The WEB-RADR 2 Stakeholder Event will take place on Thursday 26 March 2020.
The one-day Stakeholder Event will showcase WEB-RADR 2 Work Package outputs, promote project sustainability, and display the fantastic collaborative work achieved over the 18-month exploitation project.
Further details about the event, including the link to register can be found on the events page.
The Med Safety app was launched in Ivory Coast on 17 December 2019. The launch was made possible due to collaborative efforts between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and DMPL.
The Med Safety app was launched in Botswana on 14 November 2019. The launch was made possible due to collaborative efforts between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and Botswana Medicines Regulatory Authority (BOMRA).
The Med Safety app was launched in Ethiopia on 23 September 2019. The launch was made possible due to collaborative efforts between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and the Ethiopian Food and Drug Administration (EFDA).
The Med Safety app was launched in Ghana on 25 June 2019. The launch was made possible due to collaborative efforts between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and Ghanaian Food and Drugs Authority (FDA).
The Med Safety app was launched in Armenia on 7 May 2019. The launch was made possible due to collaborative efforts between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and the Armenian Scientific Centre of Drug and Medical Technology Expertise (SCDMTE).
Social media can offer opportunities in pharmacovigilance by providing interactive platforms as well as access to large and real-time datasets, although it should be acknowledged that WEB-RADR (Web-Recognising Adverse Drug Reactions) results indicate limited value in detecting signals.
A key challenge is obtaining clarity on the regulatory requirements that arise in using social media such as the processing and reporting of safety information.
Principles for the use of social media in pharmacovigilance are put forward that take into account existing legal requirements and the need to provide continuous monitoring of the safety of medicines.
The WEB-RADR Team has published ‘Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR’ in Drug Safety.
A mobile application (app) designed for adverse drug reaction (ADR) reporting and product safety alerts can help to augment pharmacovigilance activities and extend a health authority’s reach to patients and healthcare professionals.
Of particular value to app users was the ability to learn about the safety profiles of medicines through user-friendly, interactive graphics within the app as well as privacy and data protection features.
While uptake and use of the app to date seems modest in comparison with other ADR-reporting modalities, it is reasonable to expect that app-based reporting will grow in importance as a younger generation of app-literate patients matures and smartphone owners increasingly use their mobile devices to access the Internet.
The WEB-RADR 2 project held its kick off teleconference on 28th September 2018.
The teleconference well attended, with all organisations participating. This meeting provided an opportunity for background information on the original WEB-RADR project to be shared as well as activities planned for the new WEB-RADR 2 project.
The WEB-RADR Stakeholder Event will be held in London on Thursday 7th September 2017.
The one day event will provide an overview of WEB-RADR’s outputs and its contribution to the safeguarding of public health within the European Union network and beyond. The event will also serve as a forum for exchange of views and ideas for building on the future of pharmacovigilance in the digital age, and promote the mechanism by which the project deliverables will be sustained.
For further information about the event, and to register your interest please see Eventbrite.
The WEB-RADR app was launched in Zambia on 29 June 2017. The launch was made possible through collaboration between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and ZAMRA (Zambia Medicines Regulatory Autority).
The WEB-RADR app was launched in Burkina Faso on 15 June 2017. The launch was made possible through collaboration between IMI, WEB-RADR, the World Health Organisation (WHO), the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC), and the DGPML (Direction Générale de la Pharmacie, du médicament et des laboratoires).
The report from the second Innovative Medicines Initiative (IMI) WEB-RADR Work Package 1 workshop has been published.
The workshop, which took place on 19 October 2016, focused on the evaluation of the use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR), and the usefulness of social media data for pharmacovigilance.
The workshop informed about developments and outputs from the project, and dedicated breakout sessions allowed participants to focus on specific topics of interest. These will inform the final deliverables of providing recommendations for policy and governance for mobile device and social media use for a pharmacovigilance landscape into the future.
This work will inform the development of a future policy framework on the further use of social media as a new pharmacovigilance data source in the European Economic Area. In addition, this paper elaborates on some current practical case management issues encountered by companies based on the existing regulatory guidance.
The WEB-RADR Work Package 3B team has published their findings from a qualitative study investigating the factors influencing the use of a mobile app for two-way risk communication. The results of the study will be of interest to pharmacovigilance experts, and app researchers and developers and will be used to improve WEB-RADR’s mobile apps.
The ‘Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study’ publication is in Drug Safety can be found here.
