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[V5-S1] Future Steps and Challenges for Drug Development Based on National Action Plan on Antimicrobial Resistance (AMR)
Session Chair(s)
Junko Sato, PHD
Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overcoming Antimicrobial-resistant Infection (ARI) has become a global issue. In 2016, the “Ministerial Meeting on Measures on Emerging Infectious Diseases” has announced the National Action Plan on Antimicrobial Resistance (AMR), and as well as a commitment demonstrated in G7 Health Ministers Meeting to solve AMR task. In addition, for a Guideline for the Clinical Evaluation of Antibiotics for ARI, the three regional regulatory agencies (PMDA/FDA/EMA) are cooperating to continue the discussion. This session will discuss future steps based on AMR action plan, about clinical studies in different framework to date, and on international cooperation.
Speaker(s)
Yasuhide Yamada, MSC
, Japan
The Japanese Government's Efforts on AMR
Wataru Asakura, PHD
Office Director, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Therapeutic Drug for Antimicrobial Resistance (AMR) Infections: from Regulatory Standpoint
Akiko Takase, MPHARM
Senior Scientist, Infectious Diseases, Clinical Research, MSD K.K., Japan
Challenges in Clinical Development of Drugs for AMR Infections
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