Name: #405: EMA - FDA Question Time
Start: 2025-06-19T09:00:00-0400
End: 2025-06-19T10:00:00-0400

Thursday June 19, 2025 9:00am - 10:00am EDT

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-672-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

Speaker

Artificial Intelligence
Luis Pinheiro, PharmD, MSc

Advanced Manufacturing
Manuel Osorio, PhD

GCP
Kassa Ayalew, MD, MPH

GCP
Peter Twomey, MA, MPharm

Artificial Intelligence
Tala Fakhouri, PhD, MPH

Speakers

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States

Dr. Kassa Ayalew is Division Director for the Division of Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research in FDA. Dr. Ayalew oversees the review of integrity of efficacy and safety data submitted to the FDA and the... Read More →

Corinne de Vries

Head of Translational Sciences Office, European Medicines Agency, Netherlands

Corinne is a pharmacist and an epidemiologist (PhD) and has an MA in medical ethics and law. She has gained 20 years’ research experience in academia before making the move to the regulatory environment. Throughout her career, she has worked in multinational and multicultural environments... Read More →

Luis Pinheiro

Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce, European Medicines Agency, Netherlands

Luis Correia Pinheiro is a Senior Epidemiology Expert at the Data Analytics and Methods Taskforce, Real World Evidence Workstream, in the European Medicines Agency, where he designs and conducts real-world data studies and works on digital methods development. He also coordinates... Read More →

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 →

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands

Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation of standards in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting the revision... Read More →

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →

Manuel Osorio

Senior Scientist for Emerging Technologies, OD, CBER, FDA, United States

Manuel Osorio is the lead for the Advanced Technologies Program in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to this role, Dr. Osorio was a researcher/reviewer for 16 years in the Office of Vaccines Research and Review... Read More →

Thursday June 19, 2025 9:00am - 10:00am EDT
146BC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

09: Regulatory, Forum

Level Intermediate
Keyword Regulator Perspectives, Student Programming
Level Intermediate
format csv
Credit Type ACPE, CME, RN
Feature Topics Regulator Perspectives,Student Programming
Tags Forum

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