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Progress Report on Emerging Nations and Regulatory Capacity Building
Session Chair(s)
Ekopimo O. Ibia, MD, MPH, FRCP
Director, Medical Safety Review
Merck & Co., Inc; FDA Alumni Association International Network, United States
This decade has seen widespread activities by nations, nonprofits, and industry engaging in global regulatory capacity building and strengthening. Hear major initiatives from the Bill and Melinda Gates Foundation, African Medicines Regulatory Harmonization program, and an academic overview of the field and its impact on health, industry, and economy.
Learning Objective : Describe the structure, function, and priorities of the various initiatives for regulatory capacity building; Identify key milestones in the efforts by the Bill and Melinda Gates Foundation, African Medicines Regulatory Harmonization program, and others; Describe the program’s future direction, challenges, and opportunities.
Speaker(s)
Regulatory Systems Optimization for Products for Neglected Diseases
Murray M. Lumpkin, DrMed, MD, MSc
Bill and Melinda Gates Foundation, United States
Deputy Director, Integrated Development, Lead for Global Reg Systems Initiative
Strengthening Regulatory Systems of Emerging Economies: Opportunities and Challenges
Syed Rizwanuddin Ahmad, MD, MPH, FISPE
Drug Safety Consultant, United States
Ex-Consultant/Safety Reviewer, FDA, Assoc Prof (adjunct), Rutgers, Georgetown
Regional Centres of Regulatory Excellence (RCORE): Innovative Regulatory Workforce Development Initiative in Africa
Ekopimo O. Ibia, MD, MPH, FRCP
Merck & Co., Inc; FDA Alumni Association International Network, United States
Director, Medical Safety Review