Principal Scientific Administrator, European Medicines Agency (EMA)
Alison Cave is a Principal Scientific Administrator at the European Medicines Agency within the Pharmacovigilance and Epidemiology Department. She has over 20 years of academic research experience in the cardiovascular field gained in the US and UK. Prior to joining the EMA she was...
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Acting Deputy Commissioner for Global Regulatory Operations and Policy, FDA
Leads a 5,000-member workforce devoted to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. She joined FDA in 2010, serving as...
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Director of Regulatory Policy, Office of Policy, OC, FDA
Director of Regulatory Policy/FDA Office of Policy. Prior to June 2002 worked in Office of Legislation; detailed to Office of Chief Counsel and Acting Director of Office of Crisis Management. Counsel for US House Judiciary Subcommittee and legislative counsel for Member. Attorney...
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Head of Public and Stakeholders Engagement, European Medicines Agency, Netherlands
Juan Garcia Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation of...
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Liaison to the US FDA, European Medicines Agency, European Union
Sabine Haubenreisser, MSc, Ph.D., is a pharmacologist who joined the European Medicines Agency in 1997, where she held a variety of positions including scientific team leader and officer for external communications. In 2012 she was appointed EMA Liaison Official at the U.S. FDA in...
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Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts...
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EMA Liaison Official to FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently...
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Director, Center for Biologics Evaluation and Research, FDA, United States
Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching...
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Dir., Off. of New Drug Products; Dir. (Acting), Off. of Surveillance, OPQ, CDER, FDA
Dr. Miksinski received her B.A. from Earlham College (1994) and her Ph.D. from Oklahoma State University (1999). She served as an NIH postdoctoral fellow from 2000-2002, and began as a CMC reviewer at the FDA in 2002. She is now the Acting Director of ONDQA/DNDQA 2.
Head of Division International Affairs, European Medicines Agency, Netherlands
Agnes is an MD and qualified French Paediatrician. She worked as a paediatrician in a paediatric Hospital in Paris, France, then in pharmaceutical industry, and then moved to the French Medicines Agency. In 2000 she joined the European Medicines Agency (EMA) and was responsible for...
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