Back to Agenda
[DIAmond Session 2] To Deliver Innovative Drugs to the Patients Appropriately and Quickly – Recent Topics and Visions for Future of Regulatory Authorities among US, EU and Japan
Session Chair(s)
Yasuhiro Fujiwara, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Lots of efforts have been made by academia, industry and regulatory agencies, in order to deliver innovative drugs to patents quickly. In this session, representative from FDA, EMA and MHLW will introduce their own activities as well as examples and they will discuss future direction under the recent high-uncertainly environment. The discussion includes their accelerated approval process (ie. FDA: Breakthrough designation, EU: PRIME and Japan: Sakigake) would how to be applied to accelerate appropriate medicine to patients. Also, how efficacy and safety of new therapy to rare disease, where usually typical double-blind trial is difficult to be conducted, is to be evaluated with sufficient validity from scientific and ethical point of views, in order to be delivered to the patients. Efforts by regulatory authorities to incorporate emerging novel science and regulatory science into the processes to establish new medicine, as well as the various collaboration among academia, industry and regulatory agencies globally, will be discussed by the presenters as panel discussion format.
Speaker(s)
Early Access Mechanisms: EMA Experience with Oncology Drugs
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
To Deliver Innovative Drugs to the Patients Appropriately and Quickly
Kazuhiko Mori, PhD, MSc
Japan Pharmaceutical Manufacturers Association (JPMA), Japan
Senior Managing Director
US Food and Drug Administration Expedited Programs for Serious Conditions
Rajeshwari Sridhara, PhD
FDA, United States
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA
Have an account?