Advanced Pharmacovigilance 2021 - 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. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments
Strategic level audit planning
Hands on exercise
PV activities and processes subject to PV audit
Speaker:
Michael Ramcharan has 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations