Scientific Guidelines

Scientific guidelines (human and veterinary)
  1. Combined Veterinary Dictionary for Drug Regulatory Activities list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
  2. Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products
  3. Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
  4. ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 5
  5. ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management - Step 5 - Annexes