Workshop C: Navigating Evolving Regulatory Hurdles in an Era of Growing Potential for Psychedelic Drug Approvals

Time: 1:00 pm
day: Pre-Conf Day - C


As psychedelic drug assets progress into late phase clinical studies, there are some critical questions at the forefront of everybody’s minds:

  • What is the optimal amount of psychological support that is necessary from a regulatory perspective in clinical trials for psychedelics?
  • What are regulatory agencies looking for in terms of higher quality evidence or more rigorous trial design?
  • What would the regulatory framework be if the compound is found to have any hallucinogenic properties?
  • Can expected effects of psychedelics be considered adverse events?

Address all this and more with leading clinical experts navigating the journey towards psychedelic approval. Review the latest regulatory frameworks and anticipate their implications on upcoming trial designs.