Compliance4All, Online
2017-01-05
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
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