Introduzione
Establishment of an effective and functional pharmacovigilance system is mandatory for marketing authorization holders to meet compliance with the requirements stated in Commission Implementing Regulation (EU) 2021/1281, Regulation (EU) 2019/6 and the Veterinary Medicines Regulations 2013 (as amended).
The scope of the system depends on the size of the organization, availability of resources and finances. The named Qualified Person Responsible for Pharmacovigilance (QPPV) is responsible for the implementation and maintenance of pharmacovigilance system.
The course contents are designed to provide an understanding of legal obligations for the establishment of an effective and functional PV system, the essential components of the quality management system, internal quality assurance audits, quality assurance audits of distributors/local representatives, signal management process and the pharmacovigilance system master file (PSMF) which must be prepared and maintained by the marketing authorization holder.
- EU and UK Regulatory framework for veterinary pharmacovigilance.
- Standard operating procedures, polices and guidelines.
- PSMF preparation and maintenance.
- Procedures for performance monitoring and evaluation for the effectiveness of processes.
- Pharmacovigilance database (paper or Microsoft excel based system or specific software IT system exclusively for pharmacovigilance activities).
- System for adverse event receipt, its recording, follow-up, VeDDRA and storage Data input, review and data analysis tools for signal detection, benefit-risk, and trend analysis (in-house tools and EV VET data warehouse), signal management process.
- Internal quality assurance audits and risk assessment.
- Quality assurance audits of distributors/local representatives.
- Volume of sale submission in UPD.
- Pharmacovigilance sales submission to the VMD.
- Pharmaceutical professionals already working in Veterinary Pharmacovigilance
- Veterinary pharmaceutical professionals planning to undertake QPPV and/or Deputy QPPV roles
- Quality assurance and regulatory affairs professionals
Participant experience
Basic understanding of veterinary pharmacovigilance
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 – 1 module
08 October 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 17/09/2025)
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.
Newsletter
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
