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.
Presenters
Kimberly I. Chew, Attorney, Husch Blackwell
Kevin Lanzo, President, Pharmaka Clinical Consulting LLC
Karen Luong, Partner, Husch Blackwell
Natasha V. Sumner, Attorney, Husch Blackwell
Who Should Attend
Mental health professionals including psychiatrists, psychologists, therapists, and counselors interested in integrating psychedelic therapies into their practice and wanting to understand the legalities and risks involved; lawyers and legal consultants specializing in healthcare law; healthcare administrators; research scientists; risk managers; compliance officers; and investors and entrepreneurs exploring the business and legal implications.
Continuing Education Credit
This program is pending approval for California, Colorado, Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, Tennessee, Texas, and Wisconsin continuing legal education credit.