NNIT is part of this year's GPRAS, which will be held virtually from 20-22 April, 12.20-12:45 PM (CEST).
At the virtual conference, Niels Buch Leander
, will be speaking about "Utilizing IDMP and Data Governance to Improve your Business Proocess".
IDMP is now moving from more conceptual discussions to actual implementation. In order to prepare for the implementation, a view to submission processes impacted by IDMP will be needed. Existing processes will require adjustments and new processes will need to be defined and implemented. Importantly, data quality needs to be lifted and monitored on a continuous level, and this requires both tools and processes regarding data governance to be successful. This session will talk about the importance of data governance for IDMP compliance and for improving the Regulatory Affairs processes going forward.
- Evaluating processes in scope for IDMP
- Showing importance of data governance for a successful IDMP program
- Discussing best practices for data governance in relation to IDMP
Dr. Niels Buch Leander is Advisory Director and Global Head of Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 12 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and IDMP and hence extensive experience with regulatory data standards and their implementation. He advises global pharmaceutical companies on their business architecture and information architecture.