Name: Postmarketing Regulatory Considerations for Drugs
Start: 2017-05-05T09:00:00-07:00
End: 2017-05-05T16:00:00-07:00
Location: James H. Clark Center, S361

Postmarketing Regulatory Considerations for Drugs 

Center of Excellence in Regulatory Science and Innovation is a partnership between University of California San Francisco (UCSF), Stanford University and U.S. Food and Drug Administration (FDA).

UCSF-Stanford CERSI

This pilot mini-course focuses on three topics in postmarketing regulation of drugs: pharmacovigilance, manufacturing and communications.  We will discuss the concepts and approaches used to identity an adverse event (AE), FDA AE reporting requirements, and potential post-marketing requirements (PMR)/commitments (PMC).  Regulations and regulatory guidance involved in drug manufacturing will be presented and a quality system used by manufacturers will be discussed in details.  Finally, we will provide an overview of regulations and industry practices related to product-specific Communications. Students will work in groups on a case-study.
<H2 CLASS="normal">Agenda</H2>
Lecture 1. Pharmacovigilance
<OL>
<LI>
Historical Perspective, Regulatory Concepts, and Current Practices
</LI>
<LI>
Challenges in the 21st Century
</LI>
<LI>
The Future of Drug Safety/Pharmacovigilance
</LI>
</OL>
Lecture 2. The GMPs of Drug Manufacturing
<OL>
<LI>
Drug and Biologic Manufacturing
</LI>
<LI>
Quality Systems
</LI>
<LI>
Developing Regulatory Strategy
</LI>
</OL>
Lecture 3. Regulation of communication of drug information
<OL>
<LI>
Historical context for Advertising and Promotional Regulations
</LI>
<LI>
Overview of Current Landscape 
</LI>
<LI>
Product Communications and Advertising Examples
</LI>
</OL>
Case-study. Monitoring drug use for potential safety signals
<H2>Instructors</H2>
Bruce A. Donzanti, Ph.D., Senior Group Director, Global Pharmacovigilance Innovation Policy, Regulatory Affairs, Genentech/HOFFMANN-LA ROCHE
Anissa Kalinowski, MBA, Senior Director, Commercial Regulatory Affairs, Genentech/HOFFMANN-LA ROCHE
Jennifer Mercer, Executive Director, Regulatory Affairs, BioMarin Pharmaceutical Inc. (Previously at Genentech, a member of the Roche group)

Postmarketing Regulatory Considerations for Drugs

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Postmarketing Regulatory Considerations for Drugs

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