Attestato di partecipazione
Introduzione
A quality management system is required to support all pharmacovigilance activities which are essential to monitor the safety profile of veterinary medicinal products.
A suitable and functional quality management system must be in place for evaluating the performance of various pharmacovigilance activities.
A detailed description of the essential components of the quality management system are described in Articles 4 to 9 of Regulation (EU) 2021/1281 and Guideline on veterinary good pharmacovigilance practices, Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files.
The course contents are designed to provide an understanding of the key components of the quality management system including policies, processes and procedures for various pharmacovigilance activities such as document and record management system, data collection, risk management, monitoring of the benefit-risk balance, signal management, communication, maintenance and availability of the pharmacovigilance system master file, and the roles and responsibilities of various personnel involved in pharmacovigilance activities.
In addition, during the course the role of quality assurance for auditing internal Pharmacovigilance System and distributors will be discussed.
- Regulatory framework for quality management system for pharmacovigilance
- Description of quality management system in the pharmacovigilance system master file
- Policies, processes and procedures for:
- document management, training, internal audits and change management
- record management and data collection
- risk management
- benefit-risk balance monitoring
- signal management
- communication plan
- maintenance and availability of the pharmacovigilance system master file
- Roles and responsibilities of various personnel involved in pharmacovigilance activities
- Handling of complaints and deviation, and implementation and evaluation of the effectiveness of corrective and preventive actions
- Training
- Role of quality assurance in veterinary pharmacovigilance
- Change management
- Performance indicators and their role in the continuous performance monitoring of pharmacovigilance activities
- Conduct and planning of internal audits and evaluation of its effectiveness
- Audit management of distributors and risk-based planning
- 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
Interactive training with 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
03 December 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 09/10/2024)
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
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.