Dr. Junko Sato is an Office Director of Office of International Program at Pharmaceuticals and Medical Devices Agency (PMDA). She joined Regulatory Agency in 1998. She became a review director […]
Dr. Junko Sato is an Office Director of Office of International Program at Pharmaceuticals and Medical Devices Agency (PMDA).
She joined Regulatory Agency in 1998. She became a review director of Office of New Drug in 2004 and moved to Office of Safety in 2009 to develop a new risk management system through life cycle of drugs. During the period, she visited U.S.FDA as a guest reviewer from September 2002 to March 2003. From May 2012 to April 2014, she was dispatched to EMA as MHLW/PMDA Liaison. She enhanced collaboration between EMA and MHLW/PMDA and brought a huge success as the liaison.
She contributed to some global harmonization activities, for example, ICH, CIOMS etc. She also contributes many DIA activities. She received DIA Outstanding Service Award 2010.
She led the activities of PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) including planning/conduct of all the trainings, and contributes to building stronger bilateral relationship with ASEAN countries by playing the role as the contact point. She also works for AMR project like EMA-FDA-PMDA tripartite meeting to discuss convergence on approaches for the evaluation of antibacterial drugs. She is an Infection Control Doctor certificated by The Japanese Association of Infectious Disease.