International Regulatory Harmonization Amid Globalization of Drug Development Workshop Summary (2013) / Chapter Skim
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Appendix B: Participant Biographies
Appendix B: Participant Biographies
Pages 91-110
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From page 91... ...
His research and writing focuses on trade, legal, and regulatory issues in global health and development, in particular tobacco and noncommunicable diseases, technological innovation and 91
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From page 92... ...
Senate on international regulatory issues in global health, and his most recent work has appeared in the Journal of the American Medical Association, Foreign Policy, The Atlantic, Clinical Trials, and Stanford Journal for Law, Science & Policy. He is a member of the IOM's Committee for Strengthening Food and Drug Regulation in Developing Countries and has served as a temporary legal advisor to WHO.
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From page 93... ...
Prior to assuming the role of Deputy Commissioner, she served for 5 years as Director of the Office of Compliance of FDA's CDER. In that role, she led policy making and enforcement for key public health programs for drugs, including current good manufacturing practices; human subject protection and bioresearch monitoring; marketing unapproved drugs; pharmaceutical import and export; pharmacy compounding; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls.
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From page 94... ...
While in the Division of Scientific Investigations she was active in developing a risk model for selecting clinical trial sites for inspection, collaborating with EMA and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions.
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From page 95... ...
Dr. Brumfield also served as the com any's head of drug safety surveillance and reporting, and p managed global adverse event reporting requirements and the integration of harmacia's related safety operations.
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From page 96... ...
. He left the public service to join Eisai Co Ltd in June 2007 as the managing director and regional medical director of Eisai Clinical Research Singapore Pte Ltd, to oversee, execute, and manage the growth, development, and operations of the global and regional clinical research activities within the Asia-Pacific, Oceania, and Middle East countries.
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From page 97... ...
He trained in internal medicine and clinical pharmacology at the Vienna University Hospital as well as at Stanford University. James Fitzgerald, B.Sc.
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From page 98... ...
Prior to NRC, she served as Branch Chief and Radiation Safety Officer for the Defense Threat Reduction Agency and as the Radiation Safety Officer/Health Physicist at FDA. Before her employment by the federal government, she worked as a health physics consultant for Krueger-Gilbert Health Physics, Inc., in Maryland and as a nuclear medicine technologist at the Mayo Clinic in Minnesota.
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From page 99... ...
As a staff member of WHO, he has advised more than 40 developing countries, especially in Africa and Asia, on the formulation of their national medicines policy, essential drugs list, and essential drugs program. As secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, he initiated the 2002 changes in procedures for updating the Model List of Essential Medicines, with stronger emphasis on evidence-based selections.
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From page 100... ...
He has postgraduate training and is board certified in internal medicine and clinical pharmacology and has authored numerous peer-reviewed publications and book chapters. He has held senior leadership positions at FDA and Merck Research Laboratories.
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From page 101... ...
Liberti has worked in and with the pharmaceutical industry, in the fields of regulatory affairs and clinical R&D. He began his career at Wyeth Laboratories working in product development, as a regulatory writer in clinical R&D, and as manager of safety surveillance in medical affairs.
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From page 102... ...
He lectures on regulatory issues concerning expediting patient access to medicines, new paradigms of drug development, and ways to improve communications among regulators, HTAs, and sponsors. He serves on the boards of other not-for-profit organizations, including CONTACT Greater Philadelphia (a suicide prevention and elder outreach provider)
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From page 103... ...
, the recipient of the AAPS Regulatory Science Achievement Award, and the University of Wisconsin Pharmaceutical Analysis Excellence Award. Margareth Ndomondo-Sigonda, M.Sc., M.B.A., is Pharmaceutical Coordinator, African Union-NEPAD Planning and Coordinating Agency.
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From page 104... ...
Ray has primary responsibilities for ensuring the safe, effective, and appropriate use of Johnson & Johnson's 1,000-plus pharmaceutical products globally, and for supporting an innovative research pipeline of new medical solutions in areas of unmet patient need. He is chair of the Global Safety Council, the organization's most senior governance body for product safety matters with oversight for identifying, evaluating, and managing medical risk for drugs, biologics, vaccines, and other categories of medicines, across all disease areas from first human exposure through clinical trials and market activity.
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From page 105... ...
His research focus is pharmacoepidemiology, global medicines safety, pharmaceutical outcomes research, and public health systems research. He has served as Chair of the Department of Pharmacy and Department of Pathobiology.
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From page 106... ...
Drug Safety System and the Committee on Strengthening Regulatory Systems in Developing Countries. He serves as a special government employee for FDA, is a Senior Advisor to the Safety Surveillance Working Group of BMGF, and is a member of the Advisory Group to Global Alert and Response for WHO.
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From page 107... ...
Ms. Valdez leads, manages, and coordinates Office of International Programs's staff of about 100 around the world, catalyzing FDA global engagement in collaboration with international health and regulatory partners, ministries of health and agriculture, other U.S.
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From page 108... ...
Zezza has global responsibilities for CMC regulatory strategies and activities for all development products and lifecycle management for commercial products for both small molecule and biologics portfolios. This includes global CMC support and regulatory dossier creation for products in all phases of clinical trials, product development through global product registrations, and product lifecycle support and optimization.
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From page 109... ...
Dr. Zezza has been involved in numerous industry and joint FDA-sponsored initiatives that have supported ICH global harmonization efforts for ICH Q8 Pharmaceutical Development, ICH Q9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality Systems efforts.
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