostic tests and treatments and to identify the sub-groups of patients for whom they will work best. Personalized medicine can also help determine which individuals are more prone to developing some diseases and, ideally, help with the selection of lifestyle...
May 30, 2012 - Jun 1, 2012 - MDMA 17th Annual Meeting
The Medical Device Manufacturers Association (MDMA) is thevoice representing entrepreneurial, innovative medical technology companies. The 2012 MDMA Annual Meeting will provide the definitive opportunity to learn how the United States can remain the global leader in med-tech innovation, and how we can all play a role...
The Medical Device Manufacturers Association (MDMA) is thevoice representing entrepreneurial, innovative medical technology companies. The 2012 MDMA Annual Meeting will provide the definitive opportunity to learn how the United States can remain the global leader in med-tech innovation, and how we can all play a role...
Jun 4, 2012 - Jun 6, 2012 - IBC's Vaccine Production Summit
IBC’s Vaccine Production Summit June 4-6, 2012 - The Westin San Francisco Market Street- San Francisco, CA Download Brochure Today at: http://bit.ly/HZvbkS About: As your company advances its vaccine development efforts to serve new indications and the surging global vaccines markets, it...
IBC’s Vaccine Production Summit June 4-6, 2012 - The Westin San Francisco Market Street- San Francisco, CA Download Brochure Today at: http://bit.ly/HZvbkS About: As your company advances its vaccine development efforts to serve new indications and the surging global vaccines markets, it...
Jun 4, 2012 - Jun 6, 2012 - IBC's Single-Use Applications for Biopharmaceutical Manufacturing
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing June 4-6, 2012 - The Westin San Francisco Market Street- San Francisco, CA Download Brochure Today at: http://bit.ly/Jwe3ah About: Where are we today with Single-Use Technology? Where are we going next? How do we get there?...
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing June 4-6, 2012 - The Westin San Francisco Market Street- San Francisco, CA Download Brochure Today at: http://bit.ly/Jwe3ah About: Where are we today with Single-Use Technology? Where are we going next? How do we get there?...
Jun 5, 2012 - Jun 6, 2012 - FDLI: Introduction to Medical Device Law & Regulation: The Legal Framework for Medical Device Regulation
The Food and Drug Law Institute (FDLI), with support from BayBio, is hosting its industry standard two-day introductory medical device law course in Palo Alto, CA for the first time. Don't miss your opportunity to attend this important program that, for more than 15 years, has taught thousands to think like a seasoned medical...
The Food and Drug Law Institute (FDLI), with support from BayBio, is hosting its industry standard two-day introductory medical device law course in Palo Alto, CA for the first time. Don't miss your opportunity to attend this important program that, for more than 15 years, has taught thousands to think like a seasoned medical...
Jun 5, 2012 - SARTA | MedTech Showcase
SARTA’s Med Tech Showcase on June 5 will be the largest medical technology gathering in the Sacramento region in 2012, featuring a dynamic and renowned keynote speaker, a discussion of technology adoption featuring the region’s four leading health systems, and thought-provoking, targeted sessions on Telehealth,...
SARTA’s Med Tech Showcase on June 5 will be the largest medical technology gathering in the Sacramento region in 2012, featuring a dynamic and renowned keynote speaker, a discussion of technology adoption featuring the region’s four leading health systems, and thought-provoking, targeted sessions on Telehealth,...
Jun 6, 2012 - Jun 8, 2012 - IBC's Cell Line Development and Engineering
IBC's Cell Line Development & Engineering conference will deliver the latest applications of automated tools, 'omics technologies, analytical methods and engineering strategies to help increase understanding and improve the stability, quality and manufacturability of your cell lines. You will hear the latest case studies...
IBC's Cell Line Development & Engineering conference will deliver the latest applications of automated tools, 'omics technologies, analytical methods and engineering strategies to help increase understanding and improve the stability, quality and manufacturability of your cell lines. You will hear the latest case studies...
Jun 14, 2012 - San Jose BioCenter | "The rise of Big Pharma VC Funds: Dream coming true or total nightmare?
It seems like a new Big Pharma Venture arm appears every week or so. Is this just a new trend or are they here for good? How are these Corporate VCs different than traditional VCs? Do they have the same objectives, the same investment criteria, or the same strategies? Or are they definitely two very different things? What...
It seems like a new Big Pharma Venture arm appears every week or so. Is this just a new trend or are they here for good? How are these Corporate VCs different than traditional VCs? Do they have the same objectives, the same investment criteria, or the same strategies? Or are they definitely two very different things? What...
Jun 25, 2012 - Jun 27, 2012 - IBC's Next Generation Protein Therapeutics Summit
IBC’s Next Generation Protein Therapeutics Summit brings together four conference themes to discuss the emerging wave of proteins and biologics being explored for therapeutic potential. Novel scaffolds progressing through the clinic, new approaches to improve the functionality of proteins, creative protein engineering and...
IBC’s Next Generation Protein Therapeutics Summit brings together four conference themes to discuss the emerging wave of proteins and biologics being explored for therapeutic potential. Novel scaffolds progressing through the clinic, new approaches to improve the functionality of proteins, creative protein engineering and...
Jun 28, 2012 - BioCenter IP Workshop | Personalized medicine IP in threat - What are the possible consequences of the Prometheus case on your IP strategy?
Gary Baker, Managing Director of the Quine IP Law Group, will discuss recent court cases, which effectively narrow the scope of acceptable subject matter for patent protection. In Mayo v. Prometheus (U.S. Supreme Court, No. 10–1150, argued December 7, 2011 - decided March 20, 2012), the relationship...
Gary Baker, Managing Director of the Quine IP Law Group, will discuss recent court cases, which effectively narrow the scope of acceptable subject matter for patent protection. In Mayo v. Prometheus (U.S. Supreme Court, No. 10–1150, argued December 7, 2011 - decided March 20, 2012), the relationship...
Aug 6, 2012 - Aug 8, 2012 - IBC's Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies Summit
IBC's Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies Summit August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/I7aUdZ About: Learn about Creative Engineering and Design Strategies and Emerging Preclinical/Clinical Data...
IBC's Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies Summit August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/I7aUdZ About: Learn about Creative Engineering and Design Strategies and Emerging Preclinical/Clinical Data...
Aug 6, 2012 - Aug 8, 2012 - IBC's The Future of Rx/Dx Summit: Business and Science Tracks
IBC’s The Future of Rx/Dx Summit August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/JmmaEM About: The Only Conference on the market bringing together Rx, Dx and technology players with regulators and payers to discuss strategic models...
IBC’s The Future of Rx/Dx Summit August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/JmmaEM About: The Only Conference on the market bringing together Rx, Dx and technology players with regulators and payers to discuss strategic models...
Aug 6, 2012 - Aug 8, 2012 - IBC's Next-Generation Sequencing Applications and Translational Technologies Summit
IBC's Next-Gen Sequencing Applications & Translational Technologies August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/Jo99Ir About: Learn How Clinical and Research Applications of Next-Generation Sequencing and other Translational...
