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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.


EMA/ FDA Question Time

    Session Chair(s)
      Tânia  Teixeira, PharmD

      Tânia Teixeira, PharmD

      • EMA Liaison Official at FDA
      • European Medicines Agency (EMA), European Union, United Kingdom
      Sandra L. Kweder, MD

      Sandra L. Kweder, MD

      • Deputy Director, Liaison to the EMA, Office of International Programs, OC
      • FDA, United States
    EMA and FDA leadership come together at a round table discussion on areas covered by the EMA/ FDA confidentiality arrangements and how both agencies contribute to global development and supervision of medicines. Experts from both Agencies who are at the forefront of EMA/ FDA cooperation will explore topics such as innovation support to industry, development of medicines for special populations, challenges on quality of medicines, and data transparency. The audience is invited to submit questions both on the topics explored and of general interest. 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 Objective : 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.
    Speaker(s)
      Giuseppe  Randazzo

      Challenges in Product Quality in Expedited Development Programs

      Giuseppe Randazzo

      • Director, Office of Program and Regulatory Operations, OPQ, CDER
      • FDA, United States
      Peter  Richardson, PhD

      Challenges in Product Quality in Expedited Development Programs

      Peter Richardson, PhD

      • Head of Quality, Specialised Scientific Disciplines Department
      • European Medicines Agency (EMA), United Kingdom
      Ann M. Witt, JD

      Issues in Data Transparency

      Ann M. Witt, JD

      • Counselor to DC for Policy, OND, CDER
      • FDA, United States
      Anne-Sophie  Henry-Eude, PharmD

      Issues in Data Transparency

      Anne-Sophie Henry-Eude, PharmD

      • Head of Documents Access and Publication Service
      • European Medicines Agency (EMA), United Kingdom
      Lucas  Kempf, MD

      Tackling Challenges in Rare Disease Treatments

      Lucas Kempf, MD

      • Acting Associate Director, Rare Diseases Program, OND, CDER
      • FDA, United States
      Kristina  Larsson, MS

      Tackling Challenges in Rare Disease Treatments

      Kristina Larsson, MS

      • Head of Office for Orphan Medicines
      • European Medicines Agency (EMA), European Union, United Kingdom
      Lynne P. Yao, MD

      Pediatrics

      Lynne P. Yao, MD

      • Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
      • FDA, United States
      Agnès  Saint-Raymond, MD

      Pediatrics

      Agnès Saint-Raymond, MD

      • Head of International Affairs, Head of Portfolio Board
      • European Medicines Agency (EMA), United Kingdom