Regulations & Guidances current as of :

(GCP-4) good clinical practice

Conducting Pharmaceutical and Medical Device Clinical Research in the European Union (EU)

Additional EU/EEC Regulations and Guidances
  • 90/385/ EEC Council Directive Relating to Active Implantable Medical Devices
  • 93/42/EEC Concerning Medical Devices
  • EU 2005/28 EC GCP Guidelines for Investigational Medicinal Products for Human Use; Requirements for Authorisation to Manufacture or Import Such Products
  • EU 536/2014 On Clinical Trials On Medicinal Products For Human Use, and Repealing Directive 2001/20/EC
  • The WMA Declaration of Helsinki (October 2013)
ICH guidelines (as included in the us code for federal regulations)
  • Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
  • development safety update report e2f
  • Integrated Addendum to Good Clinical Practice
  • General Considerations for Clinical Trials

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(GCP-1) Good Clinical Practice (GCP) in FDA-Regulated Drug and Biologics Clinical TrialsBuy Now
(GCP-2) Good Clinical Practice (GCP) in FDA-Regulated Medical Device Clinical TrialsBuy Now
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(GCP-4) Conducting Pharmaceutical and Medical Device Clinical Research in the European Union (EU)Buy Now
(GMP-1) Current Good Manufacturing Practice (cGMP) for Investigational New Drugs and Biologics Intended for Use in Clinical TrialsBuy Now
(GLP-1) Good Laboratory Practice (GLP) in FDA-Regulated Drug and Biologic Nonclinical and Preclinical Trials
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