IBC's Next-Gen Sequencing Applications & Translational Technologies August 6-8, 2012 * Westin San Francisco Market Street * San Francisco, CA Download the brochure today at: http://bit.ly/Jo99Ir About: Learn How Clinical and Research Applications of Next-Generation Sequencing and other Translational...
Aug 6, 2012 - Aug 8, 2012 - IBC's Clinical Biomarkers and New Frontiers in Cancer
Find Strategies for Predicting Patient Response to Cancer Therapies and Learn about Clinical Insights Emerging from Biomarker Studies that Offer New Drug and Diagnostic Development Opportunities. Personalized cancer medicine driven by biomarkers is really starting to happen in routine oncology practice as doctors are now able to...
Find Strategies for Predicting Patient Response to Cancer Therapies and Learn about Clinical Insights Emerging from Biomarker Studies that Offer New Drug and Diagnostic Development Opportunities. Personalized cancer medicine driven by biomarkers is really starting to happen in routine oncology practice as doctors are now able to...
Oct 1, 2012 - Oct 3, 2012 - AdvaMed 2012
October 1-3, AdvaMed 2012 program tracks will feature expert panelists focused on In Vitro Diagnostics, Key Health Policies, Business Development & Finance, Compliance Best Practices, Emerging Growth Company Issues, Executive Workshops, eHealth & Health IT, Legal, Quality, Regulatory, and Reimbursement...
October 1-3, AdvaMed 2012 program tracks will feature expert panelists focused on In Vitro Diagnostics, Key Health Policies, Business Development & Finance, Compliance Best Practices, Emerging Growth Company Issues, Executive Workshops, eHealth & Health IT, Legal, Quality, Regulatory, and Reimbursement...
Oct 9, 2012 - Oct 10, 2012 - UC Berkeley BioExec Institute - Creating Value
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
Nov 7, 2012 - Nov 8, 2012 - UC Berkeley BioExec Institute - Managing Value
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
Dec 6, 2012 - Dec 7, 2012 - UC Berkeley BioExec Institute - Growing Value
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
The BioExec Institute is an internationally-renowned executive program delivered by leading industry experts for life sciences Directors and VP-level managers who are searching for the keys to managing business trade-offs within a highly regulated and competitive industry. Delivered by industry specialists who have provided unique...
COMMUNITY EVENTS
Apr 2, 2012 - May 21, 2012 - Science of Clinical Trial Design - UCSC Extension
This course reviews the science that forms the basis of effective clinical trial design. Topics include classifying and describing trial design by stage in drug and device development; reasons for clinical trials; types of trial designs; defining the hypothesis and study objectives; determining the population and sample...
This course reviews the science that forms the basis of effective clinical trial design. Topics include classifying and describing trial design by stage in drug and device development; reasons for clinical trials; types of trial designs; defining the hypothesis and study objectives; determining the population and sample...
Apr 2, 2012 - Jun 11, 2012 - Biochemistry: An Introduction - UCSC Extension
This course covers biochemistry concepts central to the biotechnology industry with an emphasis on the enzymatic and metabolic processes of living systems at the molecular level. Topics include the structure and function of biomolecules including proteins, carbohydrates, lipids and nucleic acids; enzymes and enzyme...
This course covers biochemistry concepts central to the biotechnology industry with an emphasis on the enzymatic and metabolic processes of living systems at the molecular level. Topics include the structure and function of biomolecules including proteins, carbohydrates, lipids and nucleic acids; enzymes and enzyme...
Apr 3, 2012 - Jun 30, 2012 - Clinical Research: The Study Site Perspective - UCSC Extension
The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. This course offers practical insight into the clinical research process from the viewpoint of the study site. Lectures and...
The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. This course offers practical insight into the clinical research process from the viewpoint of the study site. Lectures and...
Apr 3, 2012 - Jun 30, 2012 - Statistics - UCSC Extension
This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression. The instructor will demonstrate the use of spreadsheets...
This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression. The instructor will demonstrate the use of spreadsheets...
Apr 4, 2012 - May 23, 2012 - Regulatory Compliance for Medical Devices - UCSC Extension
Lectures, interactive discussions and case studies provide in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. Emphasis is placed on using the principles in the medical device quality system (QS) regulation and ISO 13485 as tools to take a...
Lectures, interactive discussions and case studies provide in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. Emphasis is placed on using the principles in the medical device quality system (QS) regulation and ISO 13485 as tools to take a...
Apr 4, 2012 - Jun 13, 2012 - Good Clinical Practices - UCSC Extension
History, ethics, and regulations provide a context for the responsible conduct of clinical research. The focus of this course is the timely, thorough and ethical conduct of clinical studies. Participants explore the translation of ethical principles into regulations (federal, state and local), recruitment and consent of...
History, ethics, and regulations provide a context for the responsible conduct of clinical research. The focus of this course is the timely, thorough and ethical conduct of clinical studies. Participants explore the translation of ethical principles into regulations (federal, state and local), recruitment and consent of...
Apr 4, 2012 - Jun 13, 2012 - Drug Discovery, Introducticon - UCSC Extension
Although the fundamental principles of drug discovery are well established, the tools, technologies and methods used in the discovery and development of safe and effective drugs are constantly evolving. This introductory course provides a framework for understanding the complex process of drug discovery, from target...
Although the fundamental principles of drug discovery are well established, the tools, technologies and methods used in the discovery and development of safe and effective drugs are constantly evolving. This introductory course provides a framework for understanding the complex process of drug discovery, from target...
Apr 9, 2012 - Jun 25, 2012 - Regulation of Drugs and Biologics
Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case...
Complex regulations govern the development, manufacture, and commercialization of biomedical products. This course helps participants understand the regulatory requirements, both U.S. and international, for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Through lectures, case...
Apr 10, 2012 - Jun 26, 2012 - Regulatory Submissions: Drugs and Biologics - UCSC Extension
Submissions to a regulatory agency such as the FDA involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with regulations, guidance...
Submissions to a regulatory agency such as the FDA involve more than just writing. They also encompass strategy, editing, publishing and systematic tracking of key information. Through lectures, case studies, and hands-on exercises, new and experienced regulatory professionals learn how to work with regulations, guidance...
Apr 12, 2012 - Jun 14, 2012 - Biology of Cancer - UCSC Extension
Understanding the molecular and cellular basis of cancer is essential for the development of new therapeutic strategies and diagnostic tools. This course explores the basic biology of cancer, including the key cellular processes and players, whose alteration leads to uncontrolled cell proliferation. Topics include the...
Understanding the molecular and cellular basis of cancer is essential for the development of new therapeutic strategies and diagnostic tools. This course explores the basic biology of cancer, including the key cellular processes and players, whose alteration leads to uncontrolled cell proliferation. Topics include the...
Apr 12, 2012 - Jun 28, 2012 - Statistical Analysis and Modeling for Bioinformatics and Biomedical Applications
This course presents the statistical methods most frequently used in bioinformatics and biomedical research. Topics include probability, hypothesis testing, confidence intervals, t-tests, analysis of variance, regression analysis, power and sample size, and simulations. Students perform statistical analyses using the R...
This course presents the statistical methods most frequently used in bioinformatics and biomedical research. Topics include probability, hypothesis testing, confidence intervals, t-tests, analysis of variance, regression analysis, power and sample size, and simulations. Students perform statistical analyses using the R...
