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EVENT DATE
Jan 2017
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Webinar on Navigating the New European Clinical Trial Regulation

Overview

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/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501058LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
Twitter Follow us – https://twitter.com/compliance4all    
Facebook Like us – https://www.facebook.com/Compliance4all
LinkedIn Like us – https://www.linkedin.com/company/compliance4all

Notes:
Sponsorship Details:

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