Postmarketing Regulatory Considerations for Drugs

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.

Agenda

Lecture 1. Pharmacovigilance

1. Historical Perspective, Regulatory Concepts, and Current Practices

2. Challenges in the 21st Century

3. The Future of Drug Safety/Pharmacovigilance

Lecture 2. The GMPs of Drug Manufacturing

1. Drug and Biologic Manufacturing

2. Quality Systems

3. Developing Regulatory Strategy

Lecture 3. Regulation of communication of drug information

1. Historical context for Advertising and Promotional Regulations

2. Overview of Current Landscape

3. Product Communications and Advertising Examples

Case-study. Monitoring drug use for potential safety signals

Instructors

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)