Navigating the Regulatory Process for Psychedelic Medicine

Course Description

Navigating the Regulatory Process for Psychedelic Medicine is an introductory course designed for clinicians interested in learning about the history, current state, and future prospects of psychedelic medicines and therapies. With the fast-paced introduction of psychedelics into the United States healthcare system, many questions have arisen about the current policy and regulatory landscape, the changes needed to integrate these medicines into the healthcare system, and the challenges that need to be addressed.

This presentation is aimed at providing a comprehensive overview of the history and current state of regulations and policies surrounding drug development and the implications for clinicians who are interested in practising psychedelic-assisted therapy (PAT). The course will focus on the studies that continue demonstrating the efficacy of medicines such as MDMA, psilocybin, and Ketamine in treating severe mental health illnesses such as PTSD and major depression.

The target audience for this course is clinicians who work or plan to work with psychedelic-assisted therapy in research or community-based settings, and others who are interested in the process by which psychedelic-assisted therapy can become approved. The course will provide a comprehensive understanding of the regulatory process, the challenges that need to be addressed, and the coalition building and consensus-building required among healthcare professionals and governing bodies to make psychedelic-assisted therapy a reality.