Conforum event

Third Party Audit Management
Presentation at Conforum 2024.

February 22, Prague, The Czech Republic

Pharmacovigilance Seminar Presentation.

We are excited to announce that one of our speakers, Monika Čičová, Arriello’s Quality and Compliance Specialist, will be presenting at the Conforum: “Farmakovigilance aktuálně a přehledně” 2024 conference on February 22, 2024, in Prague, the Czech Republic.

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Monika Čičová
Quality & Compliance Specialist

About the speaker.

Meet Arriello’s Quality & Compliance Specialist, Monika, a PhD candidate in clinical pharmacy and a pharmacist by training – part of our Quality and Compliance team.

A former EU Senior GVP Inspector, GCP Inspector (in training), she has extensive proficiency of these GXP requirements and legislation in the field of pharmacovigilance. Participating in more than 30 inspections, as a member of PV inspector’s working group and while participating in the EMA international inspection team, Monika has gained broad PV expertise.

In addition to GVP inspection training, she has received EMA training on the mandatory use of the ISO/ICH E2B (R3) ICSR standard in the EU, and is fully trained in MedDRA.

Presentation Summary:

The presentation will summarize knowledge on third party audit management.

  • Legislation requirements – what, why, how, when and who should audit.
  • All auditing levels – strategical, tactical and operational, with a focus on tactical and operational level.
  • Description / definition of audit strategy (briefly), which is the basis for the annual audit plan (tactical level).
  • The tactical level / annual audit plan – will describe how to create the plan and what to take into consideration.
  • Third party audits – describing the whole audit process – every step in detail and the challenges involved.

About the Conference:

The Conforum: “Farmakovigilance aktuálně a přehledně” 2024 conference is the leading event for pharmacovigilance professionals in Central and Eastern Europe. The conference will cover a wide range of topics, including current legislation, risk management, reporting, and inspections.

Register for the Conference:

This conference and session is held in Czech and Slovak language.

You can register on the Conforum website here! 

We hope to see you there!

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