Autumn Introductory Course 2018 - Day 2 Handouts


Learning Outcomes

TOPRA Introductory Course

Clinical (Efficacy) Data from a R&D Perspective

● 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

A presentation by Lynda Troy, Regulatory Consultant


Overview of Research and Development

Role of Regulatory Professional

Putting the pieces together and the role of the regulatory professional in this

Elements to consider

Candidate Attrition Rates

 The Environment  Some facts and figures

 Discovery to Development  Non-Clinical Development  Clinical Development  Registration – Filing and Approval  Summary

Source:PBF R&D GeneralMetrics 2008


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