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Key deadlines

Conference starts:

2017-01-05

Website

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Conference Description

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.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
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