About
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.
Lecturers
Suzana Šalinger
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 02:00 pm to 06:00 pm CET
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 06/11/2024)
Ordinary: € 610,00*
Freelance – Individual – Academy – Public Administration**:€ 390,00*
* 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.
Register
Barbara Rossi
Training & Quality Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.