Learning Outcomes

IPAT Transition to BIRS Symposium at Kilimanjaro School of Pharmacy

As a follow-up to the Quality Culture Leadership Certificate Program in September, 2017, the same community was invited to participate in the IPAT Transition to BIRS Symposium at Kilimanjaro School of Pharmacy. The courses that were provided included current content relevant to industrial applications delivered in collaboration with thought leaders from industry through interactive sessions and practical projects. The goal of the two-week certificate program was so both the unique content (what was taught) and pedagogy (how it was taught) with a collaborative triad of industry scientists, regulatory professionals and academic faculty will help participants effectively adapt and adopt the material for impact in their organizations.

The first course was Innovation and Evidence-Based Natural Medicine, which was taught for the first week. The second week session focused on the final course for the IPAT/BIRS certificate program, Documents and Dialogues for Drug Development and Registration. Topics include: Regulatory Framework, EU/US/WHO and Current State of Harmonization in Africa; Regulatory Framework and Approval Process for Devices, Drug/Device combinations; Interactive Roundtable Discussion on Strategies and Opportunities for Efficient Harmonization in Africa; CFR, ICH Guidances, ANDA Checklist, CTD; Planning for Successful meetings and successful inspections with Health Authorities; Planning for Successful Audits; Interactive Case Study on Regulatory Strategy; Analytical Lab with applications in Analytical Method Validation, Pharmaceutical Development Report and Process Validation.

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