Key points (as highlighted in the article):
Factors influencing the use of an app for two-way risk communication concern what feedback would be given on adverse drug reaction reports and how safely these are stored and handled; what type of news, if any, would be provided through the app; other functions of the app; ease of use; the source (authority) behind the app; appropriate language and appeal of the app; and costs.
User characteristics (e.g. age, education, experience with apps) may moderate to what extent specific factors (e.g. functions, security) influence use of the app.
When designing or improving an app for two-way risk communication, pharmacovigilance experts, and app researchers and developers should consider the identified factors.
Ongoing research focuses on the quantification of the influencing factors and on associations between user characteristics and the direction of the influencing factors.
The WEB-RADR Work Package 1 (Government and Policy) organised a second workshop on 19th October 2016 at the European Medicines Agency, to discuss the use of mobile technologies and social media as new tools to generate evidence for the monitoring of the safety of medicines.
The aim of the workshop was to engage with consumers, patients, healthcare professionals and medicines regulatory authorities to discuss latest developments and to obtain input and feedback to maximise the utility and benefits of the project deliverables.
The day consisted of three sessions.
Session 1: WEB-RADR: where we have come from and what we have achieved
Session 2: How to optimise WEB-RADR deliverables
Session 3: Breakout sessions WEB-RADR
Patients and healthcare professionals – what do we want as WEB-RADR outputs?
Regulatory questions – what are the options?
How could social media monitoring support signal detection?
How to ensure future maintenance and sustainability of WEB-RADR?
The day was a great success and provided a platform for attendees to share their views and expectations to maximise the outputs of WEB-RADR in strengthening pharmacovigilance.
A workshop report will be completed summarising the day’s presentation and discussion topics.
Work Package 3B of the WEB-RADR project has launched two surveys, for healthcare professionals and for patients and consumers of medicines, to determine opinions about a mobile app which can be used to report adverse drug reactions (ADRs) and to receive safety information about medicines.
The results of the survey will be used to improve WEB-RADR’s mobile apps, and to increase general knowledge about mobile two-way communication; the reporting of ADRs and availability of news and safety alerts about particular medicines.
Completing the survey is anonymous and will take approximately 15-20 minutes. The surveys are available in seven languages; Croatian, Dutch, English, French, German, Portuguese and Spanish.
Please follow the below links to the surveys or see Twitter posts of @WEBRADR. The surveys will close early September 2016.
The final WEB-RADR app was launched on 18 May 2016 by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). WP3A continued to work diligently following the Yellow Card and LAREB app releases to complete and launch the HALMED app.
The WEB-RADR General Assembly was hosted on 21 April at the Royal College of Physicians.
The meeting brought together representatives from each partner of the WEB-RADR consortium and, as Dr June Raine explained in her welcome, was organised to provide an opportunity for participants of each Work Package to provide updates on what they had achieved since the launch in September 2014, affirm the excellence in collaboration, and motivate partners to continue their good work to reshape the pharmacovigilance world.
Project Lead Phil Tregunno also highlighted milestones completed over the first 599-days of the project and the communication highlights (publications, presentations, website and Twitter activity).
Dr Robert Ball, representing the FDA, provided a view from the projects external General Advisory Board, and spoke of FDA initiatives related to WEB-RADR, and the need for collaboration and harmonisation.
The processes and results of social media data collection, classification and analytics (ADR detection and signal detection) were demonstrated by Work Packages 2A (Dr Nabarun Dasgupta, Epidemico) and 2B (Dr Johan Ellenius, UMC and Dr John van Stekelenborg, JNJ). Underpinning these results was Ms Victoria Newbould’s (EMA) explanation of WP1’s assessment of relevant EU data protection legislation, stakeholder needs, ethical aspects and plans to elaborate a policy framework.
Representatives of Work Packages 3A (Ms Carrie Pierce, Epidemico) and 3B (Dr Peter Mol, University of Groningen) displayed the three mobile apps (Yellow Card, LAREB and HALMED) that had been developed as part of the project and explained the key barriers and facilitators identified for two way risk communication.
University of Liverpool (Professor Simon Maskell) presented WP4’s assessment of the utility of the app, social media, and the integration of ADR data from multiple sources, alongside LAREB’s quality assessment tool.
After presentations and discussions about each Work Package, the meeting concluded with a lively discussion, with the key themes emerging from the day being; maximising the move to mobile technology and building on current learnings, the areas where social media is useful and how can this be captured and how this technology can be shared globally.
The meeting was a huge success with fantastic contribution from all participants throughout the day, and served to focus the consortium on the months ahead, whilst recognising the significant achievements in the project so far.
Every member of the WEB-RADR consortium should be immensely proud of the work achieved to create lasting technical innovations in drug safety monitoring based on sound science which will potentially improve the public health of millions.
