2026-02-12 2026-02-12 , online online, 2,090 € zzgl. MwSt. An Introduction for Pharmacovigilance Managers

This intensive two-day online course offers a concise yet comprehensive overview of all core elements of pharmacovigilance, including EU regulatory requirements and their practical implementation. It is ideal for professionals who need a clear, structured understanding of the full range of pharmacovigilance activities.

Themen
  • Regulatory framework and EMA GVP modules
  • Management of side effects and signals
  • Benefit-risk assessment and risk management
  • Important pharmacovigilance documents
  • Interfaces with other departments and quality management


Who should attend
This course will be conducted in English.

This online course is designed for professionals who need a clear and compact overview of all key pharmacovigilance activities. It is suitable for those at an early stage of their drug safety career as well as for experts from related areas who wish to broaden or refresh their knowledge of the full pharmacovigilance system. It is particularly relevant for staff working in
  • drug safety, patient safety, pharmacovigilance,
  • quality management, clinical research, medical affairs and regulatory affairs,
  • as well as for graduates in medicine or life sciences who are moving into these functions
Ziel der Veranstaltung
This online course provides comprehensive knowledge on all the essentials of pharmacovigilance over two days. It equips participants with the necessary tools to confidently fulfil their responsibilities in the various aspects of pharmacovigilance.

The course will enable you to:
  • Describe the mechanisms of pharmacovigilance in Europe.
  • Classify information on adverse drug reactions including MedDRA coding.
  • Properly assess the responsibilities of pharmacovigilance officers.
  • Understand the significance of pharmacovigilance and risk management systems.
  • Comply with risk assessment procedures.
Teilnehmerkreis

This foundational course offers a comprehensive overview of pharmacovigilance, providing you with essential knowledge from both a regulator's and industry perspective.

In addition, the training contains many interactive parts to break up the training and deepen the learning. The quiz and the workshops "Individual causality assessment" and "Risk minimisation measures and risk communication" reinforce the theoretical content and teach you how to put knowledge into practice. The final workshop, "Drug safety in the life cycle of a drug", gives you the opportunity to consolidate what you have learned.

This course will helps you to better navigate the diverse responsibilities within drug safety and leads to a qualified certificate.

Online Course - An Introduction for Pharmacovigilance Managers

An Introduction for Pharmacovigilance Managers

Core Concepts of Drug Safety

Benefits
  • Condensed overview of pharmacovigilance
  • Delivered by two PV experts with different professional backgrounds
  • Interactive format
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 26102050

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JETZT Buchen

Alles auf einen Blick

Termin

07 - 08/10/2026

07 - 08/10/2026

Zeitraum

Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts

Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

This intensive two-day online course offers a concise yet comprehensive overview of all core elements of pharmacovigilance, including EU regulatory requirements and their practical implementation. It is ideal for professionals who need a clear, structured understanding of the full range of pharmacovigilance activities.

Themen

  • Regulatory framework and EMA GVP modules
  • Management of side effects and signals
  • Benefit-risk assessment and risk management
  • Important pharmacovigilance documents
  • Interfaces with other departments and quality management


Who should attend
This course will be conducted in English.

This online course is designed for professionals who need a clear and compact overview of all key pharmacovigilance activities. It is suitable for those at an early stage of their drug safety career as well as for experts from related areas who wish to broaden or refresh their knowledge of the full pharmacovigilance system. It is particularly relevant for staff working in
  • drug safety, patient safety, pharmacovigilance,
  • quality management, clinical research, medical affairs and regulatory affairs,
  • as well as for graduates in medicine or life sciences who are moving into these functions

Ziel der Veranstaltung

This online course provides comprehensive knowledge on all the essentials of pharmacovigilance over two days. It equips participants with the necessary tools to confidently fulfil their responsibilities in the various aspects of pharmacovigilance.

The course will enable you to:

  • Describe the mechanisms of pharmacovigilance in Europe.
  • Classify information on adverse drug reactions including MedDRA coding.
  • Properly assess the responsibilities of pharmacovigilance officers.
  • Understand the significance of pharmacovigilance and risk management systems.
  • Comply with risk assessment procedures.

Teilnehmerkreis

This foundational course offers a comprehensive overview of pharmacovigilance, providing you with essential knowledge from both a regulator's and industry perspective.

In addition, the training contains many interactive parts to break up the training and deepen the learning. The quiz and the workshops "Individual causality assessment" and "Risk minimisation measures and risk communication" reinforce the theoretical content and teach you how to put knowledge into practice. The final workshop, "Drug safety in the life cycle of a drug", gives you the opportunity to consolidate what you have learned.

This course will helps you to better navigate the diverse responsibilities within drug safety and leads to a qualified certificate.