Regulatory Harmonization Institute - introductory slides

3. Mission and Organizational Structure 3

19. Group/Institutional Members 19

22. Geographical Committees (GCs) 22

26. The RHI Advisory Board 26

27. The Current Advisory Board 26 Martha A. Brumfield, Ph.D.- Dr. Brumfield is the founder of Martha Brumfield Associates, recently serving as Senior Vice President, Worldwide Regulatory Affairs and Quality Assurance at Pfizer Inc. Mary Jane Nehring, Ph.D. - Consultant, formerly Executive Director, Global Regulatory Affairs, at Schering-Plough where she served as the Head of Most of World Region having direct responsibility for Asia Pacific, Latin America, Middle East, Africa, and Eastern Europe. Colin Vickers- Founder of Regulatory Consulting - International, and formerly Head of International Regulatory Affairs for Pfizer where he was responsible for Asia, Latin America, Middle East, Africa and non-EU Europe. Previous to Pfizer, Colin held similar positions at GlaxoWellcome and the Wellcome Foundation. Joseph H Carabello- CEO of CPR Communication, he was responsible for the start up and marketing programs of several HMOs including Oxford Health Plans and Health Care Plan of New Jersey. Mr. Carabello also served as Vice President of Olsten Health Care Services Mark S. Paxton, MS, JD Presently serves as Associate Vice-President, Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (“PhRMA”). While currently responsible for Supply Chain Security, Mark recently served as PhRMA’s worldwide lead for International Regulatory Affairs. Laura Carabello- Founder and principal owner of CPR Communications, Laura has more than 25 years’ experience in business development, marketing, and corporate positioning. Joseph McMenamin, MD, JD - Partner, McGuire Woods, LLP. Joe also is a Fellow of the College of Legal Medicine, a Senior Fellow in the Jefferson School of Population Health, and an Associate Professor of Legal Medicine at the Medical College of Virginia.

31. A Note on Educational and Advocacy Plans (EAPs) 36

33. Structure 36 Advisory Board USA and Europe Northern Asia (China, Japan, S.Korea and Chinese Taipei) Latin America (Coming 2011) Africa (Coming 2012) Geographical Committees (GCs) Educational and Advocacy Plans (EAPs) Formal Procedures Informal Procedures Southeast Asia (Coming 2012) Eastern Europe (Coming 2012) Middle East and India (Coming 2011) 33

34. The Global Regulatory Affairs Map (gRAM) 39

36. Thank You, and we hope you will join RHI! Subscribe to the RHI Brief a free industry newsletter. www.rhibriefs.com