Cookie confirmation

PUBLICATIONS / NUMBER 129

Stay on top of all key Pharmacovigilance Regulatory requirements

We do the search and bring you the regulatory information you need to achieve compliancein your Pharmacovigilance operations.

Dec 2016

Dec 2016

SAFETY OBSERVER N129

14 PAGES

  • ICH adopts modernized ICH E6 (R2) GCP Guideline

  • ICH to begin work for new ICH E19 guideline on safety data collection

  • EMA issues draft revision of 2007 guideline on first-in-human clinical trials

  • FDA issues final guideline on use of ICH E2C(R2) PBRER format

  • New FDA Warning Letter and French Injunction Letter over Pharmacovigilance

Receive release updates for free
Register now

Back issues