Why Working Parties within BeCRO?
BeCRO’s main objective is to serve the interest of its members either by being a leading voice toward national instances, or through supporting knowledge or experience sharing, or by providing specific added value for the daily operational delivery of its members.
A way to achieve this is via working groups at the national level for Belgian specific matters or for European Matters, by joining forces with working parties well established in EUCROF, the European umbrella of which BeCRO is a member.
What is the added value for participants?
Joining a Working Party is offered to our members only. Participating contributes to increase the knowledge, competence/expertise and skills, to influence future regulations and gain visibility through interactions with all stakeholders including (Bio) Pharma / devices or Regulatory Agencies… As an example, the European Pediatrics or Late Phase Working Groups are systematically invited to EMA working sessions.
Which domains are tackled by Working parties?
At the European level: The Clinical Trial Regulation, Devices, Early Phase, Innovative Medicine, Late Phase, New Technologies, Pediatrics, Pharmacovigilance.
At the Belgian level: Patient Centricity and a newcomer eTMF
- Belgian Patient centricity Working Party: BeCRO has set up and coordinates, with the cabinet of Maggie De Block, FAMHP, FlandersBio, BioWin, Lifetech Brussels, BRAS and several top Pharma companies, a lobbying group on “Virtual Clinical trials and Direct to Patient Shipments”. This working group will announce regular updates in due time.
- eTMF: the objective is to understand the recent regulatory requirements and guidances, identify most common and risky danger zones, draft specific technical / system requirements most optimal to a high quality delivery, impartial review of solutions.
- GDPR Working Group: There is a lot of confusion on the impact of the GDPR and the role of the DPO function within the CRO industry. BeCRO is pleased to have a Working Group around GDPR and to share best practice on how to be compliant in Belgium (and beyond).
Goals of the Working Group:
- Sharing best practices
- Sharing Templates (e.g. contracts, Job Description DPO etc.).
- Develop a checklist of items that would need to be verified to assess compliance.
- Centralising Q&A
- Organising a practical workshop