Apr 19, 2012 - Jun 30, 2012 - Drug Development Process - UCSC Extension
The development of new drugs is a highly complex, lengthy and expensive process. In this course, you examine this process--from discovery to market and beyond--and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures will address drug discovery; preclinical characterization of...
The development of new drugs is a highly complex, lengthy and expensive process. In this course, you examine this process--from discovery to market and beyond--and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures will address drug discovery; preclinical characterization of...
Apr 21, 2012 - May 21, 2012 - Bioinformatics Tools, Databases and Methods - UCSC Extension
The field of bioinformatics plays a crucial role in the storage, search, and analysis of biomolecular sequence and structure data. A significant amount of data is now available over the Web, along with software tools for data search and analysis. Knowledge of these databases and tools is essential for those working with...
The field of bioinformatics plays a crucial role in the storage, search, and analysis of biomolecular sequence and structure data. A significant amount of data is now available over the Web, along with software tools for data search and analysis. Knowledge of these databases and tools is essential for those working with...
Apr 24, 2012 - May 29, 2012 - Viruses, Vaccines and Gene Therapy - UCSC Extension
The study of viruses is a dynamic field with a rich and storied history. With almost routine doses of headline-making events, their impact on our lives and health has never been so clear and present. Rather than being a comprehensive survey, this course threads together key concepts and unifying themes to reveal the...
The study of viruses is a dynamic field with a rich and storied history. With almost routine doses of headline-making events, their impact on our lives and health has never been so clear and present. Rather than being a comprehensive survey, this course threads together key concepts and unifying themes to reveal the...
Apr 27, 2012 - May 18, 2012 - Clinical Trials Site Monitoring I - UCSC Extension
This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The expectations of the FDA, the sponsor and the site are covered. Participants are exposed to the process of site selection, budgeting, initiation visits,...
This course presents the essential elements of monitoring a clinical trial and the interaction between a sponsor and one or more sites during a clinical investigation. The expectations of the FDA, the sponsor and the site are covered. Participants are exposed to the process of site selection, budgeting, initiation visits,...
May 1, 2012 - Jun 19, 2012 - Molecular Biology, Introduction - UCSC Extension
This course provides a comprehensive introduction to molecular biology for non-biologists and a review for those who want to refresh and update their knowledge of this subject. The course includes an overview of experimental methods used in molecular biology, such as recombinant DNA, PCR, gene cloning, and gene expression...
This course provides a comprehensive introduction to molecular biology for non-biologists and a review for those who want to refresh and update their knowledge of this subject. The course includes an overview of experimental methods used in molecular biology, such as recombinant DNA, PCR, gene cloning, and gene expression...
May 4, 2012 - Jun 1, 2012 - Preparing for FDA Inspections and Conducting Sponsor Audits - UCSC Extension
In the regulated medical industry, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the...
In the regulated medical industry, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the...
May 5, 2012 - May 19, 2012 - Medical Device Design and Development - UCSC Extension
Silicon Valley is a hotbed of medical device activity, for both established firms and innovative startups. This course provides insight into the entrepreneurial nature of the medical device industry, as well as a detailed look at the design and development process for new medical devices. Beginning with an overview of...
Silicon Valley is a hotbed of medical device activity, for both established firms and innovative startups. This course provides insight into the entrepreneurial nature of the medical device industry, as well as a detailed look at the design and development process for new medical devices. Beginning with an overview of...
May 16, 2012 - May 17, 2012 - Ohlone College | Quality System Regulations for Medical Devices
A two-day workshop that provides an introduction to, or a review of, the two most important quality system regulations that govern medical device design and manufacturing: the "Good Manufacturing" (GMP) regulation required by the US FDA (21CFR820) and the "ISO 13485:2003" standard required by the...
A two-day workshop that provides an introduction to, or a review of, the two most important quality system regulations that govern medical device design and manufacturing: the "Good Manufacturing" (GMP) regulation required by the US FDA (21CFR820) and the "ISO 13485:2003" standard required by the...
May 17, 2012 - Jun 26, 2012 - From the Laboratory to Leadership program
From the Laboratory to Leadership" turns science-minded managers into capable business leaders. That means you'll get the core management skills you need to fully leverage your company's human capital. In this four-day program, developed exclusively for managers in scientific fields, participants will...
From the Laboratory to Leadership" turns science-minded managers into capable business leaders. That means you'll get the core management skills you need to fully leverage your company's human capital. In this four-day program, developed exclusively for managers in scientific fields, participants will...
May 17, 2012 - May 18, 2012 - Ohlone College | PCR-RT Training
This interactive course is a two-day, introductory training that covers the Principles of Quantitative and End-Point Real-Time PCR. Users will learn the basic concepts behind Quantitative Real-Time PCR and gain hands-on experience in setting up a Real-Time PCR reaction. The course is designed to teach proper experimental...
This interactive course is a two-day, introductory training that covers the Principles of Quantitative and End-Point Real-Time PCR. Users will learn the basic concepts behind Quantitative Real-Time PCR and gain hands-on experience in setting up a Real-Time PCR reaction. The course is designed to teach proper experimental...
May 17, 2012 - Jun 28, 2012 - RA Professional's Toolbox - UCSC Extension
Throughout biomedical product development, production and commercialization, regulatory affairs professionals play critical roles in ensuring their companies' compliance with the laws and regulations. In addition to a strong working knowledge of the regulations and solid ethical grounding, strong business and...
Throughout biomedical product development, production and commercialization, regulatory affairs professionals play critical roles in ensuring their companies' compliance with the laws and regulations. In addition to a strong working knowledge of the regulations and solid ethical grounding, strong business and...
May 18, 2012 - KPMG's Life Sciences CPE Training Session
Join KPMG’s Northern California Life Sciences practice for a series of modules and panel discussions, led by leaders from KPMG’s national and regional Life Sciences practice, focusing around the technical challenges and issues facing you and your peers in the industry. During the training session, topics to be...
Join KPMG’s Northern California Life Sciences practice for a series of modules and panel discussions, led by leaders from KPMG’s national and regional Life Sciences practice, focusing around the technical challenges and issues facing you and your peers in the industry. During the training session, topics to be...
May 19, 2012 - Jun 2, 2012 - Document Preparation: Protocols, Reports, Summaries - UCSC Extension
Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are...
Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are...
May 19, 2012 - Pharmaceuticals of the Future: Problems and Solutions
We have assembled leading scientists from San Francisco Bay Area biotechnology companies who will share their experiences and challenges in transforming an idea for a novel therapeutic into a pharmaceutical that is either market ready or close to ready. You will hear speakers from Amgen, Genentech, Bayer HealthCare,...
We have assembled leading scientists from San Francisco Bay Area biotechnology companies who will share their experiences and challenges in transforming an idea for a novel therapeutic into a pharmaceutical that is either market ready or close to ready. You will hear speakers from Amgen, Genentech, Bayer HealthCare,...
May 21, 2012 - Women in Bio - SF Bay Area - Evening of Speed Networking
The evening promises to offer an exciting environment for women in the biotech industry to meet as many people as possible in a two-hour time period. This is a great way to mingle, learn fast facts and make connections with new peers in the region. WIB-San Francisco Bay Area will be hosting speed networking events...
