Writing Annual Reports
Training Overview
The submission of timely and detailed annual reports is required by FDA for the investigational new drug (IND) as well as the marketed product. Providing the step-by-step foundation for regulatory submissions, this comprehensive training course emphasizes the regulations, mechanics and importance of preparing and writing annual reports. The course begins by examining when and how to submit annual reports for both INDs and NDAs. Learn to comply with FDA regulations governing AR submission, and incorporate other periodic relevant reports including IND safety reports and NDA field alerts. Examine common elements of well written SOPs and implement best practices to ensure documentation quality. This course will teach you how to leverage the tools that already exist in your company for writing effective annual reports. Throughout the duration of the course, attendees will have the chance to participate in interactive exercises and group discussions designed to enhance take-away skills and knowledge. Share experiences with colleagues, practice writing sample sections of the annual report and analyze common FDA citations to ensure a better understanding of agency expectations.
Improve your ability to:
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Comply with FDA/ICH requirements in writing annual reports for INDs and NDAs
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Prepare clear, accurate and message driven documentation
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Utilize statistical information, charts and checklists to provide consistency, trending and timeliness
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Identify and utilize specific SOPs to help write an annual report (AR)
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Write effective and well-thought out SOPs
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Format the CMC section of an annual report according to FDA guidelines
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Organize data for an annual report
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Avoid common pitfalls and write effective, approvable annual reports
PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-04-092-L04, Initial release: 04/04.