Regulatory requirements always on the radar

“As a project manager in clinical development, I always have the interaction with the regulatory department on my radar. This allows me to identify any risks to regulatory approval early on in a project. To do that, of course, you have to know the drug approval procedures.”

This is the answer given by a ClinTriCare Project Leader when asked how she benefited from the seminar “Fundamentals of Drug Approval in Germany and the EU” held by Akademie Heidelberg, which she attended on 07 November 2012 in Frankfurt am Main. The seminar explained the differences of the drug approval procedures between Germany and Europe, the requirements for the approval documents, as well as ways of extending and amending approvals. Recent amendments to the German Medicines Act and EU regulations relevant to marketing authorization were also discussed.