Preparation for Psychedelic-Assisted Therapy: Legal Risk Assessment and Management

This session will equip psychedelic-assisted therapy practitioners with the knowledge to effectively manage legal risks and maintain compliance in both the current and evolving legal frameworks. We will explore essential readiness strategies, including thorough due diligence, adherence to regulatory mandates, and proactive risk management approaches.
Participants will gain valuable insights into:
• The provisions of the Controlled Substances Act and its implications for psychedelic substances;
• Key takeaways from the pivotal FDA Psychopharmacologic Drugs Advisory Committee meeting and its impact on the field;
• Developing robust informed consent processes aligned with legal and ethical standards;
• Implementing risk mitigation strategies to safeguard practices and patient well-being;
• And the anticipated FDA decision (expected on August 11, 2024) on Lykos Therapeutics’ New Drug Application for MDMA-assisted therapy to treat PTSD, as well as its implications for stakeholders and practitioners going forward.