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.
Senior Director, Head of R&D Audits & Inspections at Jazz Pharmaceuticals
MSc qualified Quality Assurance Professional with 20 years of diverse Pharmaceutical Industry experience based in the UK. Broad expertise in different GxPs e.g., GVP, GCP, GMP and GDP. Areas of subject matter expertise include Audits & Inspections, Quality Management System & Pharmacovigilance System. 8 years of Pharmaceutical Manufacturing experience with Eli Lilly. 12 years in R&D Quality at Shire/Takeda.
Managed and hosted MAH, Supervisory Authority & many local PV system inspections (e.g., UK, EU, China, Saudi Arabia, South Africa, Australia). Managing matrix teams across Research and Development with contributions from Technical Operations and Commercial. Current role includes responsibility across Pharmacovigilance System, GCP and GLP.
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