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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.

Chair

Sandra L. Kweder
Tânia Teixeira, PharmD

Speaker

Panelist
Anthony Humphreys, MPharm

Panelist
Andrew Thomson, PhD, MA, MS

Panelist
Zahra Hanaizi, PharmD, MPharm

Panelist
Agnès Saint-Raymond, DrMed, MD

Panelist
Brad Leissa, MD

Panelist
Laura Lee Johnson, PhD

Panelist
Christopher Joneckis, PhD

Panelist
Peter P. Stein, MD



Speakers
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 Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... 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 →
LL

Laura Lee Johnson

Director Division 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 International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for Tânia Teixeira

Tânia Teixeira

EMA Liaison Official at FDA, European Medicines Agency (EMA)
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 →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
Andrew Thomson is a statistician in the Office of Biostatistics & 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 subgroup of ICH... Read More →
CJ

Christopher Joneckis

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

Brad Leissa

Deputy Director and Emergency Coordinator, 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
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA