Adverse Event Reporting

In a constantly evolving technical and regulatory environment, Efor teams provide their expertise in pharmacovigilance, materiovigilance, reactovigilance and cosmetovigilance of marketed products.

Our expertises PVMV

Quality System

For medical devices and in vitro diagnostic devices, articles 87 to 89 of Regulation (EU) 2017/745 and articles 82 to 84 of Regulation (EU) 2017/746 require from our clients the ability to evolve their systems. In the pharmaceutical industry, good pharmacovigilance practices and the Public Health Code guide our actions.

Our vigilance experts assist manufacturers in the implementation and upgrade of their quality management system, including:

  • Writing procedures and associated forms
  • Preparation or maintenance of the Pharmacovigilance System Master File (PSMF) and its summary
  • Implementation of bibliographic monitoring
  • Team training through our certified training organization

Data management and trend analysis

Exploitation of vigilance data allows our clients to consolidate their analytical processes, measure risks, and document their decisions. With the possibility to outsource the management of vigilance data, we ensure the collection, processing, analysis, and presentation of data on behalf of our clients. We manage the recording and monitoring of cases and trends through a commercial database and can also provide reporting to Eudravigilance for medicinal products. With our expertise in statistics and data management, our teams conduct trend analyses of incidents related to medical devices and in vitro diagnostic devices. In the case of a significant increase in trends, we draft the associated trend report.

Safety reports drafting

The value proposition revolves around the complete or partial outsourcing of periodic reporting.

In the pharmaceutical industry:

  • Writing of the Risk Management Plan (RMP) and preparation of risk mitigation measures

In the medical device and IVD industry:

  • Writing of MIR, FSN, FSCA, periodic summary reports
  • Writing of post-market surveillance plans and reports (PMS/PSUR)
  • Updating risk analyses and technical documentation accordingly

Backlog management – Task force

With Competent Authorities constantly raising the bar regarding quality, the management of complaint backlog is an important issue for Life Sciences industries.

In this regard, we work on limiting the impact in terms of workload for internal teams, to allow our clients to fully optimize their resources. Efor offers the creation of a task force dedicated to reducing backlog complaints and regularly monitoring the progress through dashboards and KPIs.

Our interventions

  • Structuring

    Structuring post-market surveillance activities for medical devices is an important challenge. Our collaborators provide their expertise for the management of vigilance cases, from reception to closure, including the necessary investigation for the processing of these incidents.
  • Trends

    The requirements for post-market follow-up of medical devices also involve other activities besides vigilance, such as drafting PMS/PMCF plans and PMS/PSUR/PMCF reports. Today, thanks to the work of our Technical Department, Efor has been able to offer clear and adapted tools to ensure the collection and analysis of trends in all PMS data.
  • Trainings

    The requirements related to post-market surveillance of healthcare products are numerous and constantly evolving. Thanks to our training platform, Tree, we have provided our clients with tailored training programs to enhance their understanding of these requirements, and consequently implementing pertinent and pragmatic PMS/CPMS measures.
  • Backlog

    By assembling a team of ten experts in less than two weeks, we successfully created an offer for a project to reduce the complaint backlog of a client within a three-month deadline.
  • Optimization

    Our teams of consultants strengthen our clients’ teams to ensure optimized management of vigilance cases, from their reception to closure.

« With our position as a leader in the field of health product safety, it is natural that we address our clients’ vigilance needs. »

– Florence TREPANT – Technical Manager Regulatory Affairs

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