3.    医薬品開発：Pharmaceutical development

3-1. 規制当局：Regulatory Bodies

Japan (PMDA/MHLW):
    PMDA (独立行政法人　医薬品医療機器総合機構　Pharmaceuticals and Medical Devices Agency)
　  MHLW (厚生労働省　Ministry of Health, Labour and Welfare)

US (FDA: Food and Drug Administration):  
　　 Human Drugs

EU (CHMP: -EMA): EMA:　　
　　European Medicines Agency　CHMP: Committee for Medicinal Products for Human Use

3-2. 医薬品業界：Pharmaceutical Industry

  Japan: JPMA: 日本製薬工業協会　Japan Pharmaceutical Manufacturers Association
　　　　政策研(Office of Pharmaceutical Industry Research)

  US: PhRMA: Pharmaceutical Research and Manufacturers of America:
  PhRMA Japan

  EU: EFPIA: European Federation of Pharmaceutical Industries and Associations
　EFPIA Japan

3-3. アカデミア, 産官学共同, Articles：Academia & Collaborations

  ICH: ICH Official Web Site

  日本臨床薬理学会（Japanese Society of Clinical Pharmacology and Therapeutics）

  American College of Clinical Pharmacology

  レギュラトリーサイエンス学会(Society for Regulatory Science of Medical Products)

ARO’s: 一般社団法人ARO協議会

3-4. CROs closely related to Clinical Pharmacology

ICON

Cognigen

Certara

3-5. Interesting articles/meetings: (Link to another page)

Future directions for peptide therapeutics development

Draft agenda -EMA EFPIA Workshop on the importance of dose finding and dose selection for the successful development, licensing and lifecycle management of medicinal products 04?05 December 2014,  30 Churchill Place, Canary Wharf, London E14 5EU:

TEACHING SAFE AND EFFECTIVE PRESCRIBING　IN UK MEDICAL SCHOOLS: A CORE CURRICULUM FOR TOMORROW'S DOCTORS. Simon Maxw and Tom Walley, on behalf of the Clinical Section Committee of the British Pharmacological Society

Biologics, Biomarkers, Genomics and Proteomics Research: A Compilation of Sources

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(The latest modification on Apr. 7, 2019.)