Karl-Heiz is an experienced proffessional within regulatory operations with particular focus on e-documentation, particularly IDMP and the associated systems that support the ability to manage and be compliant with the connected regulations. Highlights include his involvement in a global capacity providing counselling and support on optimisation of eCTD compilation and his current position which has seen him involved in working groups on current ISO issues faced by Eudravigilance and Regulatory professionals.