Scientific Guidelines

Scientific guidelines (human and veterinary)

  1. ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4

    ICH S5 (R3) guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - step 5 - Revision 4

  2. VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs)

    VICH GL42: Pharmacovigilance: data elements for submission of adverse event reports (AERs)

  3. VICH GL35: Pharmacovigilance: electronic standards for transfer of data

    VICH GL35: Pharmacovigilance: electronic standards for transfer of data