The evening promises to offer an exciting environment for women in the biotech industry to meet as many people as possible in a two-hour time period. This is a great way to mingle, learn fast facts and make connections with new peers in the region. WIB-San Francisco Bay Area will be hosting speed networking events...
May 22, 2012 - Supplier Controls to Meet Tougher U.S. FDA Requirements
This 90-minute webinar on supplier controls will help you refine your supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. Recent FDA statements and actions indicate the...
This 90-minute webinar on supplier controls will help you refine your supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. Recent FDA statements and actions indicate the...
May 22, 2012 - Bio2Device | What "Cancer Pathways" Mean for the Biopharma Industry
Only a few years old, results from existing “cancer pathway” pilots underway at national and regional insurers are being unveiled in 2012. If these experiments in using evidence-based medicine to improve outcomes and lower costs prove successful, drug companies will have to adapt their drug development and...
Only a few years old, results from existing “cancer pathway” pilots underway at national and regional insurers are being unveiled in 2012. If these experiments in using evidence-based medicine to improve outcomes and lower costs prove successful, drug companies will have to adapt their drug development and...
May 23, 2012 - May 24, 2012 - ChinaBio Partnering Forum
ChinaBio® Partnering Forum is the premier life science partnering event in China. Held on May 23–24, 2012 in Suzhou, the event will attract biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering....
ChinaBio® Partnering Forum is the premier life science partnering event in China. Held on May 23–24, 2012 in Suzhou, the event will attract biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering....
May 23, 2012 - May 25, 2012 - Euro-Biotech Forum 2011
Windhover Conferences invites you to join its 18th Annual Euro-Biotech Forum, the best global partnering meeting with the highest concentration of THE RIGHT senior-level biopharma executives. Featuring the leading strategic minds, one-on-one meetings and presenting companies, all at the elegant Hilton...
Windhover Conferences invites you to join its 18th Annual Euro-Biotech Forum, the best global partnering meeting with the highest concentration of THE RIGHT senior-level biopharma executives. Featuring the leading strategic minds, one-on-one meetings and presenting companies, all at the elegant Hilton...
May 23, 2012 - Warning Letter - Consent Decree Software Validation
FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations...
FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations...
May 23, 2012 - Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation. Why Should You Attend:- When existing or legacy computer systems are used in FDA or equivalent...
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation. Why Should You Attend:- When existing or legacy computer systems are used in FDA or equivalent...
May 23, 2012 - Valuing Oncology Assets: Strategies in an evolving clinical and commercial landscape
The clinical and commercial landscape for oncology drugs is rapidly evolving, led by the complexities of biomarkers, companion diagnostics, and innovative delivery and distribution models. As a consequence, the value proposition for companies developing oncology assets is changing as well. How has the...
The clinical and commercial landscape for oncology drugs is rapidly evolving, led by the complexities of biomarkers, companion diagnostics, and innovative delivery and distribution models. As a consequence, the value proposition for companies developing oncology assets is changing as well. How has the...
May 23, 2012 - GlobalSubmit Lunchtime Series: IT & IS Teams
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
May 23, 2012 - Governor Brian Schweitzer and Chapter of the Montana Ambassadors Life Sciences Technology Event
Governor Brian Schweitzer & The California Chapter of the Montana Ambassadors Invite you to a "Life Sciences Technology Event" An Evening of Collaborative Thought, Leadership & Opportunities Please join us for this special event that will focus on connecting California...
Governor Brian Schweitzer & The California Chapter of the Montana Ambassadors Invite you to a "Life Sciences Technology Event" An Evening of Collaborative Thought, Leadership & Opportunities Please join us for this special event that will focus on connecting California...
May 24, 2012 - Live webinar on Preparing for HIPAA Compliance Audits: What they will ask for, how to be prepared, and how to minimize your exposures
The new random HIPAA Compliance Audit program is in full swing, and up to 150 covered entities will be audited in 2012. Nearly any health care entity may be subject to an audit; all entities need to know what kinds of information they'll need to provide and how to prevent isues that could lead to violations and...
The new random HIPAA Compliance Audit program is in full swing, and up to 150 covered entities will be audited in 2012. Nearly any health care entity may be subject to an audit; all entities need to know what kinds of information they'll need to provide and how to prevent isues that could lead to violations and...
May 24, 2012 - An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials
If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk...
If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk...
May 24, 2012 - What Keeps You Up at Night: Fraud and Abuse Compliance Webinar Series Part III
Designed to give you a concise, high-level briefing on your most worrisome fraud and abuse compliance challenges, we are pleased to announce the third webinar in our series – "How to Handle the Bad Email or Social Media Post." Using practical examples, the webinar will examine ways to handle...
Designed to give you a concise, high-level briefing on your most worrisome fraud and abuse compliance challenges, we are pleased to announce the third webinar in our series – "How to Handle the Bad Email or Social Media Post." Using practical examples, the webinar will examine ways to handle...
May 25, 2012 - Ohlone College | Scanning Electrode Microscopy (SEM) - An Introduction
A unique opportunity to learn the Variable Pressure Scanning Electron Microscope (VPSEM). The VPSEM has revolutionized the way specimens are observed. Traditionally, specimens had to be metal coated if they were non-conductive, or critically point dried if they were wet. But these two methods of sample preparation cause...
A unique opportunity to learn the Variable Pressure Scanning Electron Microscope (VPSEM). The VPSEM has revolutionized the way specimens are observed. Traditionally, specimens had to be metal coated if they were non-conductive, or critically point dried if they were wet. But these two methods of sample preparation cause...
May 29, 2012 - ABC Transporter Vesicle Assay: Comparison of Cold (LC-MS/MS) and Hot (Radiolabeled) Methods
The increasing clinical evidence of transporter-mediated drug-drug interactions has revealed the important role of drug transporters in determining pharmacokinetics, drug efficacy and safety profiles. The guidelines recently published by International Transport Consortium (ITC) and European Medicines Agency (EMA) outline...
The increasing clinical evidence of transporter-mediated drug-drug interactions has revealed the important role of drug transporters in determining pharmacokinetics, drug efficacy and safety profiles. The guidelines recently published by International Transport Consortium (ITC) and European Medicines Agency (EMA) outline...
May 29, 2012 - Bio2Device Group | An Interventional Device to prevent Heart Failure
COR Innovation's Ryan Krone, senior mechanical engineer, and Karen Havenstrite, chief scientific officer, will cover COR Innovations' solution to preventing congestive heart failure (CHF), following myocardial infarction (i.e. heart attack) with a minimally-invasive, device-based technology. Our presentation will...
COR Innovation's Ryan Krone, senior mechanical engineer, and Karen Havenstrite, chief scientific officer, will cover COR Innovations' solution to preventing congestive heart failure (CHF), following myocardial infarction (i.e. heart attack) with a minimally-invasive, device-based technology. Our presentation will...
May 30, 2012 - Jun 27, 2012 - Post-Market Regulatory Obligations for Medical Devices
Once a medical device has received regulatory approval or clearance, it is subject to continuing regulation in the form of record keeping and reporting to the FDA. Understanding and preparing for these obligations during the submission phase yields advantages in post-marketing. This course helps regulatory affairs...
