The newly proposed requirements for conducting clinical studies across the European Union, (EU) via the requirement of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products), will affect all sponsors of clinical studies in the EU. Knowing what changes will be implemented now will allow all sponsors the time to adjust their processes and responsibilities across the EU.
This webinar by expert speaker Robert J. Russell will discuss the newly proposed requirements for EU Clinical Trial Regulation and cover recent updates on EU-GCP associated with the EU Clinical Trial Directive 2001/20/EC.
This session addresses the important highlights of the new EU Pharmacovigilance Directive, as it relates to studies and offers helpful tips into working with the European regulators. It will provide an overview of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.