Odette Hauke

Company: Independent

Job title: Regulatory Affairs Consultant

Seminars:

Navigating the Evolving FDA & EMA Guidance to Accelerate Approval of MDMA, Psilocybin & DMT-Derived Therapies 3:30 pm

Reviewing the latest regulatory research in the psychedelic field Tackling the unique regulatory hurdles of MDMA vs psilocybin vs DMT Regulatory considerations for psychedelic trials, phase 1-3Read more

day: Day Two PM

Panel Discussion: Securing Regulatory Buy-In for Precision Psychiatry: What is the Regulatory View on Targeting More Precise Patient Subtypes & How Will This Effect Drug Labels? 3:00 pm

What is the regulatory guidance on how to use biomarkers and outcome measures to identify and target specific patient populations? Do regulators believe it is feasible to develop a selective population initially to confirm the treatment’s utility? How are trial enrichment criteria going to translate in the real world and affect indication statements? What are…Read more

day: Day Two PM