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Thursday, June 30 • 9:00am - 10:30am
#401: EMA/FDA Question Time

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-16-611-L04-P; CME 1.50; IACET 1.50; RN 1.50

This forum will provide an opportunity for EMA and FDA leadership to explore at a roundtable discussion 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 innovation support to industry, use of real world data, patient involvement in the development, evaluation and post-authorization of medicines, and mutual reliance on GMP inspections.

The audience will be invited to submit questions of general interest. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions and topics of interest in advance to annualmeetingprogram@DIAglobal.org, and include “EMA/FDA Question Time” in the subject line.

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, MD, FACP


Emer Cooke, MBA

Dara Corrigan, JD

John K. Jenkins, MD

Jordi Llinares Garcia

Anabela Marcal, PharmD

Heidi C. Marchand, PharmD

Peter W. Marks

Isabelle Moulon, MD

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 Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... 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 →
avatar for Jordi Llinares Garcia

Jordi Llinares Garcia

Head of Research and Innovation, European Medicines Agency, Netherlands
Dr Jordi Llinares is currently the Head of Research and Innovation at the European Medicines Agency (EMA). At the Agency he has had different posiitons including Head of Orphan Medicines, Scientific Support Development and, and Scientific and regualtory management between 2009 and... Read More →
avatar for John Jenkins

John Jenkins

Director, Office of New Drugs, CDER, FDA
Dr. Jenkins is Board Certified in Internal Medicine and Pulmonary Diseases by the American Board of Internal Medicine. He joined FDA in 1992 and has been Director of the Office of New Drugs since 2002.
avatar for Anabela Marcal

Anabela Marcal

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... Read More →
avatar for Heidi Marchand

Heidi Marchand

Assistant Commissioner, Office of Health and Constituent Affairs, OC, FDA
Heidi Christl Marchand, Pharm.D. is currently the Assistant Commissioner for Health and Constituent Affairs at FDA. She has held leadership positions in global regulatory affairs with Novartis, Pfizer and Amgen. Dr. Marchand leads FDA’s office responsible for engaging external stakeholders... 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 Isabelle Moulon

Isabelle Moulon

Head of Patients and Healthcare Professionals Department, European Medicines Agency, European Union
Qualified medical doctor from the University of Grenoble, specialising in endocrinology and metabolic diseases. She joined the European Medicines Agency in 1995. Since 2004, she has been developing the interaction with patients and healthcare professionals and was appointed Head of... Read More →

Thursday June 30, 2016 9:00am - 10:30am EDT
114 Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum