NEWS – Pharmacovigilance Audits and Inspections Navigation New 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potentially causing marketing authorization holders (MAHs) to fail inspections, incur fines, and see products withdrawn from markets.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.

Choose between one of 3 sessions available for this webinar on January 27th:

• Session 1: 27 Jan, 6am EST / 11am GMT / 12pm CET
• Session 2: 27 Jan, 10am EST / 3pm GMT / 4pm CET
• Session 3: 27 Jan, 2pm EST / 7pm GMT / 8pm CET

Agenda:

• 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

At the end of the webinar, you will have the opportunity to ask our experts any questions you may have.

 

About our expert speaker:

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 systems 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 an 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.

 

If you have any questions about our webinar please feel free to contact us