|Date & Time||28 September 2021 16:00-18:00 CEST|
This EATRIS and HESI collaboration webinar will focus on cell-based therapies from the regulatory perspective with preclinical considerations. The session will include:
- An introduction by Bill Shingleton from Cytiva (UK); CT-TRACS Committee Co-Chair.
- A talk on “Regulatory considerations for preclinical development of cell-based therapies – learnings for the future” – Tineke van den Hoorn – Medicines Evaluation Board (The Netherlands).
- A talk on “Preclinical Considerations for Cellular Therapies: A CBER/FDA Perspective” – Kate Dabirsiaghi – US FDA/CBER/OTAT (USA)
- A talk on “Case-study, nTRACK project – Utilizing nanoparticles for cell tracking; lessons learned from the regulatory process in the EU” – Marta Rayo Lunar, BSc Pharm – Asphalion (Spain).
- A live Q&A and Panel Discussion with all speakers. Participants in the audience will have the opportunity to ask questions through the webinar platform.
Registration is free and open to the public. The details will be posted on this page once available. For now, please save the date: Tuesday 28 September 2021 at 16:00-18:00 CEST (10:00-12:00 Eastern Time).
This event is co-organised by EATRIS and the HESI CT-TRACS Committee.