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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 w... 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 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... 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 i... Read More →
avatar for Sandra Kweder

Sandra Kweder

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... Read More →
avatar for Anabela Marcal

Anabela Marcal

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.
avatar for Peter Marks

Peter Marks

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... 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 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... Read More →

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