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Saturday, June 19 • 12:00pm - 1:00pm
#533 OD: Comparing Accelerated Approval Pathways Among EMA, FDA, and PMDA

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Component Type: Session
Level: Intermediate

Early access programs are implemented in EU, Japan, US and many other countries/regions, and many products are approved by utilizing these programs. In this session, speakers share and review the programs and discuss its future direction.

Learning Objectives

Outline early access programs provided by each regulatory agency; Discuss the achievements of the early access programs offered by each regulatory agency; Identify how to foster a dialogue among stakeholders on what is expected for the early access programs to further address regulatory needs.


Nobumasa Nakashima, PhD


FDA Update
Theresa Mullin, PhD

EMA Update
Agnès Saint-Raymond, DrMed

Industry Update
Peter Honig, MD, MPH, FACP

avatar for Nobumasa Nakashima

Nobumasa Nakashima

Associate Executive Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Nakashima joined Ministry of Health, Labour and Welfare (MHLW) in 1992. He spent his career in the international field such as WHO and OECD, not only in the domestic field. He worked as International Planning Director at MHLW since 2014, Director of Office of International Regulatory... 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 →
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 →

Saturday June 19, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   20: Early Access Content, Session