SKC podcast

They discuss the role of the BfArM as an interface between the national and European regulatory system, the central authorisation of innovative orphan drugs as well as the benefit risk assessment for ATMPs and debate which harmonisation and changes the EU-wide Joint Clinical Assessment (JCA) and the EU Pharma Legislation might cause.

You can find Profcast #15 Drug authorisation for orphan drugs - A glimpse behind the scenes of BfArM and CHMP on Spotify and Apple Podcast (in German language only). Tune in!

Our SKC podcast series "The Profcast - rare diseases and their therapies" aims to address the special circumstances of patients with rare diseases, the associated medicine and the challenges for research, development, economics and reimbursement. For this purpose, Prof. Matthias P. Schönermark, M.D., Ph.D., managing director of SKC, speaks with patient representatives, payers, clinicians and scientists as well as industry representatives and also focuses on specific diseases. The word Profcast is a reference to professionals or professors, whom he welcomes as his guests.

The ambition behind this is to give an appropriate space to rare diseases and their treatment sine ira et studio. After all, the motto of the Rare Disease Day states it so aptly: "Rare is many". It is estimated that 4 million people in Germany and 300 million people worldwide are affected by a rare disease. In keeping with the Rare Disease Day, which traditionally takes place on the last day of February, the Profcast is published on the last day of a month.