Virtual Seminar 2021 - 3 Days Virtual Seminar on Advanced Pharmacovigilance Auditing and Inspections

PV Audit Strategy Planning course will provide an overview of the European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness.
It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis.
Review of FDA and EMEA requirements for risk based PV audits
The pharmacovigilance system and the quality system
Strategic level audit planning
Speaker:
Cynthia is an accomplished executive director and chief compliance officer with over 17 years’ experience providing first-to-market solutions to the challenges sponsor face whilst using risk management strategies