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!
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.
![BLACK BAG - Official Trailer [HD] - Only in Theaters March 14](http://i.ytimg.com/vi/Du0Xp8WX_7I/mqdefault.jpg)
briefing package is due at time of meeting request for type A, otherwise a good general overview
Yes, this is correct
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!
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.
This was AMAZING!!! Thank you for doing this!
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.
@@kyyahabdul okay. Thanks 😊
I want to get into it . Should I get my masters after my pharmd
What's inthe receipt and acknowledge can break that down