Study identification

PURI

https://redirect.ema.europa.eu/resource/42291

EU PAS number

EUPAS42268

Study ID

42291

Official title and acronym

Report on PRAC Pilot on Rapid Data Analytics

DARWIN EU® study

No

Study countries

France
Germany
United Kingdom

Study description

A pilot on rapid data analytics (referred to in this report as RDA) coordinated by the European Medicines Agency (EMA) was performed with the Pharmacovigilance Risk Assessment Committee (PRAC) from November 2019 to January 2021. Its aim was to test the feasibility and usefulness of a process for rapid identification, analysis and reporting of results of epidemiological questions that may arise in the context of regulatory assessments for which Real World Data (RWD) and Real-World Evidence (RWE) can support regulatory decisions by filling knowledge gaps identified during a procedure. The pilot was part of the 2020/2021 PRAC and Big Data Steering Group workplan and it should be seen as a first step towards the promotion of a wider use of RWD/RWE in the development, authorisation and post marketing surveillance of medicines.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Kelly Plueschke

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable