Renske ten Ham - Division of Pharmaco-epidemiology and Clinical Pharmacology, Utrecht University, The Netherlands
Since 2007 Advanced Therapy Medicinal Products (ATMPs) are specifically regulated in the EU. So far, a limited number of ATMPs have been approved in the European Union despite considerable development activity in this field. As part of the Escher platform for regulatory innovation, Lygature, together with EFPIA, EBE and Utrecht University has carried out a project researching factors associated with success and failure in the development and commercialization of ATMP products in Europe.
- Challenges encountered by commercial developers in ATMP development within Europe?
- Barriers and drivers in successful navigation of the EU Regulatory landscape