An integral part of any successful regulatory strategy is meeting with a regulatory agency, early and often, to reach concurrence on certain 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. This course applies to products currently in Phases 1-3, and does not provide the basics of an Advisory Committee Meeting, negotiating labeling, or postmarketing meetings. 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 (or IDE) 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, specific requirements will be reviewed, and a meeting request template will be provided.
The basics reviewed in this seminar can be applied to both drugs and devices alike
Discuss types of FDA meetings
Apply the regulations and guidance for meeting with the Agency
Develop questions and issues for the meeting request and package
Time the meeting request
Time the meeting package
Organize the meeting package (using the traditional or Target Product Profile format)
Manage meeting logistics (including who should attend)
Manage meeting decorum
Conduct meeting rehearsals
Take meeting minutes and submit them to the Agency
Confirm Agency meeting minute receipt
Ask for clarification if the agency’s meeting minutes do not reflect important discussion points
Examples of mock meeting packages will be provided for discussion and to illustrate how the types of meetings differ at each stage of development
Any part of the device or drug 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 all benefit from this course.
The course will be led by one of the following instructors:
Meredith Brown-Tuttle, R.A.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction to the ABCs and 123s of FDA meetings
- How to develop and track questions and issues for a meeting request and package
- The basic components of a meeting request and timing for submission (this will be a class activity for a mock product or real one if provided by participant)
- Timing of the meeting request and coordination of the team’s schedule
- Scheduling the meeting with the FDA
- Meeting package contents and organization
- Managing the timeline
- Drafting, reviewing, and finalizing the meeting package
- Meeting package submission logistics
- Meeting logistics (where to stay, travel schedule arrangement)
- Meeting decorum
- Meeting rehearsals
- How to take meeting minutes and when to submit them to the Agency
- How to ask for clarification if the Agency’s meeting minutes do not reflect all important discussion points
- Mock Meeting: A mock meeting package will be provided to the participants for reading ahead of the course along with “Rules of Engagement” for the mock meeting. One half of the class will represent a specific discipline from the Sponsor and defend the package while the other half of the participants will represent a specific discipline from the FDA.
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-10-020-L01-P. Released 8/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.