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 w...
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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 Engagement Department, European Medicines Agency, European Union
Juan Garcia Burgos is Head of Public Engagement Department and Co-chair of the EMA patients’ & healthcare professionals’ working parties. He is a Medical Doctor specialised in urology. In 2002 he joined the EMA to coordinate the preparation of EU clinical guidelines for drug...
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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 i...
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Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Dr. Kweder has been in her position in 2016, and previously held a number of leadership positions in CDER. Her work there focused on improving review processes to build a high performing organization that values scientific rigor, open discourse and high quality decision making. T...
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Head of Compliance and Inspections Department, European Medicines Agency, European Union
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 and she is currently Head of Committees and Inspections Department.
Director, Center for Biologics Evaluation and Research, FDA
Served as Clinical Director of Hematology at Brigham and Women's Hospital, worked in the pharmaceutical industry on the clinical development of hematology and oncology products, led the Adult Leukemia Service and served as Chief Clinical Officer of Smilow Cancer Hospital. He join...
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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 International Affairs (ad interim), Head of Portfolio Board, European Medicines Agency, European Union
MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medici...
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