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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