What is scientific advice, how is it done and what is expected from the applicant?
These relevant questions were addressed during last week’s EKFZ Academy workshop. Dr. Jens Reinhardt, a regulatory scientist at Paul-Ehrlich-Institut (PEI) and member of the Scientific Advice Working Party of the European Medicines Agency (EMA), presented the advice possibilities given by the upper regulatory agencies in Germany and the Scientific Advice Working Party at EMA.
