Resources

Useful links

EMA legislation and guidance

• Eudralex
• EMA guidance on non-clinical testing

EUPATI

• Intro to clinical development
• Non-clinical testing
• Manufacturing

o Manufacturing, labelling and packaging of investigational drugs

o Formulation 

o European pharmacopoeia: Quality standards for medicines

EU science hub

• Toxicokinetics

International Committee on Harmonization (ICH)

• Quality guidelines
• Safety guidelines
• Efficacy guidelines
• Multidisciplinary Guidelines