This week has been intense and very rich in learnings. The richness of this training comes by large from the speakers/teachers who bring their real-world experiences of the field and their vision of the regulatory history and future changes in Europe. This enabled us to learn from very concrete and diverse real examples but also allowed

It was very helpful to get an overview of all aspects to be considered in regard to the pre-clinical to the clinical phase, especially the regulations referred to. So it’s easier to read through the one or the other part later on when required.

For people who have (almost) no knowledge of the vaccine world, this course is very interesting as different aspects are touched and the basics are explained. The interactive sessions are also a plus to applying the content learned in other sessions.

Good general training on the topic with an overall good understanding of the approach to be taken for system audits, and the criticality of some systems.

I found the course extremely helpful. The slides and content were very well structured and presented and Kirsten simply was amazing as a trainer and presenter. I also liked Sanofi’s presentation sharing experience made working in CTIS.

I gained more awareness and knowledge about requirements to move from the pre-clinical to the clinical setting. I was very satisfied with the course content and the high expertise of the presenters.

I have gotten much more knowledge about the legal aspects of NDAs and CTAs and now know better how to critically view their content. The trainer was very communicative and open to questions, with really good and insightful answers.

Being able to set up and manage Risk Management for clinical studies. Well organised, good trainers. I did appreciate this blended approach in learning.

I had an overall (all-inclusive) overview of CPM + tips and tricks for on the job (cf. annexes, documents, workshops). I liked the positive engagement with and the classroom's motivation, of the teacher and co-attendants.

Good refresh and good tips on conducting medical devices clinical trials. Very interactive training with the opportunity to share experiences between trainees and trainers.