Once a medical device has received regulatory approval or clearance, it is subject to continuing regulation in the form of record keeping and reporting to the FDA. Understanding and preparing for these obligations during the submission phase yields advantages in post-marketing. This course helps regulatory affairs...
May 31, 2012 - How do I Keep FDA Happy with my Contract Manufacturer
This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements. Why Should You Attend:- No matter where a...
This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements. Why Should You Attend:- No matter where a...
May 31, 2012 - Women In Science: Developments in Diagnostics
At this Women in Science event, a panel of senior leaders in the field will discuss the current state of the molecular diagnostics industry, and the additional challenge in developing companion diagnostic tests. Have you ever wondered why the brilliant diagnostic tools used in basic research are not commonly used (or...
At this Women in Science event, a panel of senior leaders in the field will discuss the current state of the molecular diagnostics industry, and the additional challenge in developing companion diagnostic tests. Have you ever wondered why the brilliant diagnostic tools used in basic research are not commonly used (or...
May 31, 2012 - VC Task Force presents: Life Sciences Investor Pitch
The Life Science Investor Pitch programs through VC Taskforce offer an opportunity for entrepreneurs seeking start up funding to pitch in front of a distinguished panel of investors. VC Taskforce and Morgan, Lewis & Bockius, LLP have partnered to bring to you a scintillating program series to bring entrepreneurs and...
The Life Science Investor Pitch programs through VC Taskforce offer an opportunity for entrepreneurs seeking start up funding to pitch in front of a distinguished panel of investors. VC Taskforce and Morgan, Lewis & Bockius, LLP have partnered to bring to you a scintillating program series to bring entrepreneurs and...
Jun 1, 2012 - Device Corrections and Removals
This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations. Why Should You Attend: When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA? ...
This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations. Why Should You Attend: When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA? ...
Jun 2, 2012 - BioPacific PartneringTM One-on-One Forum
The annual BioPacific Conference has grown to be the largest Asian American BioPharmaceutical Conference in the San Francisco Bay Area with a global reach of enthusiastic attendees representing hundred of companies and institutions. This year, we have designed a new BioPacific Partnering platform for our conference...
The annual BioPacific Conference has grown to be the largest Asian American BioPharmaceutical Conference in the San Francisco Bay Area with a global reach of enthusiastic attendees representing hundred of companies and institutions. This year, we have designed a new BioPacific Partnering platform for our conference...
Jun 2, 2012 - Jul 14, 2012 - DNA Microarrays: Principles, Applications and Data Analysis - UCSC Extension
DNA microarrays, also known as DNA or gene chips, have revolutionized the field of molecular biology. They provide the ability to quickly and efficiently analyze complex biological processes. As a result, they play a leading role in the discovery of new biopharmaceuticals. Topics include: overview of DNA...
DNA microarrays, also known as DNA or gene chips, have revolutionized the field of molecular biology. They provide the ability to quickly and efficiently analyze complex biological processes. As a result, they play a leading role in the discovery of new biopharmaceuticals. Topics include: overview of DNA...
Jun 6, 2012 - GlobalSubmit IND Web Series
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
Jun 7, 2012 - Making All Data Count: FDA Acceptance of non-US Clinical Trials
This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US...
This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US...
Jun 7, 2012 - CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests. Why Should You Attend:- All non-waived laboratories must have a QC and QA plan that meets...
This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests. Why Should You Attend:- All non-waived laboratories must have a QC and QA plan that meets...
Jun 7, 2012 - Jul 12, 2012 - Adverse Event and Medication Coding: An Introduction to MedDRA, COSTART, and WHO-Drug - UCSC Extension
Coding dictionaries, particularly MedDRA®, are becoming increasingly important in the U.S. and Europe for the electronic transmission of adverse event reporting, both in the pre- and postmarketing areas and in the coding of clinical trial data. This course provides a unique local opportunity for an introduction...
Coding dictionaries, particularly MedDRA®, are becoming increasingly important in the U.S. and Europe for the electronic transmission of adverse event reporting, both in the pre- and postmarketing areas and in the coding of clinical trial data. This course provides a unique local opportunity for an introduction...
Jun 8, 2012 - Jun 9, 2012 - Event Name: Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance - UCSC Extension
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using,...
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using,...
Jun 8, 2012 - Jun 29, 2012 - Intellectual Property Essentials for the Life Science Industry - UCSC Extension
Biotechnology, pharmaceutical, and medical device companies must acquire, exploit, and when necessary, enforce intellectual property rights to capture the value of their technology and innovations. At the same time, the intellectual property of competitors and third parties often substantially restricts the freedom to...
Biotechnology, pharmaceutical, and medical device companies must acquire, exploit, and when necessary, enforce intellectual property rights to capture the value of their technology and innovations. At the same time, the intellectual property of competitors and third parties often substantially restricts the freedom to...
Jun 11, 2012 - Jun 13, 2012 - American Course on Drug Development and Regulatory Sciences (ACDRS) | Session 6
The ACDRS is a nonprofit educational course established in 2006 by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF working with the FDA, professional societies, a network of universities, biopharmaceutical...
The ACDRS is a nonprofit educational course established in 2006 by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF working with the FDA, professional societies, a network of universities, biopharmaceutical...
Jun 11, 2012 - How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner....
This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner....
Jun 12, 2012 - FDA Warning Letter Closeout Program
This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA. Why Should You Attend:- FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new...
This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA. Why Should You Attend:- FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new...
Jun 12, 2012 - UCSF Center for BioEntrepreneurship Event: New Source of Funding
Congress passed the JOBS Act in April to facilitate capital raising by small to medium sized companies. It legalizes crowdfunding, allowing entrepreneurs to sell shares in privately held companies to the general public. With some restrictions, firms will be able to raise up to $1 million in 12 months from small time...
Congress passed the JOBS Act in April to facilitate capital raising by small to medium sized companies. It legalizes crowdfunding, allowing entrepreneurs to sell shares in privately held companies to the general public. With some restrictions, firms will be able to raise up to $1 million in 12 months from small time...
Jun 14, 2012 - American Course on Drug Development and Regulatory Sciences (ACDRS) | Examination
The ACDRS is a nonprofit educational course established in 2006 by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF working with the FDA, professional societies, a network of universities, biopharmaceutical...
The ACDRS is a nonprofit educational course established in 2006 by the Department of Biopharmaceutical Sciences, School of Pharmacy, University of California, San Francisco (UCSF) and the Center for Drug Development Science (CDDS), UCSF working with the FDA, professional societies, a network of universities, biopharmaceutical...
Jun 15, 2012 - Jun 16, 2012 - Toxicology Basics for Biotechnology - UCSC Extension
High-throughput efforts by biopharmaceutical companies focusing on the discovery and validation of new targets and identifying agents that affect them will uncover a multitude of new chemical and biological agents that have the potential for clinical benefits. However, before such agents can be tested and used widely in...
