“Good Pharmacovigilance Practices (GPP) Guide Module XI - Post-Marketing Benefit/Risk Assessment” aims to provide guidance on organizing the information requested by TMMDA concerning the subject.
“Good Pharmacovigilance Practices (GPP) Guide Module X - Pre-Marketing Benefit/Risk Assessment” aims to clarify the key observations and uncertainties of the benefit/risk assessment.
You can reach the guidelines via the links below:
https://lnkd.in/dx9eju7w
https://lnkd.in/dnAHa8ua