To follow the days progress, please see WEB-RADR’s Twitter posts: @WEBRADR
The Innovative Medicines Initiative WEB-RADR General Assembly meeting will take place on Thursday 21 April 2016 in London.
The meeting will provide an opportunity for representatives of each partner in the consortium to meet and receive updates on the project.
Since the WEB-RADR launch in September 2014, WEB-RADR Work Packages have worked hard, with great commitment and energy. Each Work Package will present achievements and findings to date at the General Assembly meeting.
Novartis WEB-RADR participants, Rajesh Ghosh and David Lewis, have published ‘Aims and approaches of Web-RADR: a consortium ensuring reliable ADR reporting via mobile devices and new insights from social media’ in the Expert Opinion on Drug Safety (14:12, 11845-1853, DOI: 10.1517/14740338.2015.1096342).
This paper provides a detailed look at Web-RADR; the project’s objectives, governance structure and new approaches to modernise pharmacovigilance practises.
The WEB-RADR Yellow Card app has now been released worldwide and will be available for download in non-UK app stores. This update has been made in response to requests from app users who have purchased their mobile devices overseas.
WEBRADR’s WP3B presented their poster ‘Barriers and facilitators for a mobile app to report Adverse Drug Reactions & receive information about drugs’ at the FIGON Dutch Medicines Days 5 – 7 October 2015.
The poster displays preliminary results from the qualitative and multinational study carried out to explore barriers and facilitators of healthcare professionals and patients to using a mobile app for two-way risk communication and their perspectives on a mobile app prototype.
Many congratulations to Work Package 4 teams from University of Liverpool and Novartis for their publication ‘Social Media and Pharmacovigilance: A Review of the Opportunities and Challenges’ in the British Journal of Clinical Pharmacology (BJCP).
This workshop was the first of two workshops organised in the context of the Innovative Medicines Initiative (IMI) WEB-RADR project, which focuses on the evaluation of the use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR). The use of new technology is a great opportunity to empower patients to report and to provide reporters such as healthcare professionals, patients, consumers and carers with accurate, timely and up-to-date information on how to use medicines safely and effectively.
The project will develop a mobile app prototype in support of adverse drug reaction reporting and the provision of drug safety information to app users from medicines regulatory authorities. The mobile app will be subject to a user-based evaluation by focus groups based on a variety of stakeholders of different ages and medical backgrounds.
A second aspect of the project is to assess the usefulness of social media analytics. This includes gathering and aggregating unstructured information from social media with the aim to analyse and to detect potential safety issues related to medicines, which may not be identified through traditional methods in pharmacovigilance.
Whilst new technologies may provide powerful tools in adverse reaction reporting and the monitoring of the safety of medicines, challenges with regard to ethical principles, data protection safeguards, the accountability for data processing, the monitoring of the use of data and the need for enhancing data security and anonymity are also to be analysed. The aim is to develop a policy framework based on recommendations for potential future implementation and use of the WEB-RADR project deliverables.
The workshop provided a unique opportunity to exchange views and to discuss expectations with members of the European Medicines Agency’s Healthcare Professionals Working Party and the Patients’ and Consumers’ Working Party, the Pharmacovigilance Risk Assessment Committee and pharmacovigilance experts, representatives from Young People (Paediatric Committee) experts in the area of medical ethics and data protection and IMI WEB-RADR Consortium members. The outcome of the workshop will inform the WEB-RADR Consortium and the project deliverables.
The MHRA launched the first version of the WEB-RADR Yellow Card app on 14th July 2015, thanks to hard work from Epidemico and the WP3A team. The release has been covered widely by the press and links to articles can be found on our ‘Press & White Papers’ section.
The IMI WEB-RADR consortium has hosted its first workshop on mobile technologies and social media as new tools in pharmacovigilance at the offices of the European Medicines Agency (EMA) in Canary Wharf.
The workshop was arranged by Work Package 1, which focusses on governance and policy, and took place on 10 December 2014. It set out to prepare the foundation for collaboration with consumers, patients, healthcare professionals and medicines regulators throughout the WEB-RADR project. More specifically, the goal was to provide a detailed understanding of the motivations for the project and the research areas, to stipulate the research aspects with the anticipated outcomes and to understand stakeholders’ needs and concerns thus also addressing key areas of data privacy and ethical considerations.
