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Tuesday, June 29 • 11:30am - 12:30pm
#225 SL: International Coalition of Medicines Regulatory Authorities (ICMRA): Harnessing Achievements During COVID-19 for the Future

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-571-L04-P; CME 1.00; IACET 1.00; RN 1.00

There is an on-going need for coordination, ownership, and oversight of the various changes, improvements, and flexibilities that have emerged through the pandemic. While this is a multipronged problem, the regulatory coordination, flexibility and speed are paramount. ICMRA and their achievements that were the most visible during COVID-19 will be discussed including global regulatory collaboration and its impact during the pandemic. Additionally, a panel discussion on the role of ICMRA for the future of convergence, and the impact of achievements during COVID-19 on its strategic initiatives and technical workstreams will be included.

Learning Objectives

Identify the role and activities of ICMRA; Discuss the collaboration within ICMRA during COVID-19; Describe ICMRA achievements beyond COVID-19.

Chair

Agnès Saint-Raymond, DrMed

Speaker

How Regulatory Cooperation and Convergence has Helped COVID Vaccines Gain Authorization Globally
Charbel Haber, PhD, MBA, MPH

COVID-19 Experience and How ICMRA’s Efforts Supported Development of Vaccines and Therapeutics
Sean Curtis, MD, MPH

ICMRA’s Achievements from the Perspective of NiFDS
Kyung Won Seo

ICMRA Vaccine Pharmacovigilance
John Skerritt, PhD

ICMRA's Achievements From ANVISA's Perspective
Antonio Barra Torres, MD

ICMRA's Achievements From EMA's Perspective
Emer Cooke, MBA, MSc

ICMRA's Achievements From Health Canada's Perspective
Pierre Sabourin, MBA


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 Sean Curtis

Sean Curtis

Senior Vice President, Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc., United States
Sean Curtis heads Global Regulatory Affairs & Clinical Safety at Merck, driving innovative regulatory and safety strategies to enable rapid and efficient licensure pathways and maintain product registration. Previously, he worked over 20 years in Clinical Development; most recently... Read More →
avatar for Charbel Haber

Charbel Haber

Senior Vice President, Head of Regulatory Affairs, Moderna, United States
Charbel Haber joined Moderna in April 2020 as the Senior Vice-President and Head of Global Regulatory Science. In this role, Charbel was responsible of building the global regulatory function to support Moderna’s pipeline including the development and registration of Moderna COVID-19... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... 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 Kyung Won Seo

Kyung Won Seo

Director General, National Institute of Food and Drug Safety Evaluation, Ministiry of Food and Drug Safety, Korea, Republic of
Dr. Kyung Won Seo is the Director General of the National Institute of Food and Drug Safety Evaluation at the Ministiry of Food and Drug Safety Korea since February 2021. Dr. Seo has involved in many toxicological research and studies and reviewed non-clinical data for 15 years. Dr... Read More →
avatar for John Skerritt

John Skerritt

Deputy Secretary for Health Products Regulation, Commonwealth Department of Health, Australia
Dr John Skerritt joined the Australian Department of Health in 2012 and is currently a Deputy Secretary and member of the executive team of the Department of Health. He was formerly the National Manager of the Therapeutic Goods Administration (TGA), until his role was expanded and... Read More →
avatar for Antonio Barra Torres

Antonio Barra Torres

President Director, ANVISA, Brazil
Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →

Tuesday June 29, 2021 11:30am - 12:30pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   14: DIAmond, Forum