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About This Webinar

Pharmacovigilance Audit and Inspections 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.

To this end, pharmaceutical organizations must be able to provide evidence of strong standard operating procedures—on demand. Yet, even today, a majority of companies are still struggling to fulfill their obligations, potentially causing marketing authorization holders (MAHs) to fail inspections, incur fines, and see products withdrawn from markets.

This webinar will give you an insight into the readiness and management as well as practical tips of what works well and where the challenge may be as well as sharing real experiences.

  • Regulatory Framework Applicable to PV Inspections and Audits
  • PV Audits and Inspections Principles and Operational Differences
  • Pharmacovigilance Audit and Inspection Readiness from Auditee and Inspected Perspective
  • PV Audit and Inspection Follow-Up
Language: English
Who can attend? Anyone with the event link can attend
Featured Presenters
Webinar hosting presenter Tiago Barca Ramos
Associate Director of Projects and Qualified Person Responsible for Pharmacovigilance in the EU (EU QPPV), PrimeVigilance
Tiago is a qualified Pharmacist with deep knowledge of Pharmacovigilance legislation and over 10 years of experience in CRO on a global scale for large to mid-size as well as biotech pharma companies. In recent years, Tiago has been supporting pharma companies as a PV consulting Specialist and acting as global EU QPPV/ deputy or Local Contact Person for Pharmacovigilance in Portugal territory. Tiago has experience covering management of PV system under QMS system (Gap Analysis, KPIs, SOPs, CAPA plans, vendor selection, and qualification), maintenance of PSMF, hosting audits and inspections and performing internal and external PV audits. Tiago has successfully guided pharma companies through EU and MHRA inspections and, as a ISO certified auditor who performed several PV audits, Tiago is an expert in setting up and managing global pharmacovigilance systems while cultivating an excellent long-term relationship with clients.
Webinar hosting presenter
PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance offers holistic, top quality, cost-effective, innovative safety services for pharmaceutical, generic, and biotechnology companies. Our founders and leaders have an unrivaled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.
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