Digital Learning Catalog
Excellence in Pharmacovigilance
This interactive training course is designed to provide a comprehensive understanding and overview of all key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.
This is the most anticipated Pharmacovigilance course of the year! For the past 12 years, the Excellence in Pharmacovigilance course has been the "go to" training for those who wished to enhance their knowledge in pharmacovigilance.
This edition of the Excellence in Pharmacovigilance training provides you with six modules, covering all topics, definitions and practical examples you need, to enhance your work in pharmacovigilance. The virtual live setting is a unique opportunity to react on individual demands and directly connect with your peers. Find your special area of interest below.
1 Nov 2021 8:30 AM – 2 Nov 2021 12:00 PM | Virtual Course
This introductory virtual live course includes a concise overview of the objectives and the scope of Pharmacovigilance. Get to know PV key definitions and understand basic methods with practical examples and exercises.
8 Nov 2021 8:30 AM – 9 Nov 2021 1:00 PM | Virtual Course
This module covers individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase. In this part of the training, case studies with practical examples will illustrate the PV post-marketing activities and processes.
11 Nov 2021 8:30 AM – 12 Nov 2021 1:00 PM | Virtual Course
With exemplificative case studies, this module provides an understanding of the safety reporting requirements, the roles and responsibilities of all stakeholders involved in clinical trials in line with the implementing texts and questions of safety data classification.
17 Nov 2021 8:30 AM – 18 Nov 2021 12:30 PM | Virtual Course
You will learn the key elements for establishing a quality system in Pharmacovigilance including aspects of the applicable GVP modules, preparing and conducting audits and inspections, as well as risk-based assessments, document management and PV agreements.
22 Nov 2021 8:30 AM – 23 Nov 2021 2:00 PM | Virtual Course
With Risk Management Plans (RMPs) companies propose activities aiming to identify, characterise or minimise risks associated with medicinal products. This module discusses examples on how to gain the necessary, robust data regarding potential public health implications and costs.
25 Nov 2021 8:30 AM – 26 Nov 2021 1:00 PM | Virtual Course
New safety signals may emerge at any time after product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. Learn about approaches to Signal Management using qualitative and quantitative methods, illustrated with examples and general considerations.