U.K. MRHA & NHS Approvals

Watch UCL’s Prof. Nigel Ratcliffe provide an overview of Regulatory Affairs

PharmaAlliance Regulatory Affairs slide deck.

Learning Objectives

1. To comprehend the multifaceted structure of regulatory affairs within a company
2. To understand that regulatory affairs contributes and drives all elements of Medicine development and this includes strategy of research targets, pre clinical development, clinical development, prescribing information, manufacture, promotion and post marketing activity.
3. To have an awareness of the form and function of the regulatory affairs organisation in a pharmaceutical company.
4. To have an awareness of the interactions (structured and informal) and their importance between the pharmaceutical company and the national regulatory agencies.
5. To be able to enter a pharmaceutical industry career with an informed awareness of the importance and governance of regulatory affairs to successful delivery of the medicines and the business
6. To provide an introduction and awareness to the vast array of opportunities for individuals within regulatory affairs
7. To provide some insight into the requisite thinking and character of a regulatory professional.

External Resources

European Regulatory Affairs

FDA Centre for Drug evaluation and Research

Japan Regulatory affairs MHLW