Description
The development of psychedelic therapies in Europe must operate within the established regulatory framework for medicinal products, with centralised marketing authorisation via the European Medicines Agency as the primary route. However, existing regulatory structures were not designed for treatments that combine psychoactive compounds with structured psychotherapeutic interventions, creating challenges related to an unbiased trial design including dosing regimens, control-arms, blinding, risk management, and the integration of pharmacological and psychological components. A systematic examination of how these frameworks are interpreted and applied to psychedelic therapies is therefore required.
This PhD project adopts an integrated mixed-methods approach to analyse the global regulatory environment for psychedelic therapies, focusing on regulatory opportunities, barriers, and adaptive practices relevant to psychedelic treatments. The project combines qualitative and quantitative analysis of regulatory and policy documents with comparative case studies of medicinal products sharing key characteristics with psychedelic therapies. In addition, expert interviews with stakeholders will be conducted to capture experiential knowledge and contextualise formal regulatory requirements. Early access programmes will be examined to assess how regulatory flexibility is implemented in practice and how this influences development pathways and patient access.
Location
Copenhagen Centre for Regulatory Science and Real-world studies, Department of pharmacy, Faculty of Health and Medical Science, University of Copenhagen (Copenhagen, Denmark)
Supervisors
Christine E Hallgreen (PhD), is an Associate Professor at Department of Pharmacy, University of Copenhagen and Director of Copenhagen Centre for Regulatory Science and Real-world Studies
Prof. Nikolai C Brun (MD, PhD), is Professor of Regulatory Science, at Department of Pharmacy, University of Copenhagen
Lourdes Cantarero Arevalo (PhD), is an Associate Professor at Department of Pharmacy, University of Copenhagen. She is also Head of the WHO Collaborating Centre on the Patient Perspective in Medicine Use
Secondments
Institute: University of Groningen (Groningen, The Netherlands)
Supervisors: Prof. Brigit Toebes
Purpose: To situate regulatory processes within the wider social and legal context, and to explore how societal expectations and legal norms interact with, and potentially shape, regulatory decision-making for psychedelic therapies.
Institute: University Medical Center Groningen (Groningen, The Netherlands)
Supervisors: Prof. Robert Schoevers
Purpose: To situate regulatory processes within a clinical context. The UMCG will also serve as a homebase for a period with regular European Medicine Agency (EMA) interactions in Amsterdam.
Institute (subject to confirmation): Avextra Pharma, GB (Berlin, Germany)
Supervisors: Dr. Andres Lopez
Purpose: To learn from regulatory experience in the medical cannabis field and to examine how these strategies, challenges, and solutions may translate to the development and regulation of psychedelic therapies.
General eligibility criteria
- The position is open to candidates of any nationality (European and non-European) who fulfil the requirements set for the Doctoral Candidates (DCs) funded by Marie Skłodowska-Curie actions.
- Applicants must hold a Master’s degree in a relevant academic field, allowing enrolment in a PhD program at the hiring beneficiary.
- Applicants must not previously have been awarded a PhD degree.
- Applicants must not have resided or carried out their main activity (work, studies, etc.) in the country in which the DC project for which they are applying is based for more than 12 months in the 3 years prior to recruitment. This excludes short stays such as holidays, compulsory national service or time spent as part of a procedure for obtaining refugee status under the Geneva Convention.
- Applicants must be willing to undertake secondments at another institute of the network during the DC project, including at institutes in other countries.
- Applicants must be able to demonstrate their ability to understand and express themselves in both written and spoken English at a level that is sufficiently high to fully benefit from the network training (C1/C2 level).
- Applicants are expected to be motivated to work in the field of psychedelic therapy.
- Applicants are expected to work independently, well-structured and collaboratively in a multidisciplinary consortium.
Additional eligibility criteria
Master’s degree within health and medical sciences, pharmaceutical sciences or social sciences.
Knowledge about medicinal product regulation.
Experience with document analysis and/or interviews.