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.
- The regulatory framework (GVP III and IV for EU)
- Audits, inspections and “Gap Analyses”, operational differences
- Which documents should always be ready (in case of advance requests)
- Which documents can be asked for during the audit/inspection
- What inspectors/auditors look for
- EMA: Findings (minor, major, critical), examples and case histories
- FDA: violations that warrant a warning letter
- What inspectors cannot ask for
- Remote audits and inspections
- Common findings (industry Experience)
- How to organize the first response
- From findings to CAPAs (examples)
- Sanctions/Penalties
- Future of audits and inspections
PV managers, Quality representatives, Consultants working in the PV/QA area, PV subject matter experts.
Participant’s experience
Working in PV, Subject matter expert who would participate in the readiness, management or as a subject matter expert in Audits and Regulatory Agency Inspections with at least 2-year experience.
Lecture and scenarios, practice writing SMART CAPAs.
Docente/i
Raj Bhogal
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.
Online Training – 2 modules
MODULE 1 | 17 June 2025 from 09:30 am to 12:30 pm CEST
MODULE 2 | 19 June 2025 from 09:30 am to 12:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 775,00* (until 27 May 2025)
Ordinary: € 965,00*
Freelance – Individual – Academy – Public Administration**: € 545,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
