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Thursday, June 20 • 9:15am - 10:15am
#415: EMA-FDA Question Time

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-690-L04-P; CME 1.00; RN 1.00

In this interactive forum experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas as well as on how both Agencies collaborate in addressing current regulatory, scientific, and communication challenges.

Learning Objectives

Identify an overall understanding of the regulatory and scientific collaboration between EMA and FDA; Describe experience and explore specific areas of collaboration between the two Agencies; Examine how EMA and FDA are addressing regulatory and scientific challenges in new areas.

Chair

Anabela Marcal, PharmD
Katherine Tyner, PhD

Speaker

Panelist
Kerry Jo Lee, MD

Panelist
Adam C Fisher, PhD

Panelist
R. Angelo De Claro, MD

Panelist
Evdokia Korakianiti, PhD, MSc

Panelist
Steffen Thirstrup, MD, PhD

Panelist
Francesco Pignatti, MD


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 →
avatar for Katherine Tyner

Katherine Tyner

FDA Liaison to the EMA, Office of Global Policy and Strategy, OC, FDA, United States
Dr. Katherine Tyner is the FDA liaison to the EMA. Dr. Tyner joined FDA in 2007 and has held numerous positions within CDER to advance the quality, safety, and efficacy of complex drug products. In her most recent role as the Associate Director for Science in the Office of Pharmaceutical... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Kerry Jo Lee

Kerry Jo Lee

Assoc. Dir. for Rare Diseases; Program Manager, Advancing Rare Disease Cures Pro, FDA, United States
Dr. Kerry Jo Lee is a graduate of Princeton University and of the New York University School of Medicine with an honors degree conferred in microbiology. She completed residency in pediatrics at the Children’s Hospital of Los Angeles and a post-doctoral clinical fellowship in Pediatric... Read More →
AF

Adam Fisher

Director, Enterprise Project Staff, OQA, OPQ, CDER, FDA, United States
Adam Fisher, PhD., is the Director of Enterprise Project Staff in the Office of Pharmaceutical Quality and lead of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative at the U.S. FDA. He has been a primary and secondary reviewer of generic drug applications... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum |   14: DIAmond, Forum