Understanding the European Directives & Implementing the Guidelines
Course Description
This 1-day course is designed to provide understanding of the European Clinical Trials Directives 2001/20/EC and 2005/28/EC. The state-of-the-art regarding implementation and implications in the European member states will be presented. Other topics are the latest developments regarding safety reporting and applications of the European Databases. Interactive presentations are intended to better understand the implementation of requirements and guidance documents.
Learning Objectives
- Understand the European directives 2001/20/EC and 2005/28/EC and guidance documents
- Comprehend the implementation in the EU member states
- Understand the European Regulation No 1901/2006/EC
- Know the procedures to be compliant and reach successful implementation
Programme Highlights*
Review of key areas of the directives:
- Clinical Trial Authorisation from Ethics Committees
- Clinical Trial Authorisation from Competent Authorities
- Safety reporting
- GCP inspections
- Trial Master File and archiving
- Upcoming regulations for Paediatric Use of Medicinal Products
Workshops:
- How to apply for a EUDRACT number
- Application forms for EC and Authorities in practice
- How to process SUSARs
Who should attend?
- Everyone involved in clinical research including: pharmaceutical companies, contract research organisations, investigators, site personnel, ethics committee members, etc.
- Within the pharmaceutical industry, this course is beneficial for people from clinical research, regulatory affairs and pharmacovigilance departments
(*) Due to unforeseen circumstances, the programme may change and the ECCRT reserves the right to alter the venue or to cancel the event.
Trainer: Marleen Verbeeck, PhD & Gerald Van Roey
