Regulatory landscape and requirements for the development of (bio)pharmaceuticals

From idea to marketing authorization

Description:
This workshop focuses on the development of biologics and the regulatory requirements and processes in the EU and in Germany - from regulatory advice meetings and clinical trials to marketing authorization. Please bring along your notebook so we can include some practical exercise on how to translate guideline theory into concrete work packages.

Trained topics:
-Legislation, regulatory landscape, and relevant guidelines
-German national health authorities (PEI and BfArM) and the European Medicines Agency (EMA), EMA committees and working parties
-Scientific advice meetings with regulatory authorities
-Non-clinical development
-Process development and GMP manufacturing
-Clinical trial application according to regulation (EU) No 536/2014
-Clinical development - from FIH to phase III
-Marketing authorization
-Other regulated and non-regulated procedures (e.g. individual treatments (“Heilversuch”), non-interventional studies, compassionate use, off label use

The Trainer:
Dr. Tina Schäfer is a consultant for biopharmaceutical drug development. She studied Biology at the University of Würzburg and graduated from GSLS in 2011. She has experience in biopharmaceutical drug development and is one of the scientific co-founders of CatalYm. In addition, Tina was working as a quality and nonclinical assessor for the German national health authority Paul-Ehrlich-Insitut.

To attend, please register here.

Note: Registration of GSLS doctoral researchers has priority to non-GSLS participants. Non-GSLS participants pay a service and workshop fee of EUR 50 by bank transfer.