Marketing authorisation holders are expected to maintain awareness of scientific publications through a systematic review of literature published on widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. Reports of suspected adverse reactions from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, should be reviewed and assessed to identify and record case reports of adverse events originating from spontaneous reports or non-interventional post-authorisation studies.

In addition, if a marketing authorisation holder becomes aware of a report of suspected adverse reactions originating from a non-medical source, for example the lay press or other media, it should be handled as a spontaneous report.

Red Line is equipped to support your company with weekly literature searches which forms part of the pharmacovigilance surveillance process. Retrospective searches are managed as an added service to any of the above activities or to provide support to a new project under development by the company.

On-going product surveillance is carried out using our weekly Alert Manager to manage high hit rates efficiently and effectively. Search results are uploaded to our bespoke built, Literature Monitoring System (LMS) and screened by qualified staff members. Individual cases and published studies can be tracked through a controlled work-flow process that facilitates prompt expedited reporting to regulatory authorities including, PV partners, and documents a full audit trail for each search.