The Belgian Clinical Trials Law of 2017: A Clear View on Rules – Webinar
About this course
Reasons to attend
If you are a clinical research professional, investigator, monitor or other staff active in the field of clinical research and you need to understand and apply the laws of clinical trials conducted in Belgium, this webinar is for you. In about 1.5-hours all the new rules defined by the Belgian Clinical Trials Law of 22nd of May 2017, and what this means for procedures of clinical trials in Belgium, is presented in a comprehensive way.What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Course schedule
- Live online training: 1.5h
Course Description
Belgium has taken the first preparative steps to be ready for the application of the European Clinical Trial Regulation 536/2014 by issuing a new clinical trials law. This law sets the new rules as well as paving the way for the legal basis of pilot studies in Belgium before the mandatory European Clinical Trials Regulation becomes effective. Many imperative changes are ahead, notably regarding procedures and ethics committees.This webinar is designed for professionals who need to know the new Belgian Clinical Trials law of 2017. All the elements of the Law are presented in a clear-cut way. Specifics of the involved competent authorities, of independent ethics committees, of new submission procedures and timelines, of appeal after rejection of a clinical trial, of Phase I trials and centre requirements and of possible penalties. Adaptations to the current law of 07 May 2004 will be clarified and will enable you to get a clear view on what is applicable now and what is to be done in the future. In addition, procedures of the pilot studies are presented.The information will help you to understand upcoming Royal Decrees and to avoid missing out on mandatory and specific Belgian legal aspects of clinical trials and of pilot studies conducted in Belgium.Prior knowledge of the Belgian Clinical Research law dated 7th May 2004 is required.Programme highlight
- Introduction to and Scope of the 2017 Belgian Clinical Trials Law
- Roles of the Competent Authorities FAMHP, College, Federal Authority of Health
- Ethics Committees: The New Way
- Procedures for Submissions
- Specifications of Investigators and Phase I Investigational Sites
- Requirements for Investigational and Auxiliary Products
- Impact on the Clinical Trials Law of 2004
- Pilot studies in Belgium
Learning objectives
- Acquire a clear view of all new rules of the Belgian Clinical Trials Law 2017 and understand its impact on the law of 2004
- Know the procedures to be compliant and reach successful clinical trials submissions in Belgium
- Streamline the new requirements in your clinical research activities
Who should attend
Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel who wants to acquire knowledge of the Belgian Regulatory Requirements and who needs to comply to regulatory training requirements prior to performing work in Belgium. People from clinical operations, regulatory affairs, quality assurance and pharmacovigilance departments involved in monitoring activities (on-site or medical monitoring) of investigational sites located in Belgium.
Competencies
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 (3)
- Clinical Studies Operations (GCPs or ISO 14155) (3)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Pascale Berr
Ordina
The info presented was very clear and understandable.
Barbara Szczerba
Sanne van Rooij