Académie royale de Médecine de Belgique

|

Vidéo et Résumé de Greet Musch


Innovative treatment in oncology : access to patients from a national competent authority point of view  (focus on medicinal products)

par Greet MUSCH, Directeur général Agence Fédérale des Médicaments et des Produits de Santé.

The activities and initiatives taken by the European Regulatory Network, including the Federal Agency for Medicinal and Health Products, to facilitate safe, but timely access to cancer patients will be addressed.

The state of play of authorised medicinal products in the domain of oncology , including the PRIME initiative ( Priority Medicines project ) will be presented as well as some specific activities related to rare cancers (orphan applications), advanced therapies (ATMP’s), paediatric oncology
(PDCO) and the new launched initiative on “ repurposing “ of drugs .

The complementary efforts performed at national level will highlight the importance of clinical trials in Belgium, with special emphasis on the domain of oncology, as well as the scientific advice process (possibly with HTA), and the compassionate use and medical need programs for unmet medical needs.

Special attention will be given on the experiences gained by involving the patient in the critical R&D processes at an early stage.

Finally some challenges and opportunities from a licensing Agency perspective will be shared as part of a broader framework related to “affordability “.