EudraVigilance auditable requirement project: ADRreports.eu portal update Patients and Consumers Working Party – 30 th November 2016 An agency of the European Union Francois Domergue, Business project manager
Content Summary ADR project context and status Introduction to the ADRreports.eu portal Portal enhancements and Use Cases Next Steps 1
Content Summary ADR project context and status Introduction to the ADRreports.eu portal Portal enhancements and Use Cases Next Steps 2
Content Summary ADR project context and status Introduction to the ADRreports.eu portal Portal enhancements and Use Cases Next Steps 3
EV ADR Project Scope In December 2013, the EMA Management Board endorsed the “EudraVigilance Auditable requirem ents” : Sim plified reporting of side effect reports for MAHs with re-routing to NCAs Provision of reports to W HO (respecting EU data protection legislation) EV access for MAHs to conduct product monitoring including signal detection (respecting EU data protection legislation) Publication of data and search availability for healthcare professionals and the public for all m edicines authorised in the EU Com pliance w ith international I CSR standards Conversion of legacy data ( > 1 0 m ill. I CSRs currently held in EV) System perform ance and scalability based on increased number of users and volume of data Security (authentication, authorisation and data transaction to limit the risks of unauthorised access) 4
EV ADR Project Timelines • The ‘ EudraVigilance Auditable Requirem ents Project ’ was set-up to deliver the new EV system . • Before the move to simplified reporting, the new EudraVigilance system has to undergo an independent audit against the functionalities agreed with the EMA Management Board in December 2013. • To further strengthen system performance ahead of its launch, in June 2016, the EMA Managem ent Board approved an updated schedule: Final release of elearning m odules / user m anuals Jan 2 0 1 7 I ndependent audit of new EudraVigilance system Feb 2 0 1 7 PRAC recom m endation on final audit report May 2 0 1 7 EMA Managem ent Board adoption of final audit outcom e – May 2 0 1 7 Final audit report to be presented for adoption by written procedure, supported if needed by a dedicated Management Board teleconference Release of new EudraVigilance functionalities – Including Nov 2 0 1 7 adoption of revised Access Policy, and the move to simplified reporting. 5
Content Summary ADR project context and status Introduction to the ADRreports.eu portal Portal enhancements and Use Cases Next Steps 6
ADRreports.eu portal context The European Medicines Agency (EMA) plays a key role in the safety m onitoring of m edicines in the European Union ( EU) - this is known as pharmacovigilance. The Agency’s main role in this area is to support the coordination of the European pharm acovigilance system and to provide advice on the safe and effective use of m edicines. As part of this responsibility, the Agency is responsible for the developm ent, m aintenance and co-ordination of EudraVigilance , a system for reporting suspected cases of adverse reactions to a medicine. Data from EudraVigilance are published in the European database of suspected adverse drug reaction reports. ( ADRreports.eu portal) . • Since May 2012, this portal allows users to view the total number of individual suspected side effect reports (also known as Individual Case Safety Reports, or ICSRs) submitted to EudraVigilance for each centrally authorised medicine. Users can view these reports by age group, sex, type of suspected side effect and outcome. • Since October 2014, reports for common drug substances used in nationally authorised medicines are available. 7
ADRreports.eu portal structure The information on the portal relates to suspected side effects , i.e. medical events that have been Information on suspected side observed following the use of a effects should not be interpreted as medicine, but which are not meaning that the medicine or the necessarily related to or caused by active substance causes the observed the m edicine . effect or is unsafe to use. Normally carried our by healthcare professionals. Patients can report adverse reactions through their A browsing tab will appear allowing national competent authorities you to select data for a specific product or substance The European Medicines Agency publishes this data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency. 8
How can I use the portal? View suspected View suspected ADR View suspected ADR ADR reports for reports by age, sex, reports for products geography substances (brand names) (scientific name) Drug safety Patients ( or experts There are a num ber of w ays in w hich the patient’s behalf) ADRreports.eu portal could be used Healthcare Professionals View suspected ADR reports over Download reports View number of time using the line Compare data for cases by reaction listing tab different products & or reaction group substances 9
Availability of information The follow ing inform ation can be accessed through the ADRreports.eu portal w eb reports: • Aggregated data outputs based on predefined queries • I ndividual Case Safety Report ( I CSR) line listings (based on core ICSR data elements) • I CSR form s (for individual case review) 10
Content Summary ADR project context and status Introduction to the ADRreports.eu portal Portal enhancements and Use Cases Next Steps 11
ADRreports.eu portal enhancements • As of November 2017, the ADRreports.eu portal contains 3 additional tabs providing enhanced functionality relative to the current implementation. • These enhancem ents w ill allow the general public to: View the number of cases received over time View the number of cases received in a particular geography Download data using various criteria (age, sex, time, geography) in an excel file for further analysis 12
Web report structure 1 . Num ber of individual cases 2 . Num ber of 7 . Line listing individual cases received over tim e New ! New ! Each report w ill contain 7 tabs w ith different data view s 6 . Num ber of 3 . Num ber of individual cases individual cases by for a selected EEA countries New ! reaction 5 . Num ber of 4 . Num ber of individual cases individual cases by for a selected reaction groups reaction group 13
Web report functionality Num ber of individual cases 1 . Num ber of individual cases • Displays the running total of individual cases split age group, 2 . Num ber of sex, and geographic origin. individual cases 7 . Line listing received over New ! tim e New ! • Running total of cases identified in Each report w ill contain 7 tabs EudraVigilance up to the end of w ith different data view s the previous month is displayed. 6 . Num ber of 3 . Num ber of individual cases individual cases for a selected by EEA countries reaction New ! 5 . Num ber of 4 . Num ber of individual cases individual cases for a selected by reaction reaction group groups 14
Web report functionality Num ber of individual cases 1 . Num ber of received over tim e individual cases • Displays the number of individual 2 . Num ber of cases received over the last 12 individual cases 7 . Line listing received over New ! tim e months split by geographic origin New ! Each report w ill (cases that arose in EEA countries contain 7 tabs w ith different vs those that occurred outside the data view s 6 . Num ber of 3 . Num ber of EEA). individual cases individual cases for a selected by EEA countries reaction New ! • A new addition to the ADRreports.eu portal that w ill 5 . Num ber of 4 . Num ber of be im plem ented in 2 0 1 7 . individual cases individual cases for a selected by reaction reaction group groups 15
Web report functionality Num ber of individual cases 1 . Num ber of by EEA countries individual cases • Displays the number of individual 2 . Num ber of cases in each European Economic individual cases 7 . Line listing received over New ! Area country for the selected tim e New ! Each report w ill medicinal product. contain 7 tabs w ith different data view s • A new addition to the 6 . Num ber of 3 . Num ber of individual cases individual cases ADRreports.eu portal that w ill for a selected by EEA countries reaction New ! be im plem ented in 2 0 1 7 . 5 . Num ber of 4 . Num ber of individual cases individual cases for a selected by reaction reaction group groups 16
Web report functionality Num ber of individual cases 1 . Num ber of by reaction groups individual cases • Displays a graph that visualises 2 . Num ber of the number of individual cases per individual cases 7 . Line listing received over New ! tim e MedDRA reaction group New ! Each report w ill contain 7 tabs • Results can be split by one other w ith different data view s variable (age group / sex / 6 . Num ber of 3 . Num ber of individual cases individual cases seriousness / reporter group / for a selected by EEA countries reaction New ! geographic origin). 5 . Num ber of 4 . Num ber of individual cases individual cases for a selected by reaction reaction group groups 17
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