1. This was your 4th CMC Training with Fleming - Do you remember any funny story from them? Or a funny question asked by a delegate or maybe something extraordinary happening...?
I´m German. I really wonder how you came to this question? 😉
2. Do you see any changes in our CMC Courses since the 1st one in terms of delegates, questions...?
Yes, definitively. In the beginning, the concept of how to develop was still not very much known to the audience, thus not only the content but also the questions were mainly covering very general aspects. In the meantime, this has changed. The course content now discusses very specific pitfalls during biosimilar development and the course leaders give particular examples of how to deal with them. One can clearly see that the audience themselves already have significant experience in Biosimilar development. This can be also observed from the contribution of the participants to the course. There is much more in-depth discussion going on now than there was four years ago … and that's great!
3. Did you also learn something new at these trainings? (During panel discussions with delegates or at networking coffee breaks?)
Constantly. There are not only participants from the industry – wholesalers and service providers – but also from regulatory agencies. I love these opportunities to connect with them either during the sessions or during the breaks to learn about their most recent difficulties, trends and opinions. I always try to engage them and their knowledge in our sessions so that everyone can learn from each other and that problems generally common to the industry can be openly discussed.
4. Do you plan to implement something new in the next editions of CMC Training? New topics or new event format?
I always try to evolve the content of the course based on the most recent developments and the feedback from industry and regulators. For the next course, it's time to move away from the general regulations of Biosimilars towards the very specific requirements for analytical comparability. I will introduce new as well as proven concepts based on my experience with US and EU regulators.