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Recorded Webinar
Conducting Successful FDA Meetings
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Communicating with FDA to determine as much a possible about their expectations regarding product submissions, clinical study design, and other regulatory requirements is a challenge for every regulated business, but critical for drug and device firms. FDA has recently formalized this meeting process and this webinar will help prepare you to handle the new FDA requirements for meetings, and conduct successful meetings.
How will this benefit your company? FDA meetings can be a critical factor in the timeliness of FDA review and approval. It allows the firm to pose critical questions for FDA and gain more understanding of FDA expectations. In addition, a face to face meeting allows the firm to establish an identity with FDA reviewers that can greatly assist future communications.
What can happen if you are not familiar with FDA meeting reasons and requirements? You may not meet with FDA when a meeting is prudent and necessary or even worse, meet with FDA and have the meeting go badly because you were not properly prepared.
Key goals of the Webinar will include:
- Become familiar with the types of FDA meetings that FDA welcomes
- Know how to prepare an FDA meeting request in accordance with recent FDA proposed guidelines
- Know the format and contents of a meeting request.
- Become familiar with the types of FDA persons who conduct meetings with Industry
- Know the type of questions appropriate to ask FDA, and inappropriate to ask FDA
- Preparing an agenda for the meeting
- Who should attend the meeting representing your firm
- How to prepare your team for the FDA meeting
- How to serve as the central spokesperson of your team at the FDA meeting
- How to judge your success after the FDA meeting
- Preparing a meeting summary for FDA
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