2:00pm - 2:45pm
Bernard von Langenbeck room
Panel III: Is There Only One Way to Approval? Challenges in Implementing Psychedelic Substances in the Medical Field
Moderated by: Dr. sc. hum. Henrik Jungaberle
Psilocybin and the atypical psychedelic MDMA may be the first drugs from the psychedelic class to be approved as mental health medication. The class poses numerous questions to approval authorities like the European Medicines Agency, FDA or the German BfArM. Do traditional placebo-controlled study paradigms reach their limit with psychedelics? How will REMS (risk evaluation and mitigation strategies) criteria look, and what should they look like? Has there been progress in study design in the last years? What’s the role of the emerging “big” pharma companies and what’s the position of small and medium-sized companies in the field? A unique characteristic of the psychedelic field is the presence of non-profit pharma development strategies: what do they add to challenge?
Moderation and speakers in this panel could be changed until the last minute.