Real-world data: general regulatory approaches in the EU and Japan-Reference-Cited by-同舟云学术

Real-world data: general regulatory approaches in the EU and Japan

Published:2022-02-25 Issue:1 Volume:2 Page:11-16
ISSN:2782-3784
Container-title:Real-World Data & Evidence
language:
Short-container-title:MyRWD

Author:

Borzova M. A.¹^ORCID

Affiliation:

1. "Trubor" Law Firm

Abstract

The article describes the regulatory approaches to the collection, analysis and usage of real-world data applied in the European Union and Japan.

Publisher

Publishing House OKI

Reference18 articles.

1. Guidance for companies considering the adaptive pathways approach. Available from: https://www.ema.europa.eu/en/documents/regulatory-proceduralguideline/guidance-companies-considering-adaptivepathways-approach_en.pdf.

2. EMA Regulatory Science Strategy to 2025. Available from: https://www.ema.europa.eu/en/about-us/howwe-work/regulatory-science-strategy#regulatoryscience-strategy-to-2025-section.

3. HMA-EMA Joint Big Data Taskforce. Available from: https://www.ema.europa.eu/en/documents/minutes/hma/ema-joint-task-force-big-datasummary-report_en.pdf.

4. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology (Revision 9). Available from: https://www.encepp.eu/standards_and_guidances/documents/1.ENCePPMethodsGuideRev.9.pdf.

5. EFPIA’s Position on the Use & Acceptance of RealWorld Evidence by International Markets. Available from: https://www.efpia.eu/media/602956/efpia-rweposition-paper_aug2021.pdf.

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