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 all the components of the FDA’s meeting requirements as well as 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
- Regulatory Professionals
- Quality Assurance Personnel
- Manufacturing Personnel
- Clinical Research Professionals
- Project Managers
- Pre-Clinical Personnel
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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 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#: 0778-0000-11-037-L01-P. Released: 2/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.