This course is co-developed and given by the Belgian Competent Authorities. European legislation is one thing; the practical implementation in Belgian is something else. The programme has been revised to include the most recent developments related to the implementation of the EU Clinical Trial Regulation 536/2014.
This 1-day course has been revised to capture the most recent developments and focuses on the current and future legal requirements of performing clinical trials with medicinal products in Belgium.
The Belgian law of 7 May 2004 on experiments on humans implements the European directive 2001/20/EC is currently valid. A number of Royal Decrees and circular letters have also been published, which detail the practical implementation of the law. This training helps participants understand how the present Belgian legal rules should be applied.
A separate part of the training is dedicated to the European Clinical Trial Regulation 536/2014, which will become applicable in 2016 and which will repeal directive 2001/20/EC after a transition phase.
Information relating to steps under development for implementation in Belgium will be presented.
Course time09h00 - 17h00
Who should attend
Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel and Ethics Committee Members.
People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments within the pharmaceutical industry
- Overview of current European and Belgian Legislation concerning Clinical Trials (incl. Amendments & Safety Reporting)
- Clinical Trials and the Belgian Ethics Committees
- The European Clinical Trial Regulation 536/2014 in short
- Update on the implementation of the EU Clinical Trial Regulation 536/2014
- Current Clinical Trial Requirements by the Belgian Competent Authority
- Provide an overview of the implementation of the EU directive into Belgian law
- Detail the practical implementation, illustrated with examples
- Understand all Belgian laws related to Clinical Research
- Get an update on the latest status on the implementation of the EU Clinical Trial Regulation 536
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (2)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained