Data Governance, a Key Prerequisite for Realizing the Value of Next-Generation Regulatory Information Management (RIM) Systems

18 October 2018

Regulatory is becoming less document- and more data-driven due to the upcoming implementation of new data standards, such as IDMP, FMD, FDA's PQ/CMC and Health Canada's implementation of the Structured Product Monograph as well as operational changes on the regulator side, such as EMA's implementation of SPOR. This is driving a new generation of Regulatory Information Management (RIM) systems and platforms supporting a broader, cross-functional data scope impacting a broader set of stakeholders across the organization. Stakeholders who use and understand the data differently in different contexts. 

Consequently, the key to realizing the promised business benefits in terms of increased efficiency and better integrated business processes and IT systems becomes the establishment of a robust cross-functional data governance to ensure a) a common understanding of the data  b) high quality regulatory data and c) avoid the garbage in, garbage out pitfall. 

In this webinar, guest presenter Jens-Olaf Vanggaard of Highpoint Solutions will:

  • Provide a perspective on best practices for data governance
  • Explain why it is essential to the new generation of RIM systems
  • Share industry experiences with regard to data governance
  • Provide a practical approach to get started with data governance


Jens-Olaf Vanggaard
is Head of HighPoint’s Global R&D Practice based out of Zürich, Switzerland, and has more than ten years of experience providing advisory and implementation services regarding clinical development and regulatory affairs of the Life Sciences industry. Jens-Olaf has strong domain expertise within IDMP, regulatory information management (RIM), master data management (MDM), and data governance. These skills have been honed through extensive project work, participation in industry initiatives such as EMA; SPOR; and CDISC CTR2, and the development of IDMP tools and accelerators. Jens-Olaf has an MSc. in Computer Science and Business Administration from Copenhagen Business School.