EU Clinical Trial Regulation: New Requirements 2015 is a webinar that covers topics such as:
- Marketing Authorization Options in the EU and Linkage to Conducting Clinical Studies
- Overview of the EU and the EU Regulatory Structure
- Pertinent, Critical Articles of Regulation 536/2014
- Overview of the European Union Clinical Trial Regulation 536/2014
- The Ethics Committee
- Processes and Timelines
- Trial Protocol and Project Management
- Phases of a Clinical Trial
- Standard Operating Procedures
- Investigational Medicinal Product Dossier
- Good Clinical Practice (GCP)
- Clinical Trial Authorization Application
- Pharmacovigilance – New EU Requirements Overview
- Good Manufacturing Practice (GMP)
- Databases
- End of a Clinical Trial
- Regulatory Process
- European Union vs. The United States
EU Clinical Trial Regulation: New Requirements 2015 is intended for clinical research professionals, project team members and associated disciplines conducting clinical studies across the European Union.
