Introduzione
Good Pharmacovigilance Practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union.
GVP modules 3 and 4 outline the requirement to conduct inspections and risk-based audits of the PV System. There are also local country specific legislative requirements mandating the same.
Pharmacovigilance audit activities should verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.
Regulatory Agencies must inspect marketing authorization holders (MAH) with centrally authorized products that had located the pharmacovigilance system master file (PSMF) in the UK, against the pharmacovigilance requirements laid down in Titles IX and XI of Directive 2001/83/EC as amended (‘the Directive’), on behalf of the European Medicines Agency (EMA).
The regulatory agencies typically take a risk-based approach to inspections. These can be onsite or remote or a combination.
Inspections requested by the EMA’s Committee for Medicinal Products for Human use (CHMP). The inspections maybe conducted by one or multiple agencies.
The scope may be GVP or a combination of GxP and/or MAH responsibilities therefore it is essential to understand the scope of such audits and inspections and how to be ready and manage such processes.
This advanced course will give you an insight into the readiness and management and practical tips of what works well and where the challenge may be as well sharing real experiences from Industry of approaches taken by regulators, focus areas and examples of observations.
