You can find the presentations that were given at workshops and symposia at the FAMHP here.
Information session for vets on the amended Royal Decree of 21 July 2016
Webinar Info AMR KB 21_07_2016 (& VO 2019_6) - AR 21_07_2016 (& Reg 2019_6)-20231108_123052 (PDF FR - PDF NL- Video)
Information session on CTR early phase for stakeholders op 15 september 2023
- Overview of numbers in BE (and in EU) for CTR - Hans Vincke- (PDF - Video)
- Regulatory aspects of the implementation of CTR and work in CTIS updates and clarifications specific for early phase tips for a smooth validation_links updated - Anne Lenaers - (PDF - Video)
- Ethics review specifics of early phase clinical trials - ir. Sébastien Vanhiesbecq, CT College Coordinator - (PDF - Video)
- General aspects regarding non-clinical assessment of early phase clinical trials - SandrineTinton - (PDF - Video)
- Specific aspects regarding non-clinical assessment of early phase trials for vaccines - G. De Meyer- (PDF - Video)
- Specific aspects regarding non-clinical assessment of early phase trials for ATMPs - Claire Beuneu - (PDF - Video)
- Outcome of the 2022 analysis of non-clinical GNAs for FIH trials and take-home messages - Sonja Beken - (PDF - Video), template of the non-clinical assessment report (PDF)
- Specific aspects regarding clinical assessment of early phase trials for oncological drugs - Alexandru-Mihail Simon - (PDF - Video)
- Specific aspects regarding clinical assessment of early phase trials for vaccines - Inne Crèvecoeur - (PDF - Video)
- Q&A session - ( Video)
Please note that in the second presentation on regulatory aspects, the links on slide 13 relating to the CTCG guidance and template cover letter for transition trials have been updated in the pdf as new versions of these documents were published in September on the Heads of Medicines Agencies website.
Please also note that a new version of the Eudralex volume 10 CTR Q&A has been published end of September (version 6.6) with implementation of the new wording on conditions as presented on slide 17 of this presentation.
We would also like to inform you that the “Guidance to the conduct of exploratory (phase 0) trials in Belgium (version 2, January 2012)” no longer applies.
Instead, we refer you to the following European guidelines:
- For small molecules: ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
- For biotechnology-derived pharmaceuticals: ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals
- For anticancer pharmaceuticals: ICH S9 Non-clinical evaluation for anticancer pharmaceuticals
- Risk mitigation guideline from EMA
Information session on CTR for stakeholders op 10 maart 2023
- Introduction (Hugues Malonnes & Nele Steens) (PDF - video)
- Overview of numbers in Belgium (and in Europe) for CTR (Hans Vincke) (PDF - video)
- Regulatory aspects of the implementation of CTR and work in CTIS: updates and clarifications, tips for a smooth validation (Anne Lenaers) (PDF - video)
- Transformation of the clinical trial landscape at European level: state of play and future initiatives (Greet Musch) (PDF - video)
- Safety cooperation and work-sharing among Member States (Elena Prokofyeva) (PDF - video)
- CT-College: missions and achievements (Katelijne Anciaux) (PDF - video)
- How Belgian medical ethics committees review clinical trials: analysis of recurrent questions in ethics reviews of pilot CTR submissions and lessons learned (Audrey Van Scharen) (PDF - video)
- First experiences in CTR - perspective of commercial sponsor (Susan Tio) (PDF - video)
- First experiences in CTR - perspective of CRO (Tom Van Paepegem & Sara Weytjens) (PDF - video)
- First experiences in CTR – learnings from a case study (Vanessa Parrein) (PDF - video)
- Q&A session (video)
session on the new European legislation on veterinary medicines on 22 October 2021
- FR - Impact on availability of veterinary medicines
Purchasing, dispensing and prescribing - NL - Impact on availability of veterinary medicines
Purchasing, dispensing and prescribing
session on the new European veterinary medicines legislation on 15 October 2021
- Introduction
- Submission of marketing authorisation applications for veterinary medicines
- Procedures and assessment of an application
- Procedures after granting a marketing authorisation
- Pharmacovigilance and advertising
- Certificates, manufacturing and distribution authorisation