Pharmacovigilance training materials

The European medicines regulatory network has developed training materials, guidance, tools and templates to strengthen national pharmacovigilance systems and support Member States in the implementation of best practice. These materials are publicly available and can be useful for marketing authorisation holders, healthcare professionals, patient and consumer organisations and academia.

In November 2013, national competent authorities initiated the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action to support pharmacovigilance operations in the European network, minimise duplication of work and make the best use of work sharing and resources. The European Medicines Agency (EMA) was a member of the project's General Advisory Board.

SCOPE developed training modules and best practice guides in key areas of pharmacovigilance for staff working at national competent authorities to further improve their skills and the capability of the EU pharmacovigilance network. SCOPE published the training materials in 2016.

The SCOPE website was decommissioned following project closure and EMA agreed to make the training materials available on its website. Stakeholders can use these publicly-available training materials, tools and templates to learn about best practice in pharmacovigilance and strengthen their pharmacovigilance systems.

The EU Network Training Centre (EU NTC), a joint training initiative established by the Heads of Medicines Agencies (HMA) and EMA, uses SCOPE learning materials to train assessors.

Users should bear in mind that the file size of some documents exceeds 30 megabytes.

Collection of adverse drug reactions

These training materials focus on national schemes for the spontaneous reporting of adverse drug reactions (ADRs) by healthcare professionals and patients. They aim to provide national competent authorities (NCAs) with a better understanding of available systems and practices for collecting ADRs.

Signal management

These training materials seek to further improve understanding of signal management within the European medicines regulatory network and develop best practice in signal management.

Risk communication

These training materials focus on risk communication practices in the EU medicines regulatory network, including the various communication channels and tools used and the effectiveness of different strategies and methods.

Quality management systems

These training materials aim to increase existing knowledge on quality management systems and to help develop tools to support quality standards and best practice in pharmacovigilance systems.

Life-cycle pharmacovigilance

These training materials explore the standards for pharmacovigilance assessments and examine the availability and use of data sources other than spontaneous reports in different national competent authorities.

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