CTO and VP Regulatory Affairs, Tigenix
Wilfried Dalemans is Chief Technical Officer and Vice President Regulatory Affairs at TiGenix, Belgium. He is responsible for the global technical operations of the company, encompassing coordination of product development in R&D and Industrialization, and overseeing the manufacturing operations in Europe and the US. He is also responsible for the worldwide regulatory activities of the company's project and product portfolio.
Before joining TiGenix, Wilfried Dalemans held several senior management positions at GSK Biologicals, Belgium, both in regulatory affairs and in research and development. Prior to joining GSK, he worked at Transgène, France, where he was responsible for the cystic fibrosis research program.
Wilfried Dalemans holds a Masters degree in Zoology from the University of Antwerpen (Belgium) and a PhD in Molecular Biology from the Universities of Hasselt and Leuven (Belgium).
- ChondroCelect: first ATMP approval in Europe ( 2MB)
The experience of developing ChondroCelect as an Advanced Therapy Medicinal Product will be described. The applicable ATMP and Sanco regulatory frameworks will be explained. Examples will be given how the technical, preclinical and clinical regulatory requirements were put into practice. This will illustrate both the challenges and the practical solutions for achieving a market authorization for this new class of innovative medicines.