Introduzione

The objective of this course is to comprehensively understand the variations of veterinary medicinal products in accordance with the latest regulations and guidelines.

This online training will provide an overview of the veterinary EU variation legislation and available guidance; including advice on the preparation and submission of variations applications.

Variations legislation

  • New EU legislation
  • Variations Not Requiring Assessment (VNRA)
  • Variations Requiring Assessment (VRA)

Practical aspects advice and recommendations for VNRA

  • Technical grouping
  • Consequential VNRAs
  • UPD submission of VNRA

Grouping and Work-sharing

  • those who are working for organisations operating within the European Union with marketing authorisation for veterinary products,
  • those from human regulatory affairs, who want an understanding in how variations are managed in the veterinary sector,
  • new regulatory personnel.

Interactive training, discussion and practical approach.

Docente/i
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 – 1 module

27 November 2024 from 2:00 pm to 6:00 pm CET

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: € 480,00* (until 06/11/2024)

Ordinary: € 610,00*

Freelance – Individual – Academy – Public Administration**: € 360,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

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 06/11/2024
€480,00
Ordinaria
Acquistabile fino al 26/11/2024
€610,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 26/11/2024
€360,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Assess requirements, conditions, and documentation for variations to be classified as not requiring assessment
Risultato atteso
Gain skill to use the UPD platform for submission of VNRA
Risultato atteso
Assess requirements for variation to be classified as requiring assessment
Risultato atteso
Best apply grouping and work-sharing procedures
Risultato atteso
Understand how to classify a variation and prepare an application for submission
<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>
Vedi tutte le edizioni
Veterinary Marketing Authorisation Variation in EU