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Thursday, June 27 • 9:00am - 10:15am
#412: Keeping Up with FDA and EMA Collaborations: Question Time

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-728-L04-P; CME 1.25; IACET 1.25; RN 1.25

How do large regulatory agencies collaborate? What are the challenges they face, in organizations with different structures and working under different legislative frameworks, in finding ways to align to facilitate and enhance global medicines development? This forum brings together pairs of experts from FDA and EMA to launch discussion in such context, with focus on several themes that will provide a foundation for discussing challenges and successes in communication and collaboration covering four areas. These include how we have collaborated on urgent public health issues (with valsartan contamination as an example) and, from there, are working to address shared goals of enhancing global focus on quality manufacturing. From a more clinical perspective, both agencies have matured in experience managing programs for advising companies on potentially important products that could address unmet medical needs, as well as scientific challenges of how to design clinical trials that will be robust and informative in that setting of urgency.

This 75-minute session will engage the audience as a priority, drawing on the extensive experience and expertise of the panel. The audience is invited to submit questions both on the topics explored. Please come prepared with your questions for the EMA/ FDA Question Time panel. You may submit questions in advance to annualmeetingprogram@diahome.org, and include “EMA/ FDA Question Time” in the subject line.

Learning Objectives

Discuss scientific and regulatory challenges of coordinating a response to product contamination on a global scale; Describe factors in developing a strategic approach to globally applicable product quality standards; Identify how the FDA and EMA share information about expedited development scientific advice today and opportunities for the future.


Sandra L. Kweder
Tânia Teixeira, PharmD


Anthony Humphreys, MPharm

Andrew Thomson, PhD, MA, MS

Zahra Hanaizi, PharmD, MPharm

Agnès Saint-Raymond, DrMed, MD

Brad Leissa, MD

Laura Lee Johnson, PhD

Christopher Joneckis, PhD

Peter P. Stein, MD

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 Zahra Hanaizi

Zahra Hanaizi

Scientific officer, PRIME Coordinator, Scientific and Regulatory Management Dept, European Medicines Agency (EMA)
Zahra Hanaizi joined EMA in 2007 as Product Team Leader, managing centralised medicinal products initial marketing authorisation applications, maintenance and life-cycle activities, mostly in the therapeutic area of Oncology. Since 2015, she has been working on the creation, implementation... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency (EMA)
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
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 →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Official at the FDA, European Medicines Agency
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product... Read More →
avatar for Andrew Thomson

Andrew Thomson

Statistician, Methodology Taskforce, European Medicines Agency, Netherlands
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics... Read More →

Christopher Joneckis

Associate Director for Review Management, CBER, FDA
avatar for Brad Leissa

Brad Leissa

Deputy Director, Counter-Terrorism and Emergency Coordination Staff, OCD, CDER, FDA
Brad Leissa began his career at FDA in 1989 as a Medical Officer in the Center for Drug Evaluation and Research (CDER). Following the October 2001 anthrax attacks, Dr. Leissa began work on drug-related regulatory emergencies. In June 2018, he became the lead coordinator for the CDER... Read More →
avatar for Peter Stein

Peter Stein

Director, Office of New Drugs, CDER, FDA
Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related... Read More →

Thursday June 27, 2019 9:00am - 10:15am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  14: DIAmond, Forum