Pharmacovigilance training materials

Collection of adverse drug reactions
Signal management
Risk communication
Quality management systems
Life-cycle pharmacovigilance

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	Management of duplicates and examples of good practice Importance of duplicate detection and key points of the process Guidance on the detection of duplicates
Learning materials	Detection of duplicates: e-learning course SCOPE training: Duplicate detection best practice guide (PDF/1.75 MB)

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	Importance of additional monitoring Identifying, managing and raising awareness of ADRs for drugs subject to additional monitoring Examples to optimise processes for tracking and handling of ADRs for drugs subject to additional monitoring
Learning materials	Additional monitoring: e-learning course SCOPE training: Identification, management and raising awareness of ADR reports for drugs subject to additional monitoring (PDF/1.93 MB)

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	Strategy to increase ADR awareness levels Importance of focussing resources, stakeholder analysis and benchmarking. Four pillars to raise awareness of national ADR reporting systems Suggestions on how to increase ADR awareness levels Running an ADR campaign Measuring success
Learning materials	Awareness levels of national ADR reporting systems: e-learning course SCOPE training: Increasing awareness of national adverse drug reaction reporting systems: Best practice guide (PDF/58.3 MB) SCOPE training: Measuring awareness levels through campaigns and regional monitoring centres (PDF/55.8 MB) SCOPE training: Raising awareness of National Adverse Drug Reaction Reporting Systems: Case Studies by Country (PDF/39.4 MB)

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	Benefits of offering a telephone reporting service Types of calls received Writing down the details of an ADR report Handling a range of calls
Learning materials	Telephone reporting: e-learning course SCOPE training: Handling telephone calls from the public (PDF/1.4 MB) SCOPE training: Paper ADR reporting forms (PDF/4 MB)

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	SCOPE training: Active approach to comparisons of ADR reports from patients and healthcare professionals (PDF/2.14 MB) SCOPE training: Collaboration with patient organisations to promote and support patient ADR reporting (PDF/5.9 MB) SCOPE training: Feedback to patients on their ADR reports (PDF/1.74 MB) SCOPE training: Medication errors (PDF/1.72 MB) SCOPE training: Tools for measuring and improving the quality of reports in national adverse drug reaction databases (PDF/2.88 MB)

: The Best practice guide on IT systems for adverse drug reporting (ADR) 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	Five steps in signal management: detection, prioritisation, validation, confirmation and assessment. Most relevant sources of information used in signal management Reports of special interest
Learning materials	Signal management: e-learning course SCOPE training: Signal Management Best Practice Guide (PDF/1.57 MB)

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	Introduction: knowing your audience, technical and resource considerations, legal requirements, etc Compliance with minimum requirements: Directive 2010/84/EU, Good practice case studies, additional considerations Presenting safety information: language style, information architecture, search functions, layout of individual webpages, etc Additional tools and case studies: knowing your audience, national considerations, quality control, raising awareness and new platforms going forward.
Learning materials	SCOPE training: Good practice guide on safety information for web-portals (PDF/10.4 MB)

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	A brief history of quality management Pharmacovigilance systems Quality systems processes
Learning materials	Introduction to quality management systems: e-learning course SCOPE training: Pharmacovigilance quality manual template (PDF/37.10 MB) SCOPE training: Quality standards of pharmacovigilance assessment (PDF/1.32 MB)

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	Types of MAH-compliance information How to access MAH-compliance information Sharing information Use of checklists
Learning materials	Exchange of information between pharmacovigilance assessors and inspectors: e-learning course SCOPE training: Exchange of information between PV assessors and PV inspectors: best practice guidance (PDF/2.65 MB) SCOPE training: Interaction with pharmacovigilance inspectors: survey report (PDF/4.2 MB)

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	Quality plans Planning process and levels: from strategy to individual employees How to define quality objectives and link them to the quality policy Relationship between quality objectives and indicators Internal communication of strategies, quality policy and objectives
Learning materials	Quality planning and quality objectives: e-learning course SCOPE training: Quality planning and quality objectives (PDF/2.37 MB) SCOPE training: Compliance and performance: management and indicators (PDF/1.9 MB)

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	Capacity management Recruitment, training / development and commitment of staff Resource allocation
Learning materials	Resource management: e-learning course SCOPE training: Resource management best practice guidance (includes case studies) (PDF/15.10 MB) SCOPE training: Resource management survey report (PDF/4.37 MB)

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	Description of a PASS Different types of PASS Tools available to help with the assessment of a PASS.
Learning materials	Assessment of Post-Authorisation Safety Studies (PASSs): e-learning course SCOPE training: PASS Recommendations (PDF/3.24 MB) SCOPE training: Practical guide on PASS assessment (PDF/1.9 MB)

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	Purpose of PSUR assessment Approaches in the assessment of a PSUR Challenges of key aspects of PSUR assessment
Learning materials	Assessment of periodic safety update reports (PSUR) and PSUR single assessments (PSUSA): e-learning course SCOPE training: PSUR-PSUSA and referral recommendations (PDF/4.55 MB) SCOPE training: Practical guide on PSUR/PSUSA assessment (PDF/1.61 MB)

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	Important risks regarding the benefit/risk of the product Categorising important risks as identified risks or potential risks How to identify patient groups for which there is missing safety information Additional pharmacovigilance activities and related activities Additional risk minimisation measures and related activities.
Learning materials	Assessment of risk management plans: e-learning course SCOPE training: Risk management plan recommendations (PDF/3 MB) SCOPE training: Practical guide on risk management plan assessment (PDF/1.62 MB)

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	Purpose of a safety referral Types of referral procedures Key stages in a referral and how to prepare for them Steps in the assessment process and drafting high quality assessment reports
Learning materials	Safety referrals assessed by the PRAC: e-learning course SCOPE training: Practical guide on safety-related referrals (PDF/1.66 MB)

Topics

Pharmacovigilance