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Tuesday, June 21 • 11:00am - 12:00pm
#224: ICMRA Update: Convergence and Collaboration on COVID-19 - Learning from the Present for the Future

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-661-L04-P; CME 1.00; RN 1.00

This is the second of two sessions looking at the role and contribution of the ICMRA coalition. Following on from the first session on COVID-19 response and international collaboration, this session will focus on lessons learned and regulatory flexibilities and agilities used during the pandemic, and particularly their sustainability post-COVID-19.

Learning Objectives

Describe from a global regulators perspective how they introduced innovative approaches to fight the COVID-19 pandemic; Discuss how the International Coalition of Medicines Regulatory Authorities (ICMRA) provided strategic global leadership; Describe how regulators are discussing which of the agilities and flexibilities could be sustainably retained once the pandemic is over, either for business-as-usual or in future emergency situations.

Chair

Emer Cooke, MBA, MSc

Speaker

Remote and Hybrid Inspections
Paula Walker, MA

Pharmaceutical Quality Knowledge Management System (PQKMS)
Theresa Mullin, PhD

The Role of Regulators in Public Health Response
Antonio Barra Torres, MD


Speakers
avatar for Emer Cooke

Emer Cooke

Executive Director, Chair, ICMRA, European Medicines Agency, Netherlands
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Director for Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads efforts including Patient-Focused Drug Development, Rare Disease Cures Accelerator, and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee... Read More →
avatar for Antonio Barra Torres

Antonio Barra Torres

President Director, ANVISA, Brazil
Mr. Barra, President-Director of Anvisa, graduated in Medicine in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. He also concluded an MBA in Health Services Administration at the Federal University of... Read More →
avatar for Paula Walker

Paula Walker

Head of Compliance (GCP, GPvP, GLP & GxP Expert Circle), Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Paula Walker has been with the MHRA since 2009, joining as a GCP inspector, and subsequently moving to the role of Operations Manager for the GCP team in 2013. Paula is currently the Head of Compliance (1) responsible for the GCP, GPvP, GLP inspections teams and GxP Expert Circle... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session