Speakers Introduction

Is a Medicines Inspector, GxP IT, with the Danish Medicines Agency since 2017.

Leads the agency’s inspection of pharmaceutical industry’s use of IT systems across all GxP areas, and is a frequent speaker at conferences.

Works across all GxP areas, focusing on the integrity of systems and data including the validation and safe operation of systems; and lately, the use of AI/ML in critical applications, for which he has proposed a set of questions in 2021.

Has been a member of and contributor to a number of drafting groups writing guidelines for industry, including but not limited to the PIC/S Data Integrity Guideline, the OECD GLP guidelines on Data Integrity, Cloud Computing, and Security, the EMA Guideline on Computerised Systems in GCP, and currently, the EU and PIC/S GMP Chapter 4.

Since 2019, he 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.

Is an electronic engineer (software) with over 30 years of experience in software design, test, quality assurance, auditing and inspection from within and outside the pharmaceutical industry.