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Thursday, July 1 • 2:00pm - 3:00pm
#446 L: EMA-FDA Question Time

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-666-L04-P; CME 1.00; IACET 1.00; RN 1.00

The EMA and FDA have a long history of scientific and regulatory collaboration. In this interactive session experts from both Agencies will address questions from the audience and share their experiences of collaboration in specific areas.

Learning Objectives

Describe the regulatory and scientific collaboration between EMA and FDA; Review the experience and explore specific areas of collaboration between the two Agencies; Discuss how the collaboration between the two Agencies contributes to global development and supervision of medicines.

Chair

Anabela Marcal, PharmD
Sandra L. Kweder, MD

Speaker

Development and Use of Medicines in Pregnancy and Lactation: EMA Update
Agnès Saint-Raymond, DrMed

Development and Use of Medicines in Pregnancy and Lactation: FDA Update
Lynne Yao, MD

Parallel Scientific Advice: EMA Update
Thorsten Vetter, DrMed

Parallel Scientific Advice: FDA Update
Shannon Thor, PharmD, MS

Quality/CMC Development in Early Access Approaches: EMA Update
Veronika Jekerle, PhD, RPh

Quality/CMC Development in Early Access Approaches: FDA Update
Laurie Graham


Speakers
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
LG

Laurie Graham

Director, DIPAP, OPPQ, OPQ, CDER, FDA, United States
Laurie Graham is currently the Director of the Division of Internal Policies and Programs (DIPAP) in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drugs Evaluation and Research (CDER). DIPAP is responsible for... Read More →
avatar for Veronika Jekerle

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle joined the European Medicines Agency in 2006. She has been a Product Team Leader for numerous Biological medicinal products applications including Recombinant proteins, Vaccines, ATMPs and Biosimilar applications. In 2014 she became a Quality Specialist within the... Read More →
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 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 Shannon Thor

Shannon Thor

International Policy Analyst, Office of Global Policy & Strategy, Europe Office, FDA, United States
Lieutenant Commander Shannon Thor is a pharmacist and officer in the United States Public Health Service, serving as an international policy analyst in FDA's Europe Office, working closely with European regulatory counterparts to accomplish international public heath goals. Previous... Read More →
avatar for Thorsten Vetter

Thorsten Vetter

Senior Scientific Officer, Scientific Advice, European Medicines Agency, Netherlands
MD, Board certified Clinical Pharmacologist, Senior Scientific Officer, Scientific Advice Office, European Medicines Agency
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Thursday July 1, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   14: DIAmond, Forum
  • Beginner Beginner
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Collaboration,Regulator Thinking,Special Populations
  • Tags Forum