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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.

Chair

Sabine Haubenreisser
Sandra L. Kweder, MD, FACP

Speaker

Panelist
Emer Cooke, MBA

Panelist
Dara Corrigan, JD

Panelist
John K. Jenkins, MD

Panelist
Jordi Llinares Garcia

Panelist
Anabela Marcal, PharmD

Panelist
Heidi C. Marchand, PharmD

Panelist
Peter W. Marks

Panelist
Isabelle Moulon, MD


Chair
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, Liaison to the EMA, Office of International Programs, OC, FDA
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 →

Speakers
avatar for Emer Cooke

Emer Cooke

Head of International Affairs, European Medicines Agency, European Union
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... 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 Product Development Scientific Support Department, European Medicines Agency, European Union
Jordi Llinares is a medical doctor specialised in clinical pharmacology. He worked as clinical pharmacologist at Hospital de Sant Pau and has experience as member of an ethics committee. Jordi has academic experience as lecturer in clinical pharmacology. He has a Masters degree in... 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

Head of Committees and Inspections Department, European Medicines Agency (EMA),
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 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
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