Are you navigating the rapidly evolving landscape of psychedelic research and clinical care? Join us for a practical overview of the key regulatory, legal, and compliance issues facing researchers, clinicians, academic medical centers (AMCs), clinical research organizations (CROs), and stakeholders.
Topics
- The current federal status of psychedelics, including Schedule I restrictions and the unique position of ketamine.
- How recent state-level reforms (Oregon, Colorado, New Mexico) are reshaping access—and the legal uncertainties that result from federal-state conflict.
- The real-world impact of recent legal developments on research, clinical use, and the operation of state legal businesses.
- Regulatory updates on ketamine, drug shortages, and compounding implications for clinical supply and telehealth.
- Regulatory and operational essentials for conducting psychedelic clinical trials, including Investigational New Drug (IND) requirements and recent FDA guidance.
- Step-by-step Drug Enforcement Administration (DEA) registration, compliance best practices, and special considerations for research and religious exemptions (with a guest DEA compliance professional).
- Risk management strategies to minimize institutional and personal liability in a complex, shifting legal environment.
Presenters
Kimberly Chew, Attorney, 麻豆十三女郎
, President and Owner, NTH Consulting, Inc.
Karen Luong, Partner, 麻豆十三女郎
Who Should Attend
Researchers, clinicians, compliance officers, CRO leaders, AMC leaders, legal counsel, and anyone involved in psychedelic research or clinical care.
Continuing Education Credit
This program is pending approval for California, Colorado, Illinois, Iowa, Minnesota, Missouri, Kansas, Nebraska, Tennessee, Texas, and Wisconsin continuing legal education credit.