Nam-Hee Lee,
PhD
Council of Regulators
Ministry of Food and Drug Safety Liaison to the DIA Board
Director, Clinical Trials Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety
Dr. Nam-Hee Lee serves as Director of the Clinical Trials Management Division, Ministry of Food and Drug Safety (MFDS), in the Republic of Korea. She manages all aspects of clinical and non-clinical trials including policy establishment; regulation and protocol approvals; BA/BE protocol and study approvals; GCP compliance inspections; BE/non-clinical/clinical facility qualification; and test animal facility management.
Dr. Lee is a trained pharmacist and joined MFDS in June 1996 after earning her Ph.D. She has worked for the MFDS and the Ministry of Health and Welfare (MoHW) for over 20 years, in various roles. At MFDS, Dr. Lee has served in the Pharmaceutical Policy Division, the Pharmaceutical Approval and Management Division, and as Director of the Cosmetic Policy and Pharmaceutical Approval and Patent Management Divisions. She has also served in the Pharmaceutical Policy Division/Office for Healthcare Policy at the MoHW.
Our Leadership
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Joseph Scheeren,
PharmD •Chair DIA
Senior Advisor R&D
Bayer AG -
John A. Roberts,
MBA •Immediate Past Chair DIA
President and Chief Executive Officer
Cancer Genetics, Inc. (CGI) -
Rebecca Vermeulen,
RPh •Chair-Elect DIA
Head, Product Development Medical Affairs Customer Strategy
F. Hoffmann-La Roche Ltd. -
Jeffrey S. Payne,
CPA, CGMA •Secretary/Treasurer DIA
Chief Financial Officer
Katabat -
Barbara Lopez Kunz,
MS • Global Chief Executive
DIA
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Andrzej Czarnecki,
MD, PhD, DSc •Director DIA
Director, Deputy Qualified Person for Pharmacovigilance, Global Patient Safety
Eli Lilly and Company, Ltd. -
Angelika Joos,
MPharm •Director DIA
Executive Director, Global Regulatory Policy
Merck Sharp & Dohme (Europe) Inc. -
Judith Ng-Cashin,
MD •Director DIA
Chief Scientific Officer
Syneos Health -
Michael Romano,
CPA •Director DIA
Partner, Life Science Industry Practice Group, RSM US -
Michael Rosenblatt,
MD •Director DIA
Chief Medical Officer
Flagship Pioneering -
Jonathan Sheldon,
PhD •Director DIA
Senior Vice President
QIAGEN -
Kihito Takahashi,
MD, PhD •Director DIA
Vice President and Senior Managing Director, Development & Medical Affairs, GlaxoSmithKline Japan -
Lingshi Tan,
PhD •Director DIA
Chairman and Chief Executive Officer
dMed Company Limited -
Cynthia L. Verst,
PharmD •Director DIA
President, R&D Design and Delivery Innovation, IQVIA
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Joseph Scheeren,
PharmD • Chair, Executive Committee
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Jeffrey S. Payne,
CPA • Member, Executive Committee -
John A. Roberts,
MBA • Member, Executive Committee -
Rebecca Vermeulen,
RPh • Member, Executive Committee -
Barbara Lopez Kunz,
MS • Member, Executive Committee
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Michael Romano,
CPA • Chair, Audit Committee -
Andrzej Czarnecki,
MD, PhD, DSc • Member, Audit Committee -
Angelika Joos,
MPharm • Member, Audit Committee -
Joseph Scheeren,
PharmD • Member, Audit Committee -
Cynthia L. Verst,
PharmD • Member, Audit Committee
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Yoshiaki Uyama,
PhD • Chair, Council of Regulators
Leadership Committee
Japan Pharmaceuticals and Medical Devices Agency Liaison to the DIA Board -
Peter Bachmann,
PhD • Council of Regulators
Leadership Committee
European Medicines Agency Liaison to the DIA Board -
Gerald J. Dal Pan,
MD • Council of Regulators
Leadership Committee
US Food and Drug Administration Liaison to the DIA Board -
Petra Dörr,
PhD • Council of Regulators
Swissmedic Liaison to the DIA Board
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Barbara Lopez Kunz,
MS • Global Chief Executive -
Bayard G. Gardineer,
MS, CPA • Chief Financial Officer -
Timothy Hess • Global Director of IT
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Thomas Bols • Senior Vice President & Managing Director
DIA EMEA -
Youngshin Lee,
PhD • Senior Vice President & Managing Director
DIA South Korea and ASEAN -
Sudip S. Parikh,
PhD • Senior Vice President & Managing Director
DIA Americas -
Akio Uemura,
PhD • Senior Vice President & Managing Director
DIA Japan -
Carol Zhu,
RPh, MBA • Senior Vice President & Managing Director
DIA Greater China