A Look at Global Regulatory Affairs - Orin Chisholm, PhD, BSc, GCULT

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ASU Clinical Research Management Presents:

Orin Chisholm, PhD, BSc, GCULT

Dr. Orin Chisholm is the Program Director and Senior Lecturer in Pharmaceutical Medicine at UNSW Sydney, a position she has held since December 2012. After extensive experience in regulatory affairs roles in the pharmaceutical industry, facilitating the registration of complex oncology, fertility and orphan disease products, she moved into academia to develop graduates who could make meaningful contributions to medicines research, working across the pharmaceutical industry, academia and government, with the goal of improving the health and wellbeing of communities. Dr Chisholm is also a member of the Gene Technology Technical Advisory Committee, a federal government advisory committee on the use of gene technology in Australia. Dr Chisholm has a Bachelor of Science degree with Honours in Biochemistry, a Graduate Certificate in University Learning and Teaching, and a PhD in Molecular Oncology.

About the presentation:

A Look at Global Regulatory Affairs

With the international moves towards harmonisation of pharmaceutical regulatory affairs, it is now more imperative that practitioners have a global perspective and understand the regulatory systems across the globe. Regulatory professional should be able to evaluate the regulatory systems globally in order to successfully submit application for the marketing of new drugs. Clinical research and regulatory professionals lack a global understanding of the differences between country regulations and submission processes impacting the submission and approval on medical products outside of their country, which in turn limits access of new drugs to consumers.

Outcomes:

• Outline authorization procedures in different countries and illustrate with examples
• Define regulatory intelligence/strategy as it relates to global regulatory affairs
• Identify two of the major challenges facing global regulatory affairs