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Insight Conference
Speakers
Dr. med. Marion Haberkamp
Prof. Dr. med. Gerhard Gründer
Rick Doblin, Ph.D.
Neşe Devenot, PhD
Srinivas Rao, MD, PhD
Dr. sc. hum. Henrik Jungaberle
Date
10/09/2021
Time
2:00pm - 2:45pm
Location
Bernard von Langenbeck room

Event

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. 

Speakers

Medical Doctor, Internist, & Head of Section Neurology/Psychiatry/Ophthalmology

Dr. med. Marion Haberkamp

Federal Institute of Drugs and Medical Devices, Germany
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Professor of Psychiatry

Prof. Dr. med. Gerhard Gründer

Department of Molecular Neuroimaging, Central Institute of Mental Health Mannheim
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Founder and Executive Director

Rick Doblin, Ph.D.

Multidisciplinary Association for Psychedelic Studies (MAPS)
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PhD

Neşe Devenot, PhD

Medicine, Society & Culture Research Fellow at Psymposia
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Co-Founder & CSO

Srinivas Rao, MD, PhD

atai Life Sciences
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Executive Director

Dr. sc. hum. Henrik Jungaberle

MIND Foundation
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