All sessions of this unique course online
Live interaction options between the delegates and trainer
Available via mobile, tablet or laptop
Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex environment for pharmaceutical companies to operate. This course will provide a comprehensive, yet practical guide to pharmacovigilance audits and inspections best practice to help navigate what is required to demonstrate compliance.
Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!
Legislative & regulatory background
Inspection preparation & conduct
Critical PV process auditing
Interview readiness & communicating with inspectors
Recommendations and practical hints & tips
PSMF maintenance
Inspectional updates from FDA, EMA & MHRA
Remote audits and inspections
Inspectors’ expectations regarding safety governance in patient support programs
Ancillary Departments role in audits and inspections
Audit Reports and corrective and preventative actions
