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Thursday, June 22 • 10:45am - 12:00pm
#412: EMA/ FDA Question Time

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this forum, EMA and FDA leadership will engage in a round table discussion on areas covered by the EMA/FDA confidentiality arrangements and discuss how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/FDA collaboration will explore topics such as use of real-world data, data transparency, mutual recognition agreement on GMP inspections and quality of medicines.

Learning Objectives

Summarize key issues discussed by EMA and FDA; Identify regulatory hot topics; Discuss the areas covered under the bilateral cooperation between EMA and FDA aimed at bringing new medicines to patients throughout the world while assuring consistent standards of quality, efficacy and safety; Identify how to engage both agencies in the development of a medicine at the same time.


Sabine Haubenreisser
Sandra L. Kweder


Real World Data: EMA Perspective
Alison Cave, PhD

Real World Data: FDA Perspective
Peter W. Marks, MD, PhD

Transparency: EMA Perspective
Juan Garcia-Burgos, MD

Transparency: FDA Perspective
Jarilyn Dupont, JD

Mutual Recognition Agreement on GMP Inspections: EMA Perspective
Anabela Marcal, PharmD

Mutual Recognition Agreement on GMP Inspections: FDA Perspective
Dara Corrigan, JD

Quality of Medicines: EMA Perspective
Agnès Saint-Raymond, MD

Quality of Medicines: FDA Perspective
Sarah Pope Miksinski, PhD

avatar for Alison Cave

Alison Cave

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... Read More →
avatar for Dara Corrigan

Dara Corrigan

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... Read More →

Jarilyn Dupont

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... Read More →
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García 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... Read More →
avatar for Sabine Haubenreisser

Sabine Haubenreisser

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... Read More →
avatar for Sandra Kweder

Sandra Kweder

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... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US 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... Read More →
avatar for Peter Marks

Peter Marks

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... Read More →
avatar for Sarah Pope Miksinski

Sarah Pope Miksinski

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.
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

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... Read More →

Thursday June 22, 2017 10:45am - 12:00pm CDT
S105 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  12: DIAmond, Forum
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  • Featured Topics Global Regulatory,Public Policy,StudentProgramming
  • Credit Type CME, IACET, RN
  • Tags Forum