[HMCRS] Discover the Fundamentals of U.S. Pharmaceutical Regulation

<P>Join us for U.S. Pharmaceutical Regulation 101, a clear and engaging overview of how the FDA regulates drugs, presented by a team from Morrison Foerster. Learn about the FDA's role, how new drugs enter the market, and the key laws governing drug safety and effectiveness. Through real-world examples, we’ll explore market pathways and the FDA’s post-approval enforcement tools.</P> <P>Perfect for newcomers or those seeking to refresh their knowledge of drug regulation - don’t miss this opportunity to deepen your understanding of this critical field!</P> <P><B>Lunch will be provided!</P></B> <P>About the Harvard-MIT Center for Regulatory Science - Harvard, MIT, and the FDA have partnered to create a center focused on innovative approaches for the development and evaluation of medical products. Working across academia, industry, and government institutions, the Center promotes regulatory science through research and education programs, uniting stakeholders under a common mission: promoting optimal patient health outcomes through biomedical innovation and the availability of safe and effective diagnostics and treatments.</P> <P>Definition of regulatory science - Regulatory science is defined by the FDA as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” We take a broad interpretation of this definition to include work across the spectrum from drug discovery to market availability of products in the US and globally. This includes all aspects of the interlinked procedures used to invent a new drug or device, test it in clinical trials, and get it into the hands of patients and physicians.</P> <P>If you have any logistical questions, you can email us at hits_regsci@hms.harvard.edu.</P>

When 12:00 pm - 1:30 pm on 29 January 2025
Building Warren Alpert Building 236 Conference Room, Harvard Medical School, 200 Longwood Avenue Boston, MA 02115
Contact Name HMCRS