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2 Semestre 2017

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12 dicembre 2017

Milano, 09:00-16:00
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13 dicembre 2017

 MIlano, 9:00-17:30
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14 dicembre 2017

 Milano, 9:00-16:00
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GMP Navigator

Abbiamo raccolto in questa sezione un elenco dei link ai documenti di maggior interesse in campo GMP, in modo da facilitarne la consultazione.

USA
FDA
FDA - Newsroom
Warning Letters e Responses Database
FDA - List of Guide to Inspections
CDER Guidance Documents Database
CBER Guideline Database
FDA - Human Drug CGMP Q&A
CFR
CFR Database
21 CFR Part 11: "Electronic Records; Electronic signatures"
21 CFR Part 58: "Good Laboratory Practice for Nonclinical Laboratory Studies"
21 CFR Part 210: "Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs; General"
21 CFR Part 211: "Current Good Manufacturing Practice for Finished Pharmaceutical"
21 CFR Part 606: "Current Good Manufacturing Practice for Blood and Blood Component"
21 CFR Part 820: "Quality System Regulation"
21 CFR Part 1271: "Human Cells, TIssues and cellular and tissue-based Products"
EUROPA
EMA
EMA - What's new?
EMA - Human Medicines GMP Guidelines
EMA - Veterinary Medicines GMP Guidelines
EMA - Scientific Guidelines for Human Medicinal Products
EU - GDP Farma
EU - Human Medicines GMP Major Developments
EU Legislation - Eudralex index
Eudralex - Vol.1 -EU pharmaceutical legislation for medicinal products for human use
Eudralex - Vol.2 - Notice to applicants and regulatory guidelines for medicinal products for human use
Eudralex - Vol.3 - Scientific guidelines for medicinal products for human use
Eudralex - Vol.4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use
Eudralex - Vol.5 - EU pharmaceutical legislation for medicinal products for veterinary use
Eudralex - Vol.6 - Notice to applicants and regulatory guidelines for medicinal products for veterinary use
Eudralex - Vol.7 - Scientific guidelines for medicinal products for veterinary use
Eudralex - Vol.8 - Maximum Residue Limits
Eudralex - Vol.9 - Guidelines for pharmacovigilance for medicinal products for human and veterinary use
Eudralex - Vol.10 - Guidelines for clinical trial
ALTRE
PIC/S: List of Guides from the Pharmaceutical Inspection Convention
APIC: Industry Best Practice Documents
EUR-Lex: l'accesso al diritto dell'Unione europea
EU Dir 2011/62/UE
EU GDP API
INTERNATIONAL COUNCIL OF HARMONISATION
ICH Guidelines index
ICH - Quality Guidelines
ICH Q7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q8: Pharmaceutical Development
ICH Q9: Quality Risk Management
ICH Q10: Pharmaceutical Quality Systems
ICH Q11: Development & Manufacturing of Drug substances
ICH - Safety Guidelines
ICH - Efficacy Guidelines
ICH - Multidisciplinary Guidelines
FARMACOPEE
European Pharmacopoeia
European Pharmacopoeia -International Harmonisation
Farmacopea Ufficiale Segretariato
U.S. Pharmacopeia
British Pharmacopoeia
The Japanese Pharmacopoeia
ITALIA
Parlamento Italiano
Ministero della Salute
Dlgs 50/2007: Attuazione delle direttive 2004/9/CE e 2004/10/CE
Dlgs 219/2006: Attuazione della direttiva 2001/83/CE
Dlgs 193/2006: Attazione della direttiva 2004/28/CE
Dlgs 10/2002: Attuazione della direttiva 1999/93/CE
Dlgs 19 febbraio 2014, n. 17

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