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.

V. “Bala” Balasubramanian is Senior Vice President and Global Head, Industry Solutions Group for Healthcare and Life Sciences at Orion, a global digital transformation products, solutions and services firm. Bala has over three decades of IT and digital transformation experience. Prior to Orion, Bala was the President and CEO of Cabeus, a niche Life Sciences services firm where he was also responsible for vision and strategy for a cloud platform called ReALM® to transform the regulatory value chain for Life Sciences. Bala developed IT strategies and capabilities for Bristol-Myers Squibb, Roche, Aventis, Merrill Lynch, AT&T, Bell Atlantic and IBM. Bala has his PhD and MBA from Rutgers University and MS in Computer Science from NJIT.

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.