References List
2013-03-13
ICH
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European
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World
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French
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US
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Official sites
ICH References
E1 The Extent of Population Exposure to Assess Clinical Safety
E2B (M) Data Elements for Transmission of Individual Case Safety Reports
E3 Structure and Content of Clinical Study Reports
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data
E6 GCP: Consolidated Guideline
E7 Clinical Trials in Special Populations: Geriatrics
E8 General Considerations for Clinical Trials
E9 Statistical Principles for Clinical Trials
E10 Choice of Control Group in Clinical Trials
E11 Clinical Investigation of Medicinal Products in the Pediatric Population
European References
The Rules Governing Medicinal Products in the European Union
Volume 1 - Pharmaceutical Legislation.Medicinal Products for Human use.
Volume 2 - Notice to Applicants.Medicinal Products for Human use
Volume 3 - Guidelines.Medicinal Products for Human use.
Volume 4 - Good Manufacturing Practices Medicinal Products for Human and Veterinary use.
Volume 9 - Pharmacovigilance Medicinal Products for Human and Veterinary use.
Directives
Directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain
(
version anglaise
)
Directive 91/356/CEE de la Commission du 13 juin 1991 établissant les principes et lignes directrices de bonnes pratiques de fabrication pour les médicaments à usage humain
Directive 2001/20/CE concernant le rapprochement des dispositions législatives, réglementaires et administratives des États membres relatives à l’application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain
World References
Declaration of
Helsinki
, Version 2002
French Regulations
Code de la Santé Publique
Partie législative
Partie réglementaire
Bonnes Pratiques
Bonnes Pratiques de Pharmacie Hospitalière (2000)
Déontologie et Bonnes pratiques en épidémiologie (1998
)
Bonnes Pratiques de Pharmacovigilance (1994)
Informatique et Libertés
Loi 94-548 du 1er Juillet 1994
Loi n°78-17 du 6 janvier 1978
FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Electronic Records; Electronic Signatures (21 CFR Part 11)
Human Subject Protection (Informed Consent) (21 CFR Part 50)
Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products (Interim Rule) (21 CFR Part 50, subpart D):
IRB Duties Part ( Part 50.50)
Clinical investigations not involving greater than minimal risk (Part 50.51)
Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects (Part 50.52)
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition (Part 50.53)
Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (Part 50.54)
Requirements for permission by parents or guardians and for assent by children (Part 50.55)
Wards (Part 50.56)
Financial Disclosure by Clinical Investigators (21 CFR Part 54)
Institutional Review Boards (21 CFR Part 56)
Investigational New Drug Application (21 CFR Part 312)
Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
Applications for FDA Approval of a Biologic License (21 CFR Part 601)
Investigational Device Exemptions (21 CFR Part 812)
Premarket Approval of Medical Devices (21 CFR Part 814)
Official sites
http://www.legifrance.com/
http://www.sante.gouv.fr/
http://www.emploi-solidarite.gouv.fr/index.asp
http://agmed.sante.gouv.fr/htm/11/11000.htm
http://www.cnil.fr/
http://pharmacos.eudra.org/
http://www.europa.eu.int/pol/health/index_fr.htm
http://www.ich.org/
http://www.iso.ch/iso/fr/ISOOnline.openerpage?firstTime=true