Research and Innovation

Summary of Product Characteristics (SmPC) & Investigator’s Brochure Checks

PV Office – Handling Drug Alerts

PV Office – Processing for Non-CTIMP Studies

Completion Guidelines: Generic Non-CTIMP Serious Adverse Event Form

PV Office – Creation and submission of Development Safety Update Reports

PV Office Processing for Clinical Trials of Investigational Medicinal Products

PV Office – Pharmacovigilance File

PV Office – Submitting SUSAR reports to MHRA via ICSR

PV Office – Expediting SUSARs

PV Office – Preparation of Sponsor Safety Reporting Plan, Glasgow Clinical Trials Unit (GCTU) Pharmacovigilance (PV) Office