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Recognising Adverse Drug Reactions

Objective

WEB-RADR is a consortium of leading experts in pharmacovigilance from regulatory agencies, research, academia and patient support groups. Together with EFPIA partners our aims will be to set policy & guidance and deliver robust information technology tools to address the potential for the reporting of adverse drug reactions (ADRs) through mobile applications and the recognition of drug safety signals from user comments in social media and the internet. The policies, guidance and tools delivered through WEB-RADR will be underpinned by extensive academic research and user testing to ensure the project meets the needs of all stakeholders, including patients.

Background
Reporting by healthcare professionals and patients by means of mobile devices and social media platforms to National Competent Authorities (NCAs) and marketing authorisation holders with subsequent transmission to EudraVigilance is a new, unexplored concept. The amount of information generated through social media requires a structured, scientific approach for monitoring, reporting, analysing and evaluation of ADRs. Whilst there are numerous benefits of the use of social media, the impact on healthcare professionals and patients and their behaviour towards the use of medicines needs to be further analysed. WEB-RADR will address these areas.

Leadership
WEB-RADR will be managed by the MHRA’s project management team that are also leading the EC Joint Action (Strengthening Collaborations for Operating Pharmacovigilance in Europe, SCOPE). This will enable the alignment and consistency of the two projects. The MHRA has extensive experience in managing successful pharmacovigilance and IT projects (E2B compliant web-forms for ADR reporting; integration with EudraVigilance; drug and medical dictionary mapping; integration with NHS electronic health records) as well as being a leading regulatory agency, helping to shape the current legislative framework.
Establishing clear policies and guidance for stakeholders in the use of these technologies, in line with legislative requirements, is of paramount importance to regulators and industry. The EMA will provide leadership in this area, supported by colleagues from MHRA, HALMED & LAREB. As the central regulatory agency for medicines policy in the EU it is natural for the EMA lead in this area as the outputs of WEB-RADR will have a direct bearing on future operations affecting EudraVigilance, Good Vigilance Practice (GVP) guidance, signal detection and risk communication. Expertise from a national perspective together with EFPIA input will also be essential.

Technical Platform
The development of technical platforms for both the reporting of ADRs via a mobile application and recognising drug safety issues from social media will be led by Epidemico who already offer a number of products through an ongoing partnership with the FDA. Working with SRDC and EFPIA sponsors, WEB-RADR will produce an online dashboard and data feed of data identifying ADRs from social media in multiple languages. A mobile app for direct reporting of ADRs to national authorities in E2B(R2) Individual Case Safety Report compatible format will be developed. To achieve this we propose to expand the prototype MedWatcher Social platform to include social media monitoring in the EU and the MedWatcher App for reporting ADRs.

Analysis
Led by UMC and working with SRDC, WEB-RADR will ensure the technical platform for gathering drug safety data from social media delivers meaningful and useable data in the EU pharmacovigilance setting. It is essential that data collected use standardised drug, product and medical terms. Mapping of the terms to ensure compatibility with EudraVigilance and NCA databases will be carried out so that terms in the Article 57 database and MedDRA are the basis for analysis. It is essential to detect and manage duplicate reports. A major effort in WEB-RADR will be the advancement of new methodologies to meet this challenge. UMC h

Call for proposal

IMI-JU-09-2013
See other projects for this call

Coordinator

NOVARTIS PHARMA AG
Address
Lichtstrasse 35
4056 Basel
Switzerland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Principal investigator
David Lewis (Dr.)
Administrative Contact
Barbara Stolz (Dr)

Participants (18)

Department of Health
United Kingdom
EU contribution
€ 330 342
Address
Quarry House, Quarry Hill
LS2 7UE Leeds
Activity type
Research Organisations
Administrative Contact
Mick Foy (Mr)
Epidemico Limited
Ireland
EU contribution
€ 519 335
Address
Rbk House
ATHLONE Irishtown
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Robin Heffernan (Chief Operating Officer)
EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
France
EU contribution
€ 80 475
Address
Rue Didot 96
75014 Paris
Activity type
Other
Administrative Contact
Patrice Regnier (Mr)
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 100 526
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Johanna, M Van Apeldoorn (Dr)
THE UNIVERSITY OF LIVERPOOL
United Kingdom
EU contribution
€ 276 548
Address
Brownlow Hill 765 Foundation Building
L69 7ZX Liverpool
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Jenny Lawson (Miss)
SRDC YAZILIM ARASTIRMA VE GELISTIRME VE DANISMANLIK TICARET ANONIM SIRKETI
Turkey
EU contribution
€ 75 000
Address
Silikon Bina 1 Kat No 14 Odtu Teknokent Cankaya
06800 Ankara
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Asuman Dogac (Prof. Dr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
EU contribution
€ 112 500
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kamila Kolasinska (Ms)
AGENCIJA ZA LIJEKOVE I MEDICINSKE PROIZVODE
Croatia
EU contribution
€ 49 374
Address
Ksaverska Cesta 4
10 000 Zagreb
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Goranka Marušić Kontent (L.L.M.)
STICHTING LAREB
Netherlands
EU contribution
€ 138 249
Address
Goudsbloemvallei 7
5237 MH S Hertogenbosch
Activity type
Research Organisations
Administrative Contact
Linda Härmark (Dr)
THE EUROPEAN MEDICINES AGENCY
Netherlands
EU contribution
€ 246 878
Address
Domenico Scarlattilaan 6
1083 HS Amsterdam
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Victoria Newbould (.)
Stiftelsen WHO Collaborating Centre for International Drug Monitoring
Sweden
EU contribution
€ 340 773
Address
Bredgrand 7
S-75140 Uppsala
Activity type
Research Organisations
Administrative Contact
Birgitta Toreheim (Ms)
JANSSEN PHARMACEUTICA NV
Belgium
Address
Turnhoutseweg 30
2340 Beerse
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
koen Meeussen (MR)
Bayer Pharma AG
Germany
Address
Muellerstrasse 178
13353 Berlin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Petra Freitag (Ms)
ASTRAZENECA AB
Sweden
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Eva Lindgren (Senior Director)
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Laurence Mazuranok (Ir.)
UCB BIOPHARMA
Belgium
Address
Allee De La Recherche 60
1070 Bruxelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon Dresse (Mr)
AMGEN
Belgium
Address
Telecomlaan 5-7
1831 Diegem
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Simon Gibbs (Senior Project Manager)
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.
United Kingdom
Address
Great West Road 980
TW89GS Brentford
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Sally Miles (-)