Data Integrity & IT Compliance Group Developments September through December 2025
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Regulatory Comments
- Commenting on the drafts of the EU GMP Guideline Chapter 4 'Documentation' and Annex 11 'Computerised Systems' published on 7 July 2025, together with the APV's expert group 'Informationstechnolgieformation'.
- Commenting on the draft of the EU GMP Guideline Annex 22 'Artificial Intelligence'
Micellaneous
- Organisation of an online seminar in regard to the drafts of EU GMP Guideline Chapter 4 'Documentation' and Annex 11 'Computerised Systems' on 4-5 September 2025
- Organisation of an ECA AI Conference focusing on Annex 22 “Artificial Intelligence” on 5-6 November 2025 in Copenhagen, with Ib Alstrup, among others.Ib Alstrup has chaired the drafting group and been the EMA rapporteur for the revision of the EU and PIC/S GMP Annex 11 on Computerised Systems and the new GMP Annex 22 on Artificial Intelligence.
- The 2nd conference on Annex 22 / AI is planned for 7-8 October 2026 in Copenhagen.