Introduzione

The Qualified Person for Pharmacovigilance (QPPV) in the veterinary field is responsible for ensuring the continuous monitoring of the safety of veterinary medicinal products (VMPs).

They oversee the collection, assessment, and reporting of adverse events, ensuring compliance with regulatory requirements to safeguard animal and public health.

In this course you will learn about requirements and best practices on the QPPV oversight of the quality management system and processes to ensure full compliance of the system with Regulation (EU) 2019/6 and Veterinary Good Pharmacovigilance Practice (VGVP) guidelines.

  • Legislative background
  • Vet pharmacovigilance requirements in the new Regulation
  • Quality Management System for VMPs
  • PHV processes in scope of VGVP
  • Case studies, examples and best practices

Regulatory and Pharmacovigilance specialists, involved in veterinary medicinal products lifecycle management.

Participant experience
No specific experience is required to follow this course.

Presentation with case studies and interactive Q&A sessions.

Docente/i
Klemen Rojnik
Info

Klemen Rojnik

MPharm - Medical and QA manager at Billev Pharma East Ltd

Klemen holds a PhD in Pharmacy, with a focus on the cost-effectiveness of health care interventions, specifically in breast cancer screening. He also earned a Bachelor of Science in Pharmacy, where he conducted research on the influence of experimental design in bioequivalence studies.
Klemen Rojnik is a seasoned pharmaceutical professional with expertise in pharmacovigilance, quality assurance, regulatory affairs and medical management. He currently manages pharmacovigilance, quality assurance activities, and medical support, while also contributing to bioequivalence studies, toxicological reports, and reimbursement submissions. Previously, he has led local and international research studies, focusing on clinical trials and pharmacoeconomic applications for medicinal products.


Online Training – 1 module

29 September 2025 from 2:00 pm to 6:00 pm CEST

Few days before the online training 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: € 480,00* (until 08/09/2025)

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration: € 390,00*

* for Italian companies: +22% VAT

The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 08/09/2025
480,00
Ordinaria
Acquistabile fino al 28/09/2025
610,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 28/09/2025
390,00
Svuota

Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand Regulatory Requirements – Demonstrate a clear understanding of the legal obligations of the Veterinary QPPV under Regulation (EU) 2019/6 and Veterinary Good Pharmacovigilance Practice (VGVP) guidelines.
Risultato atteso
Implement Effective Oversight – Apply best practices to oversee the quality management system (QMS) and key pharmacovigilance processes, ensuring continuous compliance with regulatory expectations.
Risultato atteso
Identify and Mitigate Risks – Recognize potential compliance risks within the pharmacovigilance system and implement proactive measures to mitigate them.
Risultato atteso
Ensure Audit and Inspection Readiness – Establish robust documentation, monitoring, and reporting systems to maintain readiness for internal audits and regulatory inspections.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training</em></p>