EU Clinical Trial Regulation Streamlines to ”Matter of One”

Conducting clinical trials in the EU will drastically change when the new Clinical Trial Regulation comes into force in 2019.  In this Global Forum podcast, Conference Chair Nick Sykes (Senior Director, Worldwide Safety & Regulatory, Pfizer UK) and Dr. Elke Stahl, Co-Chair of the Clinical Trial Facilitation Group and preclinical assessor for the Clinical Trial Unit at BfArM, discuss the impact of this Regulation and DIA EMEA’s December 2017 Clinical Trial Regulation Conference. “It’s a big step forward because the new upcoming regulation will have, I call it always ‘the matter of one’,” explains Dr. Stahl. “We only have one set of documents, one communication route, and therefore you have one contact as a sponsor.”