CTGCT Panel Discussion #1: ATMP regulation

The CTGCT Panel Discussion is a series of events of the Centre for Technology of Gene and Cell Therapies (CTGCT) aimed at addressing the prescient topics within the Advanced Therapies Medicinal Products (ATMP) field of translational medicine. The discussions bring together three main constituencies: researchers, clinicians and patients. The goal of CTGCT is to build bridges between biomedical researchers and clinicians who ultimately apply innovative ideas to treat the unmet needs of patients.

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 confirmed 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, 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 at: https://video.sta.si/prenos/ctgct. The event will be in English only. It will also be recorded to be made available on the CTGCT.si website.