Andrew Hewitt

My goal was to gain a deeper awareness and understanding of what is required in the different sections of a dossier for submission in the EU. I think the course definitely accomplished this and there was lots of useful information, which was very well explained. I can confidently say that I left knowing a lot more than I initially thought I would.

Fantastic webinar! Speakers were very knowledgeable, clear, concise, and open to questions at any time—providing in depth background information were appropriate as well. The content was very interesting and I think a very good amount was covered considering the timescales. I enjoyed the workshop a lot. I thought it was a good way to try and put into practice what we had learnt during the webinars. I also thought a very good amount of information was covered for an introduction into the sections of the dossier.

It was well laid out and formatted especially for myself who does not have a regulatory role currently. I was hoping to achieve a firmer understanding and overview of submission within the EU, and believe I achieved this. [Speakers] were very knowledgable and provided great answers to all questions— supportive but challenged us when doing the workshop. I liked all areas of the course.

Excellent. I was hoping to refresh, add to and update my knowledge. The webinar was excellent to remind me of areas that I had been involved with many years ago and add knowledge that is more relevant to my role now. I found the topics of the workshop particularly relevant.

Very content with the course! The length of each chapter was nicely timed, breaks were ideal. The case we studied was a very good way to summarize all the information [seen] and it generated a lot of interesting questions/dilemmas. I would recommend.

Excellent. Hoped to achieve better understanding of clinical and quality parts of the dossier and this was very well accomplished.

Very nice. I would recommend.

I wanted to get some good practices on how to manage dossier from a strategic and admin standpoint. Recommendations were given during the training so I think info I wanted to get was given.

Excellent presentation with very useful content and information. Great speakers with brilliant experience who were always available to respond any question.

The overall opinion is that the webinar was great.