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Thursday, June 23 • 10:00am - 11:00am
#415: EMA-FDA Question Time

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-657-L04-P ; CME 1.00; RN 1.00

In this interactive session experts from EMA and FDA will address questions from the audience and share their experiences of collaboration in specific areas, including regulatory and scientific challenges and lessons learned in a COVID-19 environment.

Learning Objectives

Analyze the regulatory and scientific collaboration between EMA and FDA; Discuss the experience and explore specific areas of collaboration between the two Agencies; Describe how EMA and FDA addressed regulatory and scientific challenges in a COVID-19 environment and discuss lessons learned.

Chair

Sabine Haubenreisser, PhD, MSc
Katherine Tyner, PhD

Speaker

Panelist
Elizabeth Miller, PharmD

Panelist
Priya Bahri, PhD, RPh

Panelist
Lynne Yao, MD

Panelist
Marco Cavaleri, PhD

Panelist
John Farley, MD, MPH

Panelist
Richard Forshee, PhD

Panelist
Roberto Conocchia, MSc

Panelist
Georgy Genov, MD



Speakers
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 Priya Bahri

Priya Bahri

Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Marco Cavaleri

Marco Cavaleri

Head of Health Threats and Vaccines Strategy, European Medicines Agency, Netherlands
Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present) Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009) Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008) Scientific Administrator, European... Read More →
avatar for Georgy Genov

Georgy Genov

Head of Pharmacovigilance Office, Quality and Safety of Medicines Department, European Medicines Agency, Netherlands
Dr Georgy Genov is qualified as medical practitioner. He joined the pharmaceutical industry in 1998. Since then he has gained experience in Drug Development, Medical Affairs and Pharmacovigilance. In 2010, he joined the Pharmacovigilance and Risk Management team of the European Medicines... Read More →
avatar for Roberto Conocchia

Roberto Conocchia

GMP technical Lead, European Medicine Agency (EMA), Netherlands
Roberto Conocchia is a GMP Technical Lead at the European Medicine Agency (EMA) since March 2018. He obtained a Master degree in Bio-Chemistry from the University of Rome (La Sapienza) and a Post-graduate master’s degree in Natural substances and bio-organic Chemistry. Roberto worked... Read More →
JF

John Farley

Director, Office of Infectious Diseases, OND, CDER, FDA, United States
Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation... Read More →
avatar for Richard Forshee

Richard Forshee

Deputy Director, OBPV CBER, FDA, United States
Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products... Read More →
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 →
avatar for Elizabeth Miller

Elizabeth Miller

Assistant Commissioner For Medical Products and Tobacco Operations, ORA, FDA, United States
Dr. Elizabeth Miller recently rejoined the US FDA in March 2020. In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical... Read More →


Thursday June 23, 2022 10:00am - 11:00am CDT
Room 184 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  14: DIAmond, Forum