Introduzione
The implementation of adverse event reporting, signal management and the continuous safety evaluation of veterinary medicinal products by trained and competent personnel is one of the essential requirements of the EU pharmacovigilance legislation and the guidelines on good veterinary pharmacovigilance practice.
All personnel involved in adverse event reporting and signal management should have received specific training according to their role profile.
The objective of this course is to provide an understanding of the requirements for the collection, reporting and recording of suspected adverse events in the Union pharmacovigilance database (EV VET 3, Eudravigilance Veterinary), the various processes and procedures involved in veterinary signal management, data sources for signal management, annual statement submission in the IRIS portal, uploading of sales volumes to the UPD, regulatory inspection and the importance of veterinary pharmacovigilance communication in the benefit-risk assessment process.
- Regulatory framework for veterinary pharmacovigilance reporting
- Electronic data submission portals and applicable reporting requirements
- Structure and processes for the collection, recording, analysis, validation and reporting of suspected adverse events in the EV VET database/Union Pharmacovigilance Database
- Use of VeDDRA terminology for reporting suspected adverse reactions in animals and humans
- Signal detection and analysis using EV VET Data Warehouse and in house system
- Signal reporting and submission of safety variation
- Preparation of annual statement and its submission in the IRIS portal
- PSUR and its submission to the VMD
- Submission of volume of sale in the UPD
- Planning and conduct of audit on licensing partners
- Handling of regulatory inspection and findings
- Requirements of veterinary pharmacovigilance communication plan
QPPV, deputy QPPV, PV QA, Safety Officer, Pharmacovigilance Manager, Pharmacovigilance Staff.
Participant’s Experience
Knowledge of Regulation 2019/6, Implementing regulation 1281/2021 and VGVP guidance.
Two-module course with lecture delivery using presentation slides, interactive workshops and breakout sessions for discussion.
Docente/i
Jyoti Soni-Gupta
Jyoti is an accomplished animal health professional with extensive experience in veterinary pharmaceutical industry. She is a qualified veterinarian and has PhD in Veterinary Medicine from University College Dublin, Ireland. She has also obtained multiple professional qualifications in clinical research and medical writing, international regulatory affairs, specialist diploma in (bio) pharmaceutical regulatory affairs, and in quality management and statistics from different Universities. She has expertise in pharmacovigilance, regulatory affairs, quality assurance, technical writing, auditing and preclinical/clinical/post-marketing studies.
In 2016, she had established the ZIVA Health Regulatory Consultancy, a multi-specialist consultancy which provides pharmacovigilance, quality assurance, regulatory affairs and technical/medical writing services to the small-medium enterprise (SME), start-up and established national and international veterinary pharmaceutical companies. She has established pharmacovigilance system for different companies and acts Qualified Person Responsible for Pharmacovigilance. She provides pharmacovigilance training to staff and maintains pharmacovigilance system in compliance with regulatory requirements. She is a member of Pharmacovigilance Working Group of different professional associations. She is also a member of TOPRA and RQA.
Online Training – 2 modules
Module 1 | 24 February 2025 from 2:00 pm to 6:00 pm CET
Module 2 | 26 February 2025 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: € 895,00* until 03/02/2025
Ordinary: € 1.095,00*
Freelance – Individual – Academy – Public Administration**: € 640,00*
* 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.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
