The Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014) 2017 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
The Navigating the New European Clinical Trial Regulation (EUCT Regulation 536-2014) 2017 is intended for:
- Project Team Members
- Clinical Operations Staff
- Regulatory Affairs
- Quality Assurance, Monitors, CRAs
- Clinical Trial Supply
- Investigators & Site Study Staff
- CROs, Consultants, Insurers
