Seven Member States led the main SCOPE Work Packages and senior colleagues from each of these Member States comprised the Work Package Leaders group. Monthly teleconferences and regular face to face meetings were held, in order to share progress and raise any issues. The Work Package Lead Member States were responsible for all the other contributing Member States, with ultimate responsibility held by the UK as the project coordinator.
Work Package Leaders were involved in numerous Work Packages and responsible for leading topics within these.
INFARMED (National Competent Authority in Portugal) was Work Package Leader for Work Package 3 – Evaluation. Work Package 3 focused on Evaluation of the whole Joint Action, including delivery of training.
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HALMED (National Competent Authority in Croatia) was the leader of Work Package 4 – ADR collection, which focused on collection of Adverse Drug Reactions through spontaneous reporting systems, as well as the individual topics 4.1, 4.2 and 4.5
MEB (National Competent Authority of Netherlands) led on Work Package 5 – Signal detection, which improved understanding of best practice in signal management. The MEB is also leading topic 5.1
AEMPS, (National Competent Authority of Spain), headed Work Package 6 – Risk communications, considering communication of risk about medicines to healthcare professionals and patients. AEMPS is also led Topic 5.2
OGYÉI (National Competent Authority of Hungary), was Work Package 7 – Quality Management Systems lead and Topic 7.1 lead. This Work Package aimed to develop common quality standards in pharmacovigilance.
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AIFA, (National Competent Authority of Italy) led Work Package 8 – Pharmacovigilance Lifecycle, including individual Topics 8.1, 8.4 and 8.5, as well as Topic 6.3. Work Package 8 focused on the entire lifecycle of pharmacovigilance to support National Agencies in delivering exemplary standards throughout the product lifecycle; ensuring capability in performing high-quality assessments of, and giving advice on: risk management plans, post authorisation studies, periodic safety update reports, and referral procedures.
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The MHRA (National Competent Authority in the UK) ) coordinated the SCOPE Joint Action leading Work Package 1 – coordination, overall project management delivery, and effective communication of SCOPE’s aims, objectives, and progress through Work Package 2 – Dissemination. The MHRA was highly involved in individual Work Packages topics leading Topics 4.3, 4.4, 5.4, 6.4, 7.2 & 7.3.
