Sandra L. Kweder,
MD
Deputy Director, FDA Liaison to the EMA, Office of International Programs, OC
Dr. Sandra L. Kweder was named Deputy Director of the Europe Office in the FDA Office of International Programs (OIP) in March 2016. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs (OND) in FDA’s Center for Drug Evaluation & Research (CDER), where she actively led numerous initiatives including improvements in the drug review process; modernizing nonprescription drug review; building a systematic drug shortage prevention and management program; patient-focused drug development and clinical outcomes assessments; and the growth and development of pediatric and maternal health as standard aspects of drug development. Dr. Kweder was commissioned in the US Public Health Service upon entering the Uniformed Services University of Health Sciences (USUHS), retiring with the rank of Rear Admiral. Following internal medicine training at Walter Reed Army Medical Center, she joined the FDA Division of Antiviral Drugs to address the growing field of HIV drug development. She has since held a number of positions with FDA in pre- and post-market regulation. Until her move to Europe, Dr. Kweder was an adjunct faculty member of USUHS, training residents and medical students in internal medicine and utilizing her fellowship training from Brown University in obstetric and consultative medicine.
Fellows of DIA
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PhD •Chair, Fellows of DIA
President, Japan Self-Medication Industry -
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JD • President, B-Henry & Associates -
MD, PhD • Pharmacovigilance Expert -
MD • Professor of Clinical Pharmacology, St. Vincent's Hospital -
MBA • President, International Regulatory Affairs Group LLC -
MPH, PhD • Global Chief, Sci Affairs; Sr VP, Head, Center for Advanced Evidence Generation
IQVIA -
PhD • Senior Advisor, Strategic Programs,Center for Drug Evaluation and Research, US Food and Drug Administration -
MD • Senior VP, Chief Medical Officer, Director, Corporate Medical Affairs HQ, Eisai Co., Ltd. -
MBA • Chairman, CISCRP; Director of Sponsored Research, Tufts Center For the Study of Drug Development -
PhD • Corporate Vice President
PAREXEL International -
MD • Senior Vice-President, Industrie Sante -
MD • Deputy Director, FDA Liaison to the EMA, Office of International Programs, OC -
MD • Deputy Director, Integrated Delivery, and Lead for Global Regulatory Systems Initiatives
Bill and Melinda Gates Foundation -
MD, JD • Senior Vice President, Head of Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc. -
MS • Representative, NM Consulting -
PhD • Advisor, Digital Channels and eCapabilities, Eli Lilly and Company -
MD • Chief Medical Officer & EVP, Horizon Pharma, Inc. -
DVM, MBA • Director Biopeople, University of Copenhagen -
PhD • Professor and Director, Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Venture Partner, Lilly Asia Ventures