Pharmacovigilance Audit Failures: What’s Still Going Wrong?

Life Sciences, Clinical Trials,
  • Thursday, December 10, 2020

When the current European pharmacovigilance (PV) legislation came into force in Europe in 2012, pharmaceutical companies targeting the region had to put in place a number of formal measures to monitor the safety of products and any issues once those products were being marketed in the real world.

These measures also mandate that life sciences companies must run, check and document their PV activities, so that regulating authorities can be confident that standards are being upheld and that nothing is being missed.

This means pharmaceutical organisations must be able to provide evidence of strong standard operating procedures on demand, and that includes measures implemented down the supply chain. Yet, even today, companies are still struggling to fulfil their obligations, causing marketing authorisation holders (MAHs) to fail inspections, incur fines and see products withdrawn from markets.

Arriello’s Vanessa Fachada and Peter Kohut discuss some of the common and potential points of vulnerability with commercial as well as safety and reputational implications, and what companies can do to reduce those risks.


Vanessa Fachada, Arriello s.r.o.

Vanessa Fachada, Pharmacovigilance Manager and EU QPPV, Arriello s.r.o.

Vanessa Fachada is a Pharmacovigilance Manager and EU QPPV at Arriello. She has a Masters Degree in Pharmaceutical Sciences and over 7 years of experience in pharmacovigilance, working in both the Pharmaceutical Industry and with Consultancies. She is also an ISO 9001 qualified internal audit auditor. Since 2014, Fachada has acted as a deputy EU QPPV and/or EU QPPV for several companies and has extensive knowledge of MedDRA codification, xEVMPD, EU-RMP creation and PSUR medical writing.

Message Presenter
Peter Kohut, Arriello s.r.o.

Peter Kohut, Director of Drug Safety and EU QPPV, Arriello s.r.o.

Peter Kohut is the Director of Drug safety at Arriello and an experienced EU QPPV. Kohut’s deep technical knowledge of pharmacovigilance helps clients understand the current PV framework, and allows him to develop custom, tailored PV systems that ensure effective risk management and compliance throughout the product lifecycle. Kohut started his career doing research in the field of biochemistry and later moved into the pharmaceutical industry where he has worked for over 8 years holding various positions both in clinical trial and post-marketing safety.

Message Presenter

Who Should Attend?

  • Heads and Directors of Drug Safety, Pharmacovigilance, Product Safety
  • Heads and Directors of Procurement/PV Procurement
  • Heads and Directors of Commercial/Business Development
  • Heads and Directors of Quality Management Systems
  • Pharmacovigilance Auditors and Inspectors

What You Will Learn

  • A snapshot of why companies are still failing audits and inspections
  • Common gaps in pharmacovigilance systems
  • Performing a gap analysis to avoid audit failures

Xtalks Partner


Arriello has been a leading provider of risk management and compliance services to the Life Sciences sector since 2008. These include Market Consultancy, Global Regulatory Affairs strategy and implementation, Full and Local Pharmacovigilance solutions, Clinical Drug Safety, and Quality and Compliance auditing and systems.

Our brief is simple; to make the process from development to market faster, better and smarter.

Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa. We currently operate in 143 countries with the ability to expand this as required.

With our in-house expertise, vendor network, ISO 9001 certification, years of experience and satisfied clients, including global Originators, Biotech’s, Generics and CRO’s, you can be confident in our ability to deliver as a trusted partner.

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