The workshop was the first of two meetings for direct dialogue with member organisations of EMA’s Patients and Consumer Working Party (PCWP) and Healthcare Professional Working Party (HCPWP), Young People representatives of EMA’s Paediatric Committee (PDCO), the chair and vice chair of the Pharmacovigilance Risk Assessment Committee (PRAC), pharmacovigilance experts from EU medicines regulators and US FDA, and consortium partners, as well as ethical and data privacy experts including a legal officer of the European Data Protection Supervisor (EDPS) office. It included discussions with more than 80 participants on:
The application of mobile technologies to facilitate adverse drug reaction (ADR) reporting and access to information on medicines;
The potential use of public social media as data source together with analytical tools to supplement existing signal detection approaches;
The scientific evaluation of the added value of the project deliverables;
Personal data protection and ethical considerations;
The elaboration of recommendations to aid policy development on the future use of mobile technologies and social media as new tools in pharmacovigilance.
From the FDA Centre of Drug Evaluation and Research (CDER) the workshop heard about the reasons why it is important to look into novel approaches in pharmacovigilance thus utilising emerging technologies and data sources based on FDA’s pilot projects (MedWatcher and MedWatcher Social) as well as FDA’s experience in guidance development in this area.
Members of the PCWP and the HCPWP provided important input on user needs and expectations based on a survey launched in preparation of the workshop as well as during the meeting. EURORDIS shared experience on the use of mobile apps from a patient’s perspective, whilst healthcare professional views were further elaborated on by the European Association for Clinical Pharmacology and Therapeutics (EACPT) and the European Academy of Paediatrics (EAP).
A key topic discussed at the workshop was related to data privacy and ethical considerations supported by experts from the Commission Nationale de l’Informatique et des Libertés (CNIL), the EMA and pharmaceutical industry. The legal officer of the EDPS office emphasised the importance of individuals to be empowered by means of transparency and awareness but also by retaining control over their own personal data at any time. This can be achieved based on data protection tools, which were further outlined by the legal officer at the meeting. In this context, reference was also made to the Commission’s Green Paper on mobile Health, which also addresses these aspects. Ethical considerations to be further expanded on as part of the project were highlighted by a medical ethicist and barrister from the UK.
A report from the workshop, together with the slides from the presentations and a recording of the meeting, are published on this website.
A second meeting, which is planned to be an open workshop, will be organised in the 3rd quarter of 2016 (end of year two of the project) and will see also the involvement of data privacy organisations.
In summary, the objectives of WEB-RADR are to:
Develop a mobile application (app) that healthcare professionals and patients can use to report suspected adverse drug reactions to medicines regulators in the EEA.
Assess the possibility for medicines regulators to provide accurate, timely and up to date information on medicines to patients, consumers, healthcare professionals and caregivers through the mobile app.
Explore the identification of potential safety issues with medicines from user comments in social media taking into account compliance with personal data protection legislation.
Develop recommendations as basis for a policy framework for the use of mobile technologies and social media in the context of pharmacovigilance and the monitoring of the safety of medicines.
The WEB-RADR website went live on 5 December 2014 . The launch of the project website, which offers a tool to disseminate information to stakeholders about the consortium and the project aims and objectives, is part of WP5’s (project management and communication) key deliverables.
The launch comes three months after the kick off meeting. The site will enable the project management team to communicate effectively and efficiently with stakeholders, ranging from members of the public, medical professionals, national regulators and industry.
Overall, the project website will provide a central resource for all information about the project over the course of the next three years.
The WEB-RADR webinar, dedicated to the use of mobile devices and social media in the context of pharmacovigilance, took place on 28 October 2014 at the EMA offices in London. Members of the Healthcare Professional Working Group, Patients and Consumers Working Group, Pharmacovigilance Risk Assessment Committee, and IMI WEB-RADR consortium participated in the session.
Overall, the webinar provided stakeholders with a better understanding of project deliverables, and informed participants about the dedicated stakeholder workshop to be organised by the European Medicines Agency on the 10 December 2014.
On Friday 5 September 2014, 45 delegates from across the world met at the MHRA headquarters in London to participate in the launch workshop for the Innovative Medicines Initiative (IMI) WEB-RADR project.
Organised by the MHRA, who are the coordinators of WEB-RADR, the workshop comprised four sessions:
Session 1 – Effective project management of WEB-RADR
Sessions 2 and 3 – WEB-RADR Work Packages
Session 4 – Informal discussions on Work Packages – break-out session
The meeting provided an excellent opportunity to discuss the plans and collaborate with partners, who will be working together over the three-year project.
The enthusiasm of the consortium was clear through the discussions and debate that took place. WEB-RADR was recognised as a significant opportunity to benefit the world of pharmacovigilance.