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 member of the device or drug development team who wishes to know more about FDA meeting logistics, Regulatory, Quality Assurance, Manufacturing, Clinical, Project Management, and Pre-Clinical personnel will all benefit from this course.
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.
- Participants will create a meeting request for their own product or a mock one (a template will be provided electronically)
- Participants will hold a mock FDA meeting
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 Melissa Dolen 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-13-032-L01-P. Released 9/13.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.