New European Clinical Trial Regulation webinar by Compliance4all
- Start Date:
- Thursday, 5 January, 2017
- End Date:
- Thursday, 5 January, 2017 11:30am
- Health & Nutrition
Overview: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.
Areas Covered in the Session: Overview of the EU and the EU Regulatory Structure Marketing Authorization Options in the EU and Linkage to Conducting Clinical Studies Overview of the European Union Clinical Trial Regulation 536/2014 Pertinent, Critical Articles of Regulation 536/2014 Processes and Timelines The Ethics Committee Who Will Benefit: Clinical Operations Staff Project Team Members Quality Assurance, Monitors, CRAs Regulatory Affairs Investigators & Site Study Staff Speaker Profile: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.
161 Mission Falls Lane,
Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
- 161 Mission Falls Lane, Suite 216