NIS Useful Links

eConsent and eSignatures
EU - EMA, ENCePP, Eudralex and GDPR

 

 

 

EU - Post-Authorization Safety Studies (PASS)

 

 

 

Observational Study Reporting Guidelines and Checklists - STROBE
Patient Reported Outcomes (PROs) - FDA, PCORI, ISPOR and PROMS
Pharmaceutical self-Regulatory Bodies - EFPI and PhRMA

 

Registry Quality Standards (for EU HTA Acceptance)
Regulatory Use of Real World Evidence (RWE) - EMA and FDA Guidance

 

UK - HRA and NIHR