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 and Regulation (EU) 2019/6.
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 two-module course has been designed to provide a complete understanding of the essential requirements of the pharmacovigilance system for veterinary medicinal products in accordance with the guidelines on good pharmacovigilance practices and current EU regulations.
The course will provide knowledge to identify the scope of pharmacovigilance system, the resources required for set-up and maintenance, pharmacovigilance internal and authority inspections, the key components of quality management system, signal management process, EMA systems and the details on pharmacovigilance system master file (PSMF) with the support of interactive workshops.
- Regulatory framework for veterinary pharmacovigilance system
- QPPV appointment and their roles and responsibilities for the establishment and maintenance of pharmacovigilance system
- PSMF preparation and maintenance
- Procedures for performance monitoring and evaluation for the effectiveness of processes
- Standard operating procedures, polices and guidelines
- 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 analysis tools for signal detection, benefit-risk, and trend analysis (in-house tools and EV VET data warehouse) – signal management process
- Contractual/sub-contractual arrangements with third parties for outsourced pharmacovigilance activities
- Safety data exchange agreement with authorized distributors
- System and processes for initial and refresher staff training
- Internal audits, and procedures for CAPA preparation and implementation
- Authority/Agency inspection, agenda, preparation, execution, and final report
- Roles and responsibilities of key personnel involved in pharmacovigilance operations
- Subcontracts tasks, Local representative responsibilities and agreements
- EMA database, annual statement and volume of sale submission
- Records, maintenance and archive
- Communication with stakeholders (authority, animal health worker and others)
- 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 – 2 modules
Module 1 | 22 October 2024 from 02:00 pm to 06:00 pm CEST
Module 2 | 23 October 2024 from 02:00 pm to 06:00 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: € 895,00* (until 08/10/2024)
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.
Registrati
Ilaria Butta
Events & Training Manager
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.
