Introduzione

The European regulatory framework for veterinary medicinal products requires strict compliance with pre- and post-market procedures to ensure product safety, quality, and efficacy.

The process of obtaining a Veterinary Marketing Authorisation (MAA) involves compiling a detailed dossier covering clinical and safety documentation. Additionally, any changes to authorised veterinary medicinal products must adhere to specific variation procedures under EU regulations.

This interactive training course provides a structured approach to understanding the MAA dossier requirements, focusing on clinical and safety documentation, and offers insights into key MAV processes, including Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA).

Participants will gain hands-on experience in preparing critical regulatory documents and best practices for managing variations efficiently.

This course is beneficial for regulatory professionals seeking a deeper understanding of EU veterinary medicinal product authorisation and variation management.

  1. Veterinary Marketing Authorisation (MAA) in the EU
    • Structure of the MAA dossier for veterinary medicinal products
    • Key documentation: Detailed and Critical Summaries (DACS) – Efficacy & Safety, User Risk Assessment (URA)
    • Practical session: Gathering and preparing clinical and safety documentation with examples
  1. Veterinary Marketing Authorisation Variations (MAV) in the EU
    • New EU legislation
    • Variations Not Requiring Assessment (VNRA)
      • Technical grouping
      • Consequential VNRAs
      • UPD submission of VNRA
    • Variations Requiring Assessment (VRA)
    • Grouping and Work-sharing

Regulatory specialists, Veterinary Medical Advisors and personnel working for organisations operating within the European Union with marketing authorisation for veterinary products.
Professionals working in human regulatory affairs, who want to understand how variations are managed in the veterinary sector.

Participant experience
No experience required.

Interactive training, discussion and practical approach.

Docente/i
Jana Brajdih Čendak
Info

Jana Brajdih Čendak

Medical and Pharmacovigilance Lead at Billev Pharma East

Jana started her professional career as a practicing physician, specializing in Emergency Medicine. After almost 10 years in clinical practice, she joined Sanofi’s Medical Affairs team, covering Southeast and Central European countries. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position, Jana is responsible for a team of pharmacovigilance specialists, medical advisors, and veterinary medical advisors, covering human and veterinary pharmacovigilance and providing medical regulatory support to clients.
Her daily work involves preparation of MAA dossiers for human and veterinary medicinal products. She also acts as QPPV for human and veterinary products in the EU and UK.


Suzana Šalinger
Info

Suzana Šalinger

Regulatory Affairs Manager at Billev Pharma East

Suzana Šalinger is experienced CMC regulatory affairs manager with a solution-focused approach. Proficient in drug development processes and life-cycle management across the pharmaceutical industry. Skilled in preparing, evaluating, and analysing quality CMC dossiers for EU/RU/ROW markets. With extensive experience in regulatory affairs, Suzana Šalinger is proficient in coordinating and preparing regulatory submissions and strategies. Her role at Billev Pharma East involves effective communication with competent authorities, clients, and internal departments. She excels in maintaining up-to-date knowledge of European legislation.


Online Training – 2 modules

Module 1 | 19 May 2025 from 2:30 pm to 5:30 pm CEST
Module 2 | 21 May 2025 from 2:30 pm to 5:30 pm CEST

Some 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: € 744,00* until 28/04/2025

Ordinary: € 934,00*

Freelance – Individual – Academy – Public Administration: € 535,00*

* 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 28/04/2025
744,00
Ordinaria
Acquistabile fino al 18/05/2025
934,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 18/05/2025
535,00
Svuota

Mara Claudia Algarotti
Mara Claudia Algarotti
Training Manager & MW Operations
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the structure of the MAA dossier for veterinary medicinal products.
Risultato atteso
Know the structure and content of the required clinical and safety-related documentation for a veterinary MAA.
Risultato atteso
Understand the data requirements and assessment methodology required for preparing the DACS and URA.
Risultato atteso
Prepare high-quality clinical documents to support a veterinary MAA.
Risultato atteso
Assess requirements, conditions, and documentation for variations to be classified as not requiring assessment and for variation to be classified as requiring assessment.
Risultato atteso
Gain skills to use the UPD platform for submission of VNRA.

<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>