High-throughput efforts by biopharmaceutical companies focusing on the discovery and validation of new targets and identifying agents that affect them will uncover a multitude of new chemical and biological agents that have the potential for clinical benefits. However, before such agents can be tested and used widely in...
Jun 16, 2012 - Mobile Medical Applications - UCSC Extension
A growing number of health-related software applications are being developed for use on mobile platforms, including smart phones and tablet computers. This course will benefit professionals from the medical device sector who are involved in mobile medical app development and deployment.
A growing number of health-related software applications are being developed for use on mobile platforms, including smart phones and tablet computers. This course will benefit professionals from the medical device sector who are involved in mobile medical app development and deployment.
Jun 18, 2012 - Jun 21, 2012 - BIO International Convention
The 2012 BIO International Convention returns to Boston, Mass, June 18-21 at the Boston Convention & Exhibition Center.
The 2012 BIO International Convention returns to Boston, Mass, June 18-21 at the Boston Convention & Exhibition Center.
Jun 18, 2012 - NorCal BioPharmaPM Breakfast Meeting
No matter what Project Team Leader/Project Manager leadership model an organization uses, project managers are generally responsible for leading teams to align expectations and enhance effectiveness. Furthermore, they typically lead without direct line authority. In this session we will review Team Leadership with...
No matter what Project Team Leader/Project Manager leadership model an organization uses, project managers are generally responsible for leading teams to align expectations and enhance effectiveness. Furthermore, they typically lead without direct line authority. In this session we will review Team Leadership with...
Jun 19, 2012 - Aug 28, 2012 - Risk Management for Regulated Industries - UCSC Extension
This course provides an in-depth look at risk management with a focus on how it is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and interactive workshop sessions delve into the major risk management concepts and tools, including hazard analysis, fault tree...
This course provides an in-depth look at risk management with a focus on how it is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and interactive workshop sessions delve into the major risk management concepts and tools, including hazard analysis, fault tree...
Jun 19, 2012 - Sep 28, 2012 - Bioinformatics Tools, Databases and Methods Online Course - UCSC Extension
provides a practical introduction to the main public domain tools, databases and methods used in bioinformatics, including DNA and protein databases such as Genbank and PBD, software tools such as BLAST, and methods including those for aligning sequences. It emphasizes the needs of the user of bioinformatics tools and...
provides a practical introduction to the main public domain tools, databases and methods used in bioinformatics, including DNA and protein databases such as Genbank and PBD, software tools such as BLAST, and methods including those for aligning sequences. It emphasizes the needs of the user of bioinformatics tools and...
Jun 19, 2012 - Sep 28, 2012 - Statistics Online Course - UCSC Extension
This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression.
This course explores the fundamentals of statistical methods and reasoning. Topics include descriptive methods, data gathering, probability, interval estimation, significance tests, one- and two-sample problems, categorical data analysis, correlation and regression.
Jun 19, 2012 - Biotransformation of Drug Candidates by Non-CYP Metabolic Pathways Presenter
Characterization of enzymes involved in the metabolism of new drug candidates is a central part of the drug discovery and development process. Drug metabolism is traditionally divided into phase I and II, which each include different types of reactions. Phase I reactions include oxidation, reduction and hydrolysis with...
Characterization of enzymes involved in the metabolism of new drug candidates is a central part of the drug discovery and development process. Drug metabolism is traditionally divided into phase I and II, which each include different types of reactions. Phase I reactions include oxidation, reduction and hydrolysis with...
Jun 19, 2012 - The Other Nonrodent: Göttingen Minipigs in Preclinical Toxicology
Minipigs are often overlooked as a potential nonrodent species for nonclinical studies, however there is significant data supporting their suitability for them. Join Dr. Scott Boley and Ms. Lisa Craig to explore the advantages of considering Göttingen minipigs as a suitable model for a wide range of study types. All...
Minipigs are often overlooked as a potential nonrodent species for nonclinical studies, however there is significant data supporting their suitability for them. Join Dr. Scott Boley and Ms. Lisa Craig to explore the advantages of considering Göttingen minipigs as a suitable model for a wide range of study types. All...
Jun 20, 2012 - Aug 29, 2012 - Biochemistry: An Introduction - UCSC Extension
This course covers biochemistry concepts central to the biotechnology industry with an emphasis on the enzymatic and metabolic processes of living systems at the molecular level. Topics include the structure and function of biomolecules including proteins, carbohydrates, lipids and nucleic acids; enzymes and enzyme...
This course covers biochemistry concepts central to the biotechnology industry with an emphasis on the enzymatic and metabolic processes of living systems at the molecular level. Topics include the structure and function of biomolecules including proteins, carbohydrates, lipids and nucleic acids; enzymes and enzyme...
Jun 20, 2012 - Jul 25, 2012 - Clinical Project Management - UCSC Extension
This course addresses critical elements in the effective planning and management of clinical trials. Exercises and case studies illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic development plans, team and...
This course addresses critical elements in the effective planning and management of clinical trials. Exercises and case studies illustrate how to develop and manage activities, timelines and budgets; examine staffing and resource requirements; and lead and motivate effective teams. Strategic development plans, team and...
Jun 20, 2012 - GlobalSubmit Reg Affairs Teams
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
Join us for an upcoming web demonstration to discover the advantages of using GlobalSubmit. See how the FDA views electronic submissions Build your application as the FDA sees it Cut days off the time it takes to quality check bookmarks and hyperlinks Improve your communications both internally...
Jun 21, 2012 - Sep 6, 2012 - Regulatory Submissions: Devices and Diagnostics - UCSC Extension
Designed for individuals who already have a strong foundation in medical devices, this course provides a unique opportunity to gain hands-on experience working with the regulations, guidance documents, and style guides to produce portions of key medical device submissions that both comply with the requirements and are...
Designed for individuals who already have a strong foundation in medical devices, this course provides a unique opportunity to gain hands-on experience working with the regulations, guidance documents, and style guides to produce portions of key medical device submissions that both comply with the requirements and are...
Jun 21, 2012 - Jun 22, 2012 - UC Berkeley Extension | Life Science Business Development
This intensive course including two days of classroom and balance of term for individual research is designed to provide participants with an understanding of the critical role business development and licensing functions play in the commercialization of new products or technology and to the development of a successful...
This intensive course including two days of classroom and balance of term for individual research is designed to provide participants with an understanding of the critical role business development and licensing functions play in the commercialization of new products or technology and to the development of a successful...
Jun 23, 2012 - Medical/Clinical Terminology - UCSC Extension
A basic understanding of medical and clinical terminology is essential in clinical trials design and management. This interactive workshop, for individuals with no background in medical/clinical terminology or for those who would like a refresher, reviews common terms associated with medical research and development and...
A basic understanding of medical and clinical terminology is essential in clinical trials design and management. This interactive workshop, for individuals with no background in medical/clinical terminology or for those who would like a refresher, reviews common terms associated with medical research and development and...
Jun 23, 2012 - Aug 6, 2012 - Experimental Methods in Molecular Biology - UCSC Extension
This lecture-based course provides a theoretical overview of the key molecular biology techniques used in basic life science research and by the biotechnology and biopharmaceutical industry for the discovery of novel therapeutics. Topics include gene cloning, manipulation and sequencing; PCR; RNA interference; gene...
