briefing package is due at time of meeting request for type A, otherwise a good general overview
@kyyahabdul Жыл бұрын
Yes, this is correct
@rbronsing2 жыл бұрын
Nice overview of FDA meeting types! EMA is now in Amsterdam, the Netherlands by the way. Before the pandemic hit, I traveled to EMA (then in London) and also to other countries in Europe to meet with authorities and like you say, it was like a privilege to do that. In fact, in the earlier days, my manager would use it as an incentive. It's very different now. Now, for FDA meetings, I want to regulatory person who works on the product, their manager and myself on the list. And the global project head of that's a scientist and the SME's for the questions. If possible, about the same number of people as FDA sends and not more than 3 more than that. In Europe, it depends but also there, I try to balance it. As for number of questions, for FDA the most I have asked was 12 or so, but really 6 to 10 is better, like you say. In Europe I believe there are rules for the maximum number of questions. In any case, thanks for your video, really nice overview. I'm working on a couple of BBs now.
@mamakay92212 жыл бұрын
I'm starting an Industry fellowship soon in Regulatory Affairs this summer and I'm soaking up all the information you're giving out. Please keep them coming. Thank you!
@Auntyakua2 жыл бұрын
This was AMAZING!!! Thank you for doing this!
@joynwabueze82 жыл бұрын
Thanks for your explanation. The acronyms gets too many and I would pause and try to get the meaning somethings. Waiting patiently for episode 3.
@joynwabueze82 жыл бұрын
@@kyyahabdul okay. Thanks 😊
@adetaiye002 жыл бұрын
What's inthe receipt and acknowledge can break that down
@jlove4eva12342 жыл бұрын
I want to get into it . Should I get my masters after my pharmd