戻る Agenda
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)
New Approaches to the Approval of Innovative Medicines: The EMA Perspective
Tomas Salmonson, DrMed, PHD
Critical Path Institute, Netherlands
PMDA’s Approaches to the Approval of Innovative Medicines: How Does Sakigake Work?
Toshiyoshi Tominaga, PHD
SunFlare Co., Ltd, Japan
Life Science Department, Advisor
Comparing the Characteristics and Use of Facilitated Regulatory Pathways by ICH and Maturing Agencies
Lawrence Liberti, PHD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science
Panel Discussion- Patient Perspective
Alastair Kent, MHS
Genetic Alliance UK, United Kingdom
Co-Chair of the UK Rare Disease Policy Board; Former Executive Director