This lecture-based course provides a theoretical overview of the key molecular biology techniques used in basic life science research and by the biotechnology and biopharmaceutical industry for the discovery of novel therapeutics. Topics include gene cloning, manipulation and sequencing; PCR; RNA interference; gene...
Jun 25, 2012 - Aug 27, 2012 - Clinical Statistics for Non-Statisticians - UCSC Extension
Clinical studies succeed or fail on the strength of their statistics. This course takes a practical approach to fundamental statistical concepts essential for non-statisticians involved in clinical research. Through lectures, discussions and in-class exercises, the instructor explores clinical study designs, hypothesis...
Clinical studies succeed or fail on the strength of their statistics. This course takes a practical approach to fundamental statistical concepts essential for non-statisticians involved in clinical research. Through lectures, discussions and in-class exercises, the instructor explores clinical study designs, hypothesis...
Jun 25, 2012 - Jun 27, 2012 - Basics of Polymer Structure & Characterization
This 3-day course covers important polymer basics as well as more advanced topics. All topics are presented in a practical manner designed for those with some technical background or education. Attendees can expect to learn about polymer synthesis and characterization, engineering design and performance of polymer...
This 3-day course covers important polymer basics as well as more advanced topics. All topics are presented in a practical manner designed for those with some technical background or education. Attendees can expect to learn about polymer synthesis and characterization, engineering design and performance of polymer...
Jun 26, 2012 - Ohlone College | Introduction to Statistics for QA/QC - Basic
This one-day workshop provides an introduction to, or a review of, the most commonly used basic statistical methods and tools used in the biotech industry. The major topics covered include review of relevant regulatory requirements, basic statistical vocabulary and concepts, probability, Law of Large Numbers,...
This one-day workshop provides an introduction to, or a review of, the most commonly used basic statistical methods and tools used in the biotech industry. The major topics covered include review of relevant regulatory requirements, basic statistical vocabulary and concepts, probability, Law of Large Numbers,...
Jun 27, 2012 - FDA's new enforcement initiative - Strategic Software Validation Planning for Executives and Managers
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA. Why should you Attend:- FDA has in place several enforcement initiatives. They are certain to impact your...
This Software Validation training webinar will discuss how to approach Strategic software Validation planning so as to satisfy FDA by complying to new enforcement initiative by FDA. Why should you Attend:- FDA has in place several enforcement initiatives. They are certain to impact your...
Jun 27, 2012 - Ohlone College | Introduction to Statistics for QA/QC - Intermediate
This one-day workshop provides an introduction to, or a review of more advanced statistical concepts and on formal statistical methods and tests: t-tests, reliability calculations, tolerance limits, significance, confidence, confidence intervals, statistical “power”, and normal transformations. There will be a...
This one-day workshop provides an introduction to, or a review of more advanced statistical concepts and on formal statistical methods and tests: t-tests, reliability calculations, tolerance limits, significance, confidence, confidence intervals, statistical “power”, and normal transformations. There will be a...
Jun 28, 2012 - Ohlone College | Introduction to Statistics for QA/QC - Advanced
This one-day workshop will instruct how to perform basic statistical tests and comparisons, how to choose QC sampling plans, how to create and use SPC charts, and how to evaluate your current calibration program for effectiveness and compliance with regulatory requirements. Reliability Plotting, SPC (Statistical Process...
This one-day workshop will instruct how to perform basic statistical tests and comparisons, how to choose QC sampling plans, how to create and use SPC charts, and how to evaluate your current calibration program for effectiveness and compliance with regulatory requirements. Reliability Plotting, SPC (Statistical Process...
Jul 2, 2012 - Jul 30, 2012 - Regulatory Intelligence - UCSC Extension
This course examines the fundamentals of regulatory intelligence, including what it is, how it is conducted, and how it can be used to inform nonclinical, clinical, manufacturing, and regulatory decision making throughout the development program for a biomedical product. The instructor takes a practical look at monitoring...
This course examines the fundamentals of regulatory intelligence, including what it is, how it is conducted, and how it can be used to inform nonclinical, clinical, manufacturing, and regulatory decision making throughout the development program for a biomedical product. The instructor takes a practical look at monitoring...
Jul 7, 2012 - Jul 14, 2012 - Value-Added Quality Audits - UCSC Extension
By auditing to domestic and international quality system regulations, biomedical corporations can improve the effectiveness of their internal systems and those of their suppliers and corporate partners. This hands-on course introduces participants to fundamental auditing principles and techniques, including planning,...
By auditing to domestic and international quality system regulations, biomedical corporations can improve the effectiveness of their internal systems and those of their suppliers and corporate partners. This hands-on course introduces participants to fundamental auditing principles and techniques, including planning,...
Jul 7, 2012 - Jul 14, 2012 - Value-Added Quality Audits - UCSC Extension
By auditing to domestic and international quality system regulations, biomedical corporations can improve the effectiveness of their internal systems and those of their suppliers and corporate partners. This hands-on course introduces participants to fundamental auditing principles and techniques, including planning,...
By auditing to domestic and international quality system regulations, biomedical corporations can improve the effectiveness of their internal systems and those of their suppliers and corporate partners. This hands-on course introduces participants to fundamental auditing principles and techniques, including planning,...
Jul 9, 2012 - Jul 10, 2012 - 10th Vaccines Research and Development: All Things Considered
GTC is proud to present its 10th Annual Vaccines Discovery and Development: All Things Considered conference, to be held in San Francisco, CA on July 9-10, 2012. This conference continues a tradition of presenting valuable updates and exposure to all aspects of vaccine development, including research, manufacturing,...
GTC is proud to present its 10th Annual Vaccines Discovery and Development: All Things Considered conference, to be held in San Francisco, CA on July 9-10, 2012. This conference continues a tradition of presenting valuable updates and exposure to all aspects of vaccine development, including research, manufacturing,...
Jul 9, 2012 - Jul 10, 2012 - Influenza Research and Development
GTC is proud to present its inaugural Influenza Research and Development conference, to be held in San Francisco, CA on July 9-10, 2012. This conference will cover various aspects of basic research in influenza including virology, pathogenesis, antivirals, antibodies and vaccination. Topics such as the current threat of the H5N1...
GTC is proud to present its inaugural Influenza Research and Development conference, to be held in San Francisco, CA on July 9-10, 2012. This conference will cover various aspects of basic research in influenza including virology, pathogenesis, antivirals, antibodies and vaccination. Topics such as the current threat of the H5N1...
Jul 10, 2012 - Aug 28, 2012 - Science of Clinical Trials Design - UCSC Extension
This course addresses the science that forms the basis of effective clinical trial design. Topics include classifying and describing trial design by stage in drug and device development; reasons for clinical trials; types of trial designs; defining the hypothesis and study objectives; determining the population and sample...
This course addresses the science that forms the basis of effective clinical trial design. Topics include classifying and describing trial design by stage in drug and device development; reasons for clinical trials; types of trial designs; defining the hypothesis and study objectives; determining the population and sample...
Jul 11, 2012 - Verification of Compendial Methods According to the Revised USP Chapter <1226>
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation. Why Should You Attend:- Compendial methods such as USP and EP standards are...
