The Belgian Clinical Trials Laws of 2017: A Clear Vieuw on Rules

by ECCRT

Pour obtenir des informations complémentaires sur ce programme, cliquez ci-dessous :

Lien vers un site-web avec plus d'information concernant le programme :
http://www.eccrt.com/courses/belgian-clinical-trials-law-2017-clear-view-rules

Contenu et objectifs

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 hour 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 on a comprehensive way.

Complete Belgian Law



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.

Type de programme

checkboxFormations inter
checkboxFormations intra
checkboxE-learning
checkboxCoaching
checkboxConseil
checkboxSourcing
checkboxScreening

Langue(s) utilisée(s)

AanvinkenDutch
UitvinkenFrench
UitvinkenEnglish

Public cible et prérequis

Everyone involved in clinical research, including: Pharmaceutical companies, Contract Research Organisations (CROs), Investigators, Site Personnel.

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.

Everyone 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.

Prior knowledge of the Belgian Clinical Research law dated 7th May 2004 is required. Obtain this complementary knowledge with our eLearning course ‘Local Clinical Trial Legislation in Belgium’.

Register to both courses at once and get a € 100 discount (contact us at info@eccrt.com for more details).

After the webinar questions can be posted on the ECCRT Virtual Campus Discussion Forum.

Durée et prix

Durée pour la formation inter
  • 2.5 heures

Prix (Tous les prix sont hors TVA, sauf mention contraire)
Formations inter :
» Prix total pour la formation inter : € 115
» Prix indicatif par participant et par jour : € 322