New European Clinical Trial Regulation Conference

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

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501058LIVE?channel=mailer&camp=Webinar&AdGroup=govevents_Jan_2017_SEO
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