This webinar on verification of compendial methods will give a good understanding of the revised USP Chapter <1226> and FDA requirements and provide recommendations and tools for effective implementation. Why Should You Attend:- Compendial methods such as USP and EP standards are...
Jul 11, 2012 - Aug 15, 2012 - Interacting with the FDA - UCSC Extension
Regulatory affairs professionals interact with the U.S. Food and Drug Administration (FDA) throughout the life cycle of a biomedical product. Lectures, case studies and roleplaying are used to explore the range of interactions that industry has with the FDA, including inspections and key meetings. Students learn how to...
Regulatory affairs professionals interact with the U.S. Food and Drug Administration (FDA) throughout the life cycle of a biomedical product. Lectures, case studies and roleplaying are used to explore the range of interactions that industry has with the FDA, including inspections and key meetings. Students learn how to...
Jul 11, 2012 - Aug 29, 2012 - Human Factors and Usability in Medical Device Development - UCSC Extension
Understanding and applying human factors is essential to ensuring product usability and user satisfaction. Consideration of human factors also helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation...
Understanding and applying human factors is essential to ensuring product usability and user satisfaction. Consideration of human factors also helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation...
Jul 11, 2012 - Aug 8, 2012 - Stem Cell Biology - UCSC Extension
California is at the forefront of stem cell research and the industry continues to offer exciting opportunities in the Bay Area. This introduction to stem cells and their applications is geared towards professionals in the pharmaceutical, biotech, medical device, and health care industries. It addresses the basic biology...
California is at the forefront of stem cell research and the industry continues to offer exciting opportunities in the Bay Area. This introduction to stem cells and their applications is geared towards professionals in the pharmaceutical, biotech, medical device, and health care industries. It addresses the basic biology...
Jul 12, 2012 - Sep 29, 2012 - Drug Development Process - UCSC Extension
The development of new drugs is a complex, lengthy, and expensive process. In this course, we examine this process--from discovery to market and beyond--and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures address drug discovery; preclinical characterization of new drug...
The development of new drugs is a complex, lengthy, and expensive process. In this course, we examine this process--from discovery to market and beyond--and see what makes the biopharmaceutical industry unique. Infused with real-world examples, lectures address drug discovery; preclinical characterization of new drug...
Jul 12, 2012 - Sep 6, 2012 - Mass Spectrometry in Drug Discovery - UCSC Extension
Mass spectrometry (MS) has experienced revolutionary advances in recent years and has become the analytical tool of choice for a variety of research areas in drug discovery and development, ranging from proteomics to drug metabolism. This course covers the principles and applications of mass spectrometry and LC/MS (liquid...
Mass spectrometry (MS) has experienced revolutionary advances in recent years and has become the analytical tool of choice for a variety of research areas in drug discovery and development, ranging from proteomics to drug metabolism. This course covers the principles and applications of mass spectrometry and LC/MS (liquid...
Jul 17, 2012 - Jul 19, 2012 - ePharma Summit West
ePharma Summit West is the best digital marketing for the life sciences event on the west coast. Like the larger east coast version, The ePharma Summit, ePharma Summit West brings together speakers from both in and out of industry to give you the latest tactics, technologies and strategies for digital marketing today....
ePharma Summit West is the best digital marketing for the life sciences event on the west coast. Like the larger east coast version, The ePharma Summit, ePharma Summit West brings together speakers from both in and out of industry to give you the latest tactics, technologies and strategies for digital marketing today....
Jul 17, 2012 - Sep 18, 2012 - Immunology, Principles - UCSC Extension
Explore the fundamental principles of immunology along with recent developments in the field and their implications for drug discovery and development, as well as disease treatment. Topics include innate, humoral and cell-mediated immunity; the clonal selection of lymphocytes; antigens, antibodies and their interactions;...
Explore the fundamental principles of immunology along with recent developments in the field and their implications for drug discovery and development, as well as disease treatment. Topics include innate, humoral and cell-mediated immunity; the clonal selection of lymphocytes; antigens, antibodies and their interactions;...
Jul 24, 2012 - Reaction Phenotyping Methods Using Recombinant Enzymes and HLM: Tips and Tricks
Reaction phenotyping studies to identify the critical pathways involved in the metabolism of drug candidates have become an essential step in the drug development process. Approaches for reaction phenotyping include incubating the test compound with recombinant enzymes (e.g. CYPs) or with human liver microsomes (HLM) and...
Reaction phenotyping studies to identify the critical pathways involved in the metabolism of drug candidates have become an essential step in the drug development process. Approaches for reaction phenotyping include incubating the test compound with recombinant enzymes (e.g. CYPs) or with human liver microsomes (HLM) and...
Jul 28, 2012 - Aug 25, 2012 - Good Manufacturing Practices - UCSC Extension
Familiarity with the Good Manufacturing Practices (GMP) regulations is a necessity for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions and case studies, participants gain an understanding of the FDA GMP and Good Laboratory Practice...
Familiarity with the Good Manufacturing Practices (GMP) regulations is a necessity for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions and case studies, participants gain an understanding of the FDA GMP and Good Laboratory Practice...
Aug 3, 2012 - Managing Immunogenicity Risk in Biopharmaceuticals
This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals. Why Should You Attend: This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of...
This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals. Why Should You Attend: This presentation begins with an overview of the biological self versus non-self mechanism resulting in the anti-drug response of...
Sep 25, 2012 - Fluorescence-based High Throughput CYP Inhibition Assays for Detecting DDI
Inhibition of P450 can result in life-threatening drug-drug interactions. Because of the safety concerns over DDI, screening of drug candidates for P450 inhibition potential is now typically carried out in the early stages of the drug development process. Fluorescence-based CYP inhibition assays, which rely on...
Inhibition of P450 can result in life-threatening drug-drug interactions. Because of the safety concerns over DDI, screening of drug candidates for P450 inhibition potential is now typically carried out in the early stages of the drug development process. Fluorescence-based CYP inhibition assays, which rely on...
Oct 23, 2012 - Oct 26, 2012 - World ADC
500+ ADC Experts, 50+ Leading Speakers: Join the World's Largest ADC Meeting Hanson Wade's World ADC is the undisputed forum for debating ADC development strategies, presenting results and meeting those involved and investing in the antibody-drug conjugate sector. That's why every serious player in...
500+ ADC Experts, 50+ Leading Speakers: Join the World's Largest ADC Meeting Hanson Wade's World ADC is the undisputed forum for debating ADC development strategies, presenting results and meeting those involved and investing in the antibody-drug conjugate sector. That's why every serious player in...
Dec 15, 2012 - Dec 19, 2012 - 2012 American Society for Cell Biology Annual Meeting
As the premier international meeting in the field of cell biology, the ASCB Annual Meeting is intended for scientists and students in academia, industry, government, and higher education. Over 100 scientific sessions and 3,000 poster presentations cover a variety of scientific areas within the discipline. With...
As the premier international meeting in the field of cell biology, the ASCB Annual Meeting is intended for scientists and students in academia, industry, government, and higher education. Over 100 scientific sessions and 3,000 poster presentations cover a variety of scientific areas within the discipline. With...
