Online conference. This training course is intended for both manufacturers and distributors of medical devices/ in vitro medical devices and will address various questions/issues under the MDR/IVDR.

Online meeting During this session, an overview will be provided of both the overarching European GMO legislation as well as the GMO regulatory framework and procedures in Belgium and how this impacts the Clinical Trial Application process for gene therapy clinical trials in Belgium.

Free online session. In June 2021, Noël Wathion retired as Deputy Executive Director EMA. Over the past two years, he has been able to fully utilize his expertise and management skills to master the consequences of the Covid-19 storm. On November 23, he will share his learnings from the current pandemic with us.

Online meeting Speakers:  Prof. Yves Geysels, Dept of Biomedical Sciences, University of Namur Omer Saka - Partner - Life Sciences and Health Care at PricewaterhouseCoopers Advisory, Capital Projects & Infrastructure

The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

Online meeting about Methods for safety assessment of Covid-19 vaccines at the European level (Xavier Kurz, EMA) incl. Q&A Best practices regarding inspections of the Belgian authorities and remote inspections (Evelien GERITS, Infarama) incl. Q&A