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Wednesday, June 17 • 8:00am - 9:00am
#304.1 L: ICH 30th Anniversary: Achievements and Future Prospects

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Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-563-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will celebrate the key successes of the ICH Association in recognition of its 30th anniversary highlighting how the Association has evolved to respond to the increasingly global market and new advances in pharmaceutical development.

Learning Objectives

Identify key accomplishments of the ICH Association since it was founded in 1990; Discuss how ICH guidelines have contributed to more efficient drug development and increased patient access to pharmaceuticals worldwide; Explain how the reforms completed in 2015 have expanded the global reach of ICH and increased participation from regulators and industry around the world.

Chair

Amanda Marie Roache, MS

Speaker

MHLW/PMDA Perspective
Nobumasa Nakashima, PhD

European Commission Perspective
Lenita Lindström-Gommers, LLM

FDA Perspective
Theresa Mullin, PhD

IGBA Perspective
Nicholas Cappuccino, PhD

Panelist
Peter K. Honig, MD, MPH, FACP

Panelist
Celia Lourenco, PhD



Speakers
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related international regulatory policy, advocacy in... Read More →
NC

Nicholas Cappuccino

Consultant, Compliance, Quality and Scientific Affairs, Dr. Reddy's Laboratories
Dr. Cappuccino is currently a Consultant for Dr. Reddy’s Laboratories Inc., located in Princeton, NJ, USA. Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic and Biosimilar Medicines Association (IGBA) and represents IGBA on the ICH... Read More →
avatar for Celia Lourenco

Celia Lourenco

Director General, Biologic and Radiopharmaceutical Drugs Directorate, HPFB, Health Canada, Canada
Celia Lourenco, PhD is the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs and Asia Training Centre, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima holds the position of Associate Executive Director for International Programs and Asia Training Centre (ATC) at PMDA since January 2020. Before this position, he had joined MHLW in April 1992, where he worked as Director of Office of International Regulatory Affairs... Read More →
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
Lenita Lindström-Gommers is a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is responsible for international relations in the field of pharmaceuticals. Her main work relates to ICH where she was closely involved... Read More →
avatar for Peter Honig

Peter Honig

Senior Vice President Global Regulatory Affairs and Group Head Development China, Pfizer Inc, United States
Peter Honig, M.D., M.P.H, is the Senior Vice President and Head of Worldwide Safety and Regulatory at Pfizer with expertise in clinical pharmacology, clinical program and clinical trial design, compliance, medical product safety, and medical product regulation. He is a past President... 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 →


Wednesday June 17, 2020 8:00am - 9:00am EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum