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New Approaches to the Approval of Innovative Medicines: Do They Keep Their Promise?
Session Chair(s)
David B. Jefferys, MD, FRCPC
Senior Vice President, EISA EUROPE LTD, United Kingdom
EMA, FDA and PMDA have introduced or are planning to introduce facilitated regulatory pathways aimed at encouraging the development and authorisation of innovative medicines. This session will provide information on these approaches, compare their characteristics and look into their benefits for patients and for industry.
Speaker(s)
Tomas Salmonson, DrMed, PhD
, Critical Path Institute, Netherlands
New Approaches to the Approval of Innovative Medicines: The EMA Perspective
Toshiyoshi Tominaga, PhD
Life Science Department, Advisor, Sunflare, Japan
PMDA’s Approaches to the Approval of Innovative Medicines: How Does Sakigake Work?
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Comparing the Characteristics and Use of Facilitated Regulatory Pathways by ICH and Maturing Agencies
Alastair Kent, MHS
Co-Chair of the UK Rare Disease Policy Board; Former Executive Director, Genetic Alliance UK, United Kingdom
Panel Discussion- Patient Perspective
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