The 2nd Annual Psychedelic Therapeutics & Drug Development Conference

MAY 23–24, 2022 | WASHINGTON, DC


Psychedelic Drugs in the Post-Approval World: Important Components of Risk Evaluation and Mitigations Strategy (REMS) Programs to Protect Public Health While Ensuring Widespread Access

Following a presentation of the results from a 2021 survey of key stakeholders which elicited expert opinions on best practices and metrics to assess the safety of psychedelic drugs within the context of a REMS, as well as the most effective structure for such programs (e.g., individual vs. shared REMS programs), panelists in this session will discuss the most relevant aspects for designing appropriate REMS programs for this new class of medicines.

Judy Ashworth, MD, Vice President, Rx Strategic Services and Chief Medical Officer, Pinney Associates

Marion Coe, PhD, Director, Clinical Development and Postmarketing Surveillance, Pinney Associates

Berra Yazar-Klosinski, PhD, Chief Scientific Officer, MAPS Public Benefit Corporation

Janetta Iwanicki, MD, Chief Scientific Officer, Research and Consulting, Rocky Mountain Poison and Drug Safety, Denver Health and Hospital Authority

Sidney Schnoll, VP, Pharmaceutical Risk Management, Pinney Associates