Introduzione

Understanding of the regulatory framework for veterinary pharmacovigilance is one of the essential requirements for professionals aiming to begin their journey in this discipline. All personnel involved directly or indirectly in pharmacovigilance activities at various levels in an organisation must be trained and competent for the undertaking of assigned roles.

The goal of this introductory course is to provide an overview of the new veterinary regulation and its requirements, which includes the receipt and reporting of adverse event, pharmacovigilance system master file (PSMF), regulatory inspection, inclusion of new procedures in the quality management system, introduction of portals for the uploading of data including Union Product Database (UPD), EVVET, Union Pharmacovigilance Database and IRIS. There will be workshops and discussions for practical understanding of the concepts and regulatory requirements.

  •  Introduction to Veterinary Pharmacovigilance and its importance
  • Important definitions
  • Regulatory framework and applicable guidelines
  • Pharmacovigilance System Master file
  • Adverse events/safety reports for veterinary medicinal products and their reporting
  • Communication pathways and flow of safety reports
  • Safety evaluation and clinical trials for investigational veterinary medicinal products
  • Veterinary Dictionary for Drug Related Affairs (VeDDRA) terminology and its application for the reporting of suspected adverse events in animals and humans
  • Signal detection, Benefit versus risk evaluation and annual statement requirements
  • Volume of sales, its collection and reporting in the UPD
  • Quality Management System and Training
  • Electronic data uploading requirements in UPD, Union Pharmacovigilance Database and IRIS
  • Inspections, Audits and Third-Party Agreement
  • Communication, Record maintenance and Archive
  • UK VMR and EU Regulations
  • New graduates/beginners aiming to develop their career in veterinary pharmacovigilance.
  • Cross functional team members working in technical services, regulatory affairs, quality, compliance, sales and marketing, and customer services supporting or liaising with pharmacovigilance staff.
  • Experienced pharmaceutical professionals interested in enhancing their professional skills.

Participant experience
Life Science background is needed

Interactive training with presentation slides, interactive workshops and breakout sessions for discussion.

Docente/i
Jyoti Soni-Gupta
Info

Jyoti Soni-Gupta

Founder, ZIVA Health Regulatory Consultancy

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 | 10 December 2024 from 02:00 pm to 06:00 pm CET
Module 2 | 12 December 2024 from 02:00 pm to 06:00 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 19 November 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
Early bird
Acquistabile fino al 19/11/2024
895,00
Ordinaria
Acquistabile fino al 09/12/2024
1.095,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 09/12/2024
640,00
Svuota

Ilaria Butta
Ilaria Butta
Events & Training Manager
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the EU and UK veterinary pharmacovigilance regulatory framework.
Risultato atteso
Report and process adverse event in EVVET.
Risultato atteso
Know what is required for compliance maintenance with various pharmacovigilance obligations.
Risultato atteso
Knowledge of EU and VICH pharmacovigilance guidelines.
Risultato atteso
Understand the requirements of PSMF and quality management system.
Risultato atteso
Learn about the type of data required to be uploaded in the UPD, Union Pharmacovigilance Database and IRIS.
Risultato atteso
Preparation and reporting for pharmacovigilance inspection.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>