Work Packages

The WEB-RADR 2 project consists of five Work Packages. Further information on the aims and partners of each Work Package are outlined below.

Work Package 1: Governance, Sustainability And Project Management

Led by the Medicines and Healthcare products Regulatory Agency (MHRA) and Novartis, WP1 will have overall responsibility for establishing and running appropriate administrative, financial and project processes, as well as reporting on progress of the project to the IMI to ensure quality assurance of the project.

This work stream will be also responsible for internal and external communications strategy, to support interaction between WPs, and to publicise the outcomes and findings of the project ensuring maximum impact.

An essential function of WP1 will be to adapt and implement the sustainability strategy developed by the original WEB-RADR project.

Partners involved:

  • MHRA
  • Novartis

Work Package 2: User Needs And Requirements

This Work Package, led by Lareb and co-lead by MHRA, is responsible for requirement gathering and documentation. The requirements for the WEB-RADR app were documented in the original WEB-RADR project. Work Package 2 will use these, along with gathering information about the needs of National Competent Authorities (NCAs) from the Application Programming Interface (API) reporting component to complete WEB-RADR 2’s technical deliverables. Use cases and requirements of EFPIA partners (European Federation of Pharmaceutical Industries and Associations) will be documented and implemented. The core deliverables from this Work Package will be passed to Work Package 3 for delivery.

Work Package 2 and 3 will work closely. User feedback from each app release will feed into subsequent app enhancements in a circular improvement process. There will be flexibility in the content developed by Work Package 3 to maximise the impact of each new service or enhancement.

Partners involved:

  • Lareb
  • Novartis
  • Lareb
  • UMC
  • Pfizer
  • DKMA
  • HALMED

Work Package 3: Technology Development

Led by the Medicines and Healthcare products Regulatory Agency (MHRA), Work Package 3 will develop user stories for each of the requirements to be tested with the users. It will describe the framework for enhancement release to the platform and deliver those through an agile methodology with iterative, incremental design and build activities with the aim of providing new functionality in a highly flexible and interactive manner in two-weekly cycles to rapidly evolve the platform. These enhancements will be tested by the relevant teams adopting the technology and delivered to the production environment.

Work Package 2 and 3 will work closely. User feedback from each app release will feed into subsequent app enhancements in a circular improvement process. There will be flexibility in the content developed by Work Package 3 to maximise the impact of each new service or enhancement.

Partners involved:

  • MHRA

Work Package 4: Terminology Mapping And Maintenance

Work Package 4 is co-led by ICH and SNOMED International who have responsibility for the MedDRA and SNOMED CT terminologies respectively.

The goals of Work Package 4 are to produce initial bi-directional mappings between SNOMED CT and MedDRA and put in place processes to maintain these two maps. The maintenance process is key to sustaining the maps after the WEB-RADR 2 project ends. The Work Package will also draft the necessary agreements between ICH and SNOMED International to describe the roles and responsibilities of the two organisations to maintain, distribute, and support these maps and to manage any changes in SNOMED CT and MedDRA that impact on either map.

The project has developed a methodology, including coding conventions and quality assurance processes, which have been tested on a subset of terms agreed to be in scope of the work. Work is now progressing to complete the mapping work to an agreed schedule in line with WEB RADR 2 project timelines. In addition, Work Package 4 will produce documentation for users, including use cases, the mapping conventions applied, maintenance/release notes, and relevant history information.

It should be noted that the WEB-RADR 2 project work does not cover a complete map between the  two terminology (SNOMED CT and MedDRA), but an agreed set of frequently used pharmacovigilance terms. SNOMED International and ICH have committed to the maintenance of the two maps after the WEB-RADR 2 project ends.

Partners involved:

  • MHRA
  • Novartis
  • AEMPS
  • AbbVie
  • SNOMED International
  • CSL Behring
  • ICH
  • Pfizer

Work Package 5: Connectivity To EHR Databases

The aim of this Work Package, led by DKMA, is to deliver a framework for two-way information exchange between electronic healthcare record (EHR) systems and the regulatory network. The Team will work with two National Competent Authorities (NCAs) to navigate their own national governance processes to enable adoption of the technology when relevant requirements have been met.

Partners involved:

  • DKMA
  • MHRA
  • Lareb
  • HALMED
  • UMC
  • SNOMED International