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.
Course | Detection of duplicates |
Description | The course provides a starting point for the development of a learning tool on duplicate detection processes specifically aimed at national competent authorities. |
Main topics discussed |
|
Learning materials |
Course | Additional monitoring |
Description | The course provides an introduction to additional monitoring, an insight into Member State experiences and examples of good practice from the United Kingdom's and Czechia's competent authorities. |
Main topics discussed |
|
Learning materials |
Course | Awareness levels of national ADR reporting systems |
Description | The course provides a strategy for NCAs to increase the number and quality of suspected ADR reports |
Main topics discussed |
|
Learning materials |
|
Course | Telephone reporting |
Description | The course provides guidance on how to handle patient telephone reporting, set up a telephone service and track the number and nature of the calls received. |
Main topics discussed |
|
Learning materials |
Course | Promoting ADR reporting |
Description | The course compares ADR reports from patients and healthcare professionals and provides tips on how to measure and improve the quality of reports in national ADR databases. |
Learning materials |
|
The SCOPE training: IT systems for ADR reporting: Best Practice Guide offers guidance for Member States to increase their knowledge of ADR IT systems and provides insight into existing IT systems and good practice in ADR reporting.
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.
Course | Introduction to signal management |
Description | The course gives an overview of best practice in signal management. |
Main topics discussed |
|
Learning materials |
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.
Course | Good practice guide on safety information for web portals |
Description | The course provides guidance on developing a useful and accessible platform for presenting safety information. It highlights important considerations in developing and optimising a web platform and presents case studies from national competent authorities. |
Main topics discussed |
|
Learning materials |
- SCOPE training: Risk communication on medicines: Proposals for improvement
- SCOPE training: Risk communication: Introduction
- SCOPE training: Risk communication on medicines: Report from the workshop
- SCOPE training: National strategy for implementation of recommendations on risk communication: Key actions
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.
Course | Introduction to quality management systems |
Description | The course provides basic knowledge of quality management and an understanding of how a quality management system can improve pharmacogivilance. |
Main topics discussed |
|
Learning materials |
Course | Exchange of information between pharmacovigilance assessors and inspectors |
Description | The course describes the types of marketing authorisation holder (MAH)-compliance information held by NCAs, how to access this information and the importance of information sharing between assessors and inspectors. |
Main topics discussed |
|
Learning materials |
Course | Quality planning and quality objectives |
Description | The course introduces the concepts of quality policies and quality planning and highlights the importance of setting and measuring objectives. It also covers internal communication strategies. |
Main topics discussed |
|
Learning materials |
Course | Resource management |
Description | The course introduces the concept of capacity management and highlights the importance of the recruitment, training and commitment of staff. It also considers factors that influence resource allocation. |
Main topics discussed |
|
Learning materials |
- SCOPE training: Document and records management
- SCOPE training: Quality management systems: Stakeholder feedback and customer satisfaction
- SCOPE training: Stakeholder feedback and customer satisfaction: Guidance and good practice examples
- SCOPE training: Survey report: Understanding National Quality 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.
Course | Assessment of Post-Authorisation Safety Studies (PASSs) |
Description | The course explains the concept of a PASS and provides an overview of the different types of PASS. |
Main topics discussed |
|
Learning materials |
Course | Assessment of periodic safety update reports (PSUR) and PSUR single assessments (PSUSA) |
Description | The course summarises certain key aspects to consider when undertaking a PSUR, PSUSA or referral assessment, including the objective, questions and outcomes. |
Main topics discussed |
|
Learning materials |
Course | Assessment of risk management plans |
Description | The course covers how to assess the various parts of a risk management plan, including the safety specification, missing information and the pharmacovigilance plan, and how to categorise risks. |
Main topics discussed |
|
Learning materials |
Course | Safety referrals assessed by the Pharmacovigilance Risk Assessment Committee (PRAC) |
Description | The course describes the various types of safety referrals procedure and the key stages in their assessment. It also provides tips on how to proceed when you are not (co)-rapporteur. |
Main topics discussed |
|
Learning materials |