Autumn Introductory Course - Day 2 - Slides

Learning Outcomes

● Overview of Research and Development – To introduce how clinical development fits in R&D – To raise awareness of factors and pressures which may influence clinical development ● Steps to get the product to the Market Place – To understand some of the key areas for input including RMP, Post approval Commitments, Pharmacoviligance activities……… The Regulatory Person’s role in these activities

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