DIA 2018 Global Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-696-L04-P; CME 1.50; IACET 1.50; RN 1.50

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 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

Tânia Teixeira, PharmD
Sandra L. Kweder, MD

Speaker

Challenges in Product Quality in Expedited Development Programs
Giuseppe Randazzo, MS

Challenges in Product Quality in Expedited Development Programs
Peter Richardson, PhD

Issues in Data Transparency
Ann M. Witt, JD

Issues in Data Transparency
Anne-Sophie Henry-Eude, PharmD

Tackling Challenges in Rare Disease Treatments
Lucas Kempf, MD

Tackling Challenges in Rare Disease Treatments
Kristina Larsson, MS

Pediatrics
Lynne P. Yao, MD

Pediatrics
Agnès Saint-Raymond, MD