Découvrez ici les présentations données au cours des workshops et symposiums de l’AFMPS.
Séance d’information pour les vétérinaires sur l'arrêté royal modifié du 21 juillet 2016
- Séance d’information pour les vétérinaires sur l'arrêté royal modifié du 21 juillet 2016 (PDF - Vidéo)
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)
Symposium sur les vaccins les 10 et 12 mai 2022
- COVID-19 vaccine trials performed in Belgium and regulatory perspective (Nele Steens)
- Setting up vaccine clinical trials in a pandemic context: experience from study site (Fien De Boever)
- Perspective for the future: Vaccinopolis and bioprepardness initiative (Pierre Van Damme)
- European marketing authorization procedure in a pandemic context: challenges and learning (Christophe Focke)
- Follow up of vaccine safety and lessons learned (Jean-Michel Dogné)
- Impact of the COVID-19 pandemic on inspection activities (Karin Froidbise)
Session d'information en ligne sur la nouvelle législation européenne relative aux médicaments vétérinaires du 22 octobre 2021
Session d'information en ligne sur la nouvelle législation européenne relative aux médicaments vétérinaires, le 15 octobre 2021
- Introduction
- Soumission de la demande d'autorisation de mise sur le marché d'un médicament vétérinaire
- Procédures et évaluation d'une demande
- Procédures après l'octroi d'une autorisation de mise sur le marché
- Pharmacovigilance et publicité
- Certificats, autorisation de fabrication et de distribution
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