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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.

  • Introduction to "Excellence in Pharmacovigilance"

    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.

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  • Module 1: Post-Marketing

    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.

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  • Module 2: Safety Aspects in Clinical Trials

    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.

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  • Module 3: Quality Management System

    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.

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  • Module 4: Risk Management

    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.

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  • Module 5: Signal Management

    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.

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