DUBLIN, Nov. 3, 2022 (GLOBE NEWSWIRE) — The “Advanced Pharmacovigilance Auditing and Inspections Course” training added ResearchAndMarkets.com Offer.
Virtual live training course for pharmacovigilance audits and inspections
This seminar will also focus on the risk-based approaches in response to COVID-19, including recent legislation to conduct these activities. PV audit strategy planning The course gives an overview of the European Medicines Agency (EMA) guideline on good pharmacovigilance practices (GVP). Module IV requires that risk-based quality system audits be conducted at regular intervals to ensure that it meets the specified quality requirements to determine its effectiveness.
It includes the review of the pharmacovigilance system covered by the quality system. The GVP modules apply to EU-based companies and all companies marketing medicines worldwide. The legally required risk-based audit strategy must cover all PV processes and tasks performed by or delegated to other departments, MAH subsidiaries and third parties such as distributors, external service providers, partners (the PV universe). The PV audit strategy plan is used to prepare the PV audit program, ie the annual PV audit plan.
In this two-day workshop conference, we will discuss the EMA and FDA requirements related to risk-based PV system and quality system audits. The course focuses on the design of…
