Topic of the upcoming event
The first round table in the series starting on 29th of May 2024 will deal with ATMP regulation. Specifically we will discuss the topics of:
- how existing ATMP regulation affect the treatment of diseases
- what is the current state of use of gene & cell therapies in Slovenia, the Netherlands, and Germany, the regulatory perspective
- what areas in the regulatory process need to be improved (bylaws, guidelines, clinical pathways, etc.)
- can regulation be streamlined, can safety be preserved while the process is accelerated, made cheaper?
- what is the interplay of various levels of approvals i.e. compassionate use, hospital exemption, earlier access programs, conditional marketing authorisation, accelerated assessments, medical needs programs, managed entry agreements
- regulation of clinical trials
Panelists
The panel discussion will be moderated by Gregor Cuzak, from CTGCT. The list of confiremd panelists is:
- dr Suzana Vidic, JAZMP, Slovenian medicinal and medicina products agency – regulator
- dr Damjan Osredkar, clinician from Pediatric Clinic of UMC Ljubljana
- dr Trudy Straetmans, ATMP expert from UMC Utrecht
- dr Leila Amini, Head of Regulatory Affairs & Deputy Head R&D, Berlin Center of Advanced Therapies, Charité Berlin
- dr Tanja Španić, president Europa Donna Slovenia, patient advocate
Venue
The panel discussion will take place at the National Institute of Chemistry in Ljubljana, at the Glass Penthouse “Hawaii”, from 11:00 to 12:30. The event is a free live in-person first event, with possible attendance through a video connection. The event will be in English only. It will also be recorded to be made available on the CTGCT.si website.