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Fimea submitted a report on the use of RWD to the Ministry of Social Affairs and Health

Fimea submitted a report on the use of RWD to the Ministry of Social Affairs and Health

27.11.2018

The Finnish Medicines Agency Fimea has prepared a report on the use of RWD. The report was commissioned by the Ministry of Social Affairs and Health. Fimea submitted the report today, on 27 November, to Päivi Sillanaukee, Permanent Secretary of the Ministry of Social Affairs and Health.

Ever-growing knowledge about health and diseases, increased ability to analyse large amounts of data and the development of precision medicine create both needs and possibilities related to the use of real-world data (RWD).

RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, such as patient information systems, registers, databases and biobanks. RWD is used in various applications, including patient care, evidence based practice, and research, development and innovation activities. Views on various operators’ data needs and the applicability of RWD are only just developing.

According to the report, high-quality single entry is a prerequisite for the use of RWD. The report describes concrete national-level and international activities that aim to advance the appropriate use of RWD. The report describes the uses of RWD from the perspectives of regulation of medicines and medical devices, health technology assessment (HTA) and rational use of medicines.

The proposals for measures presented in the report are intended for decision-makers and experts who participate in the regulation of medicines and medical devices, HTA, and national steering in Finland. The proposals are related to the specification of data needs, revision of processes, strengthening of expertise and communicating about data needs and requirements.

Report: Why do we need real-world data? Examined from the perspectives of medication and medical device regulation, health technology assessment and national steering (Julkari, in Finnish)
 

Ask more

  • Piia Rannanheimo, Pharmacoeconomist, +358 29 522 3517
  • Hanna-Mari Jauhonen, Research Physician, +358 29 522 3512
  • Email address format: firstname.lastname@fimea.fi
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