This course covers the newly proposed requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation 536/2014 (for Drugs, Biologics & Combination Products). The course also covers recent updates on EU-GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.
This NEW REGULATION will affect ALL Sponsors of Clinical Studies conducted in the EU. Changes against the current EU Clinical Trial Directive 2001/20/EC are highlighted. This new regulation is expected to go into Force in the EU no earlier than May 2016. Knowing what changes will be implemented now, will allow all Sponsors time to adjust their processes and responsibilities across the EU.
Learning Objectives / Key Topics: Attendees will leave the Course clearly understanding 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. In addition, this Course has been updated to provide participants with competitive insight into:
Areas Covered in the Session:
Who Will Benefit:
Robert J. Russell For the past 9 years, Bob has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington, DC, Brussels, Belgium with exclusive affiliates across Asia and Latin America. Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS / MS degree in Chemistry.