The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of anonymisation in each package and the rationale for these methods. As of December 31, 2017, 64 ARs have been published on the clinical data website of the European Medicines Agency. A preliminary high-level analysis of these reports was performed, with the aim of gaining infor - mation on the current industry practices in anonymisation and AR preparation. After excluding 12 ARs from packages that did not contain protected personal data, 52 ARs were analysed. Information on anonymisation methodology, re-identification risk assess - ment, data utility assessment, and use of software is presented.
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Associate Editors
Section Editors
Digital Communication
EMWA News
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Manuscript Writing
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Out on Our Own
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Lay out Designer
Chris Monk