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RSNN SIG ATMP meeting
On 17 November, the RSNN Special Interest Group (SIG) ATMP will organise a meeting at Villa Jongerius in Utrecht from 09:30 to 12:45. The meeting will be followed by lunch.
The meeting will focus on recent and upcoming European regulatory developments relevant to Advanced Therapy Medicinal Products (ATMPs), including the revision of the European pharmaceutical legislation and the Biotech Act. Together, we will explore what these developments may mean in practice for the development of ATMPs.
Perspectives from industry, academia and regulators will be brought together to discuss the practical implications of these developments. The meeting will provide room to address remaining uncertainties and potential bottlenecks, and to discuss what these may mean for the ATMP field going forward.
Programme
A more detailed version of the programme will follow soon.
| 09:00 - 09:30 | Arrival and registration | Speaker |
| 09:30 - 09:35 | Welcome | Kaate Vanmolkot (CCMO) & Pauline Meij (LUMC) |
| 09:35 - 10:00 | The new pharmaceutical legislation; a perspective on the future assessment of ATMPs | Emmely de Vries (CBG-MEB) |
| 10:00 - 10:30 | From legislation to implementation, what will help ATMPs reaching European patients? | Andreas Schuil (Orchard Therapeutics) |
| 10:30 - 11:00 | TIL therapy: from phase I/II, phase III and Hospital exemption to the journey of a marketing authorization procedure. | Inge Jedema (NKI) |
| 11:00 - 11:30 | A regulatory perspective on decentralized manufacturing and platform technology Clinical trial and GMO procedures: upcoming changes | Marja van de Bovenkamp (CBG-MEB) Barbara te Riet (GGO) & Kaate Vanmolkot (CCMO) |
| 12:15 - 12:45 | Panel discussion, plenary reflection & closing | |
| 13:00 | Walk-in RSNN Annual Workshop |