An integral part of any successful regulatory strategy is meeting with a regulatory agency, early and often, to reach concurrence on development plans. To ensure that your strategy is well communicated and that a successful meeting occurs, the process must be seamless. You need to know not only all the components of FDA’s meeting requirements, but the elements that are not requirements but make the process smoother. While some of the concepts are the same, the regulations and meeting content are different. What a company needs to discuss with the Agency during a Pre-IND meeting is quite different than an End of Phase 1 or 2 meeting, and the needs for the Pre-NDA meeting are vastly different from the earlier meetings. All Phase 1-3 meeting types will be discussed and specific requirements will be reviewed.
- Discuss types of FDA meetings
- Plan the timing of the meeting request
- Plan the timing of the meeting package
- Organize the meeting package
- Manage meeting logistics, including who should attend
- Manage meeting decorum
- Conduct meeting rehearsals
- Take meeting minutes and submit them to the Agency
Any part of the development team who wishes to know more about FDA meeting logistics such as regulatory, quality assurance, manufacturing, clinical, project management, and pre-clinical personnel will benefit from this course.
Meredith Brown-Tuttle, R.A.C.
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1.5 hours; 12:00 - 1:30 p.m. Eastern
February 16, 2011