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Optimising Collaboration Between EMA and FDA for Your Development Activities
Session Chair(s)
Colin Wheeler
Vice President, Regulatory Sciences
ProPharma Group, United Kingdom
Tom Oakley
ProPharma Group, United Kingdom
In this session the presenters will discuss the growing areas of collaboration between EMA and FDA. Historically the two agencies have cooperated in a number of areas, including offering parallel scientific advice to drug developers, and have collaborated on good clinical practice (GCP) inspections, quality by design and simplifying administrative barriers to improve cross-agency communication. This session will explore some of the successes of this collaboration and the direction where future collaboration may go.