3.    ˆγ–ς•iŠJ”­FPharmaceutical development

3-1. ‹K§“–‹ΗFRegulatory Bodies

Japan (PMDA/MHLW):
    
PMDA (“Ζ—§s­–@l@ˆγ–ς•iˆγ—Γ‹@Šν‘‡‹@\@Pharmaceuticals and Medical Devices Agency)
@
  MHLW (ŒϊΆ˜J“­Θ@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. ˆγ–ς•i‹ΖŠEFPharmaceutical Industry

  Japan: JPMA: “ϊ–{»–ςH‹Ζ‹¦‰ο@Japan Pharmaceutical Manufacturers Association
@@@@­τŒ€(Office of Pharmaceutical Research)

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

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

3-3. ƒAƒJƒfƒ~ƒA, ŽYŠ―Šw‹€“―, ArticlesFAcademia & Collaborations

  ICH: ICH Official Web Site

  “ϊ–{—Տ°–ς—Šw‰οiJapanese Society of Clinical Pharmacology and Therapeuticsj

  American College of Clinical Pharmacology

  ƒŒƒMƒ…ƒ‰ƒgƒŠ[ƒTƒCƒGƒ“ƒXŠw‰ο(Society for Regulatory Science of Medical Products)

AROfs: ˆκ”ΚŽΠ’c–@lARO‹¦‹c‰ο

3-4. CROs closely related to Clinical Pharmacology

ICON-GloboMax

Cognigen

Pharsight

 (—L) ƒŒƒMƒ…ƒ‰ƒgƒŠ[ƒTƒCƒGƒ“ƒXŒ€‹†Š

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 Jul 7, 2016.)