Infinitemarketing Online
AMK
Links

Guidelines

Datenschutz bei der Infinitemarketing

Guidelines

BfArM-Mustertexte für Fach- und Gebrauchsinformationen

 

EudraLex - The Rules Governing Medicinal Products in the European Union

  • Volume 1 Pharmaceutical legislation: Medicinal Products for Human Use
  • Volume 2 Pharmaceutical legislation: Notice to applicants and regulatory guidelines medicinal products for human use
  • Volume 3 Scientific guidelines for medicinal products for human use
  • Volume 4 Good manufacturing practice (GMP) Guidelines
  • Volume 5 Pharmaceutical legislation Medicinal Products for veterinary use
  • Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
  • Volume 7 Scientific guidelines for medicinal products for veterinary use
  • Volume 8 Maximum residue limits guidelines (MRL)
  • Volume 9 Pharmacovigilance guidelines
  • Volume 10 Clinical trials guidelines

 

FDA Guidances Search FDA Guidances

 

GMP Navigator Datenbank mit Suchfunktion für Guidelines

 

ICH International Conference on Harmonization, Guidelines

  • "Quality" Topics, i.e. Q1 Stability Testing, Q3 Impurity Testing
  • "Safety" Topics, i.e. S1 Carcinogenicity Testing, S2 Genotoxicity Testing
  • "Efficacy" Topics, i.e. E4 Dose Response Studies, Carcinogenicity Testing, E6 Good Clinical Practices
  • Multidisciplinary Topics, i.e.
    M1: Medical Terminology
    M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)
    M3: Timing of Pre-clinical Studies in Relation to Clinical Trials
    M4: The Common Technical Document

 

CFR - Code of Federal Regulations Title 21

 

21 CFR Part 11 Übersetzung ins Deutsche (CMC Pharma GmbH)

 

Office of Regulatory Affairs. Compliance References: Title 21 CFR Part 11