New DIA Forum to Align Regulatory & ClinOps Expectations

The new data transparency framework, the Medical Device and In Vitro Diagnostic Regulations, the impact of Brexit – what else is new for clinical research in Europe?  As Senior Vice President, Drug Development Services, CNS, for ICON plc in Frankfurt (Germany), Dr. Peter Schueler can share extensive knowledge on this topic; he serves on the program committee and will be a featured speaker for DIA’s first Clinical and Regulatory Operational Excellence Forum in Europe, September 2017. “The whole meeting will be based very much on dialogue between regulatory and operational people. We plan to have two people holding the opening lecture, one from the operational field and one from the regulatory field, to bridge between ‘What do regulators expect?’ and ‘What can operational people deliver?,’” Dr. Schueler explains in this Global Forum podcast. “The tension between these diverse expectations among these two groups should be sorted to a certain extent in the dialogue during the session, finding out where common ground is and where both parties can actually contribute to provide best quality data about medicines that address unmet medical needs.”