Pharmaceutical Regulatory Science

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The course of 15 lectures are designed to teach students and researchers adequate evaluation of drugs, and to recognize how pharmaceutical sciences works in developing new and efficient drugs that should benefit healthcare. Not only graduate school students but also many nondegree students from the industry or government to take this lecture.

[FY2009] 2009/10/05-2010/02/15 Monday 16:00 - 17:40

#	Lecture Title	Speaker's Affiliation
#1	Regulatory Science and Pharmaceutical Science	Food Safety Commission, Cabinet Office
#2	Overview of Drug Evaluation and PMDA	PMDA (Pharmaceuticals and Medical Devices Agency)
#3	The Principles of Drug Policy and Approval	MHLW (Ministry of Health, Labour, and Welfare)
#4	Quality Control of Biologics (1)	PMDA (Pharmaceuticals and Medical Devices Agency)
#5	Health Policy and Drug Evaluation in Japan	The Universityb of Tokyo, Drug Policy & Management
#6	Theory and Practice of Efficacy Evaluation	The Universityb of Tokyo, Dept of Medicine
#7	Quality Control of Biologics (2)	PMDA (Pharmaceuticals and Medical Devices Agency)
#8	The Principles of Clinical Development and Drug Evaluation	The Universityb of Tokyo, Dept of Pharmaceutical Science
#9	New Drug Evaluation in Japan -the balance of risks and benefits-	NationalCancer Center Hopsital/ The University of Tokyo
#10	Pharmacokinetics in Drug Development	The Universityb of Tokyo, Dept of Pharmaceutical Science
#11	Toxicology Studies	PMDA (Pharmaceuticals and Medical Devices Agency)
#12	Illustration of a Drug Review Procedure (1)	PMDA (Pharmaceuticals and Medical Devices Agency)
#13	Clinical Development	Novo Nordisk
#14	Challenges in Clinical Pharmacology Studies	The University of Tokyo, Hospital
#15	Illustration of a Drug Review Procedure (2)	PMDA (Pharmaceuticals and Medical Devices Agency)

• Graduate School Lectures
• RC (Regular Course)
• IC (Intensive Course)