Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

Bala heads VB Insights, an advisory firm for the Healthcare and Life Sciences sector. Bala brings over 35 years of experience. During his long tenure, he has been responsible for the introduction of Web, document management, global team collaboration, and regulatory information management applications to large pharma. Until recently, Bala was Head of the Healthcare and Life Sciences Industry Solutions Group at Orion Innovation. As an entrepreneur and a thought leader, he has been involved in initiatives to transform regulatory affairs from a document-centric function to a data-driven function. Bala has been associated with DIA for more than 14 years, most recently as the DIA RIM Working Group subteam lead for the RIM Reference Model.

Kirsten’s current role sees her working closely with professionals in the pharmaceutical industry to implement effective big data and analytical solutions; with particular focus on her technical skills connected to IDMP. Career highlights during 20 years of collaboration with a leading healthcare organisation, which focused on data analysis and business processes, include involvement in CDISC implementation and Clinical Data warehouse solutions.

Karl’s experience in positions of responsibility within regulatory operations spans a period of 6 years with particular focus on e-documentation 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.