Resources
Useful links
Regulatory Agencies
Partners
Organisations
- The Faculty of Pharmaceutical Medicine
- European Society of Cell and Gene Therapy (ESCGT)
- TOPRA
- Parenteral Drug Association (PDA)
- Biotechnology Industry Organisation(BIO)
- UK Bio Industry Association (BIA)
- World Health Organisation (WHO)
- International Conference on Harmonisation (ICH)
- EDQM
- Orphaned
- EU Clinical Trials Register
- US Clinical Trials Register
- Eurordis Rare disease Patient Groups
Factsheets
Click on the link below to download our latest factsheet. We will be adding more in the coming months.
- Orphan Drug Designation (EU & UK)
- Orphan Drug Designation (US)
- The Clinical Trials Regulation and the Clinical Trials Information System
- Preparing for the Clinical Trials Regulation (CTR)
- Scientific Advice US-FDA
- Regulation of Medical and In Vitro Diagnostic Medical Devices in the UK
- Clinical Trials with Genetically Modified Organisms (EU)