Session 12: How To Work With The US FDA When You Can’t Meet With Them
by Jim DiBiasi
In this webinar, Jim DiBiasi sits down with industry experts and key opinion leaders to discuss the latest insights, developments, and learnings on COVID-19 from across the global biopharma and medtech industry
“What we tell our sponsors is, “you have to go in there with a credible, scientific presentation. So, you address all of the benefits and all of the risks, so the right decision is made”. And if having cameras on helps that communication occur, that’s what we all want. I do believe that having that face-to-face contact, even if it’s over a camera, is absolutely essential.”
“Sponsors have to get really good at projecting and showing the passion and clarifying and verifying that they have answered the question that was asked to the satisfaction of the person who asked the question.”
“One other element that the FDA is working on, it seems like they’re working on it, because I’ve seen continuous improvement is the effectiveness of the chairperson and running a very efficient meeting it becomes much more difficult for the chairperson to run the meeting especially when they have 12 to 15 people. . .to have that interactive training between the chair people and the actual advisory committee members on protocol I think is going to be essential.”
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This webinar was originally aired online with Pharma Intelligence on July 21st, 2020.