Technical Anonymisation Group (TAG): First meeting

• Date:
  Mittwoch, 29 November 2017, Ganztägig
• Ort:
  European Medicines Agency, Amsterdam, the Netherlands

During its first meeting the TAG discussed the revision of clinical reports published between October 2016 and October 2017 performed by EMA and by the pharmaceutical industry's users software exchange organisation (PhUSE). The group shared industry's and EMA's experience with the anonymisation and review of clinical reports, respectively, and discussed the following issues:

• the impact of anonymisation on data utility;
• legal issues related to the anonymisation of clinical reports, including the impact of the general data protection regulation;
• quantitative methods to measure the risk of re-identification and adversary knowledge.

Documents

Agenda - Technical Anonymisation Group (TAG): First meeting

Reference Number: EMA/579507/2017

Minutes - Technical Anonymisation Group (TAG): First meeting

Reference Number: EMA/797384/2017

Presentation - TAG mandate (A Spina)

Presentation - EMA guidance on anonymisation (K Quigley)

Presentation - Analysis of clinical reports published (A Adriano)

Presentation - PhUSE's analysis of clinical reports published (L Kniola)

Presentation - Case study: Carfilzomib MAA (C Fletcher)

Presentation - Anonymisation of clinical reports: Zinbryta (L Kniola)

Presentation - How to improve the quality of anonymisation reports (AS Henry-Eude)

Presentation - Quantitative methods to measure the risk of re-identification (B Malin)

Presentation - Data utility in anonymised clinical reports (JM Ferran, S Nevitt)

Presentation - Adversary Knowledge (K El Emam)

Presentation - Legal issues with the anonymisation of clinical reports (N Orlandi, L Parker)

Presentation - Impact of the general data protection regulation on the anonymisation of clinical reports (UW Fiedler)