Table 2.

SCOPE Joint Action results and outputs, including e-learning modules

ADR collection (WP4)	ADR reporting
	An active approach to comparisons of adverse drug reaction reports from patients and healthcare professionals
	Collaboration with patient organisations to promote and support patient ADR reporting
	Duplicate detection: best practice guidance
	Duplicate detection (e-learning)
	Feedback to patient ADR reports
	Identification, management and raising awareness of ADR reports for drugs subject to additional monitoring
	The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) WP4—additional monitoring (e-learning)
	Medication errors
	Tools for measuring and improving the quality of reports in national adverse drug reaction databases
	Awareness levels
	Adverse drug reactions: reporting makes medicines safer (e-learning for HCPs)
	Increasing awareness of national adverse drug reaction reporting systems: best practice guide
	Raising and measuring awareness levels for ADR reporting systems through campaigns and regional monitoring centres
	Raising awareness of national ADR reporting systems: case studies by country
	Strategy guidance for increasing awareness levels of national ADR reporting systems (e-learning)
	Reporting tools
	Handling telephone calls from the public
	The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) WP4—telephone reporting (e-learning)
	Paper ADR reporting forms
	IT systems
	IT systems for ADR reporting: best practice guide
	Survey reports
	SCOPE Work Package 4 Survey Report Topic 1—audit of national reporting systems; 1a Medication errors, 2 Patient reporting, 5 Review of IT systems and special form of reports
	Increasing awareness of national adverse drug reaction reporting systems: survey report
	SCOPE Work Package 4 Survey Report Topic 4—review of reporting forms
Signal management (WP5)	Signal management best practice guide
	Introduction to signal management (e-learning)
	WP5—literature review on signal management
	SCOPE Work Package 5—survey report
Risk communications (WP6)	Introductory document
	Proposals for improvement
	Web-based safety information
	Risk communication on medicines: report from the workshop (16–17 June 2016)
	National strategy for implementation of recommendations on risk communication: key actions
	Survey reports and consultations
	SCOPE Work Package 6 Survey Report—audit of national methods of communication
	SCOPE Work Package 6 Survey Report—web portals
	Healthcare Professional Survey—medicines safety communications and their effectiveness
	Patient and consumer consultation
	Publications
	Communication on safety of medicines in Europe: current practices and general practitioners’ awareness and preferences, drug safety
	Safety communication tools and healthcare professionals’ awareness of specific drug safety issues in Europe—a survey study, drug safety
Quality management systems (WP7)	Introduction to quality management systems (e-learning)
	Compliance and performance: management and indicators
	Document and records management
	Exchange of information between PV assessors and PV inspectors: best practice guidance
	Good practice in the exchange of information between pharmacovigilance assessors and pharmacovigilance inspectors within NCAs (e-learning)
	Pharmacovigilance quality manual template
	Quality planning and quality objectives
	Quality management systems: quality planning and quality objectives (e-learning)
	Quality standards of pharmacovigilance assessment
	Resource management best practice guidance
	Resource management best practice (e-learning)
	Stakeholder feedback and customer satisfaction
	Stakeholder feedback and customer satisfaction: guidance and good practice examples (interactive pdf)
	Survey reports
	Survey report: understanding national quality systems
	Survey report: resource management
	Survey report: interaction with pharmacovigilance inspectors
Lifecycle pharmacovigilance (WP8)	Competency
	Competency recommendations
	Available data sources outside spontaneous reports
	Identification of available data sources outside spontaneous reports: recommendations
	PASS
	PASS recommendations
	Practical guide on PASS assessment
	PASS assessment (e-learning)
	PSUR/PSUSA
	PSUR/PSUSA and referral recommendations
	Practical guide on PSUR/PSUSA assessment
	Periodic Safety Update Report (PSUR) assessment (e-learning)
	RMPs
	Risk management plan recommendations
	Practical guide on risk management plan assessment
	Risk Management Plan (RMP) Assessment (e-learning)
	Safety-related referrals
	Practical guide on safety-related referrals
	Top 10 tips on safety-related referrals
	Safety referrals e-learning: practical guidance for assessors (e-learning)
	Survey reports
	SCOPE Work Package 8—lifecycle pharmacovigilance executive summary report

The SCOPE website will continue to be live until the end of 2019. Therefore, links in this table may not be accessible from January 2020 but will continue to be available via the EU Network Training Centre and the CHAFEA project database

ADR adverse drug reaction, CHAFEA Consumers, Health, Agriculture and Food Executive Agency, HCPs healthcare professionals, IT information technology, PASS post-authorisation safety and efficacy studies, PSUR periodic safety update reports, PSUSA single assessment of periodic safety update reports, PV pharmacovigilance, RMP risk management plan, WP work package