戻る Agenda
EMA/FDA Question Time
Session Chair(s)
Tânia Teixeira, PharmD
EMA Official at the FDA, European Medicines Agency, United States
Sandra Kweder, MD
Principal, Drug and Biological Products , Eliquent Life Sciences, 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)
Challenges in Product Quality in Expedited Development Programs
Giuseppe Randazzo, MS
Vice President, Sciences and Regulatory Affairs, Association for Accessible Medicines, United States
Challenges in Product Quality in Expedited Development Programs
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Issues in Data Transparency
Ann M. Witt, JD
Counselor to DC for Policy, OND, CDER, FDA, United States
Issues in Data Transparency
Anne-Sophie Henry-Eude, PharmD
Head of Documents Access and Publication Department, European Medicines Agency, Netherlands
Tackling Challenges in Rare Disease Treatments
Lucas Kempf, MD
Vice President, RCS, Parexel, United States
Tackling Challenges in Rare Disease Treatments
Kristina Larsson, MS
Head of Orphan Medicines, Division for Human Medicines Evidence Generation, European Medicines Agency, Netherlands
Pediatrics
Lynne Yao, MD
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Pediatrics
Agnès Saint-Raymond, DrMed
Head of Division International Affairs, European Medicines Agency, Netherlands