NNIT GPRAS 2021: Utilize IDMP and Data Governance to improve your business process.

Presented at the Global Pharmaceutical Regulatory Affairs Summit (GPRAS), this video directly addresses critical challenges and solutions within the pharmaceutical industry related to regulatory compliance (IDMP), data management, data governance, and business process optimization.

This video explores the critical role of IDMP (Identification of Medicinal Products) and data governance in improving business processes within global pharmaceutical companies. Niels Leander, Global Head of Regulatory Affairs at NNIT, emphasizes that data quality is an organizational discipline requiring cross-functional collaboration and management commitment, not just a technical fix. He highlights that while achieving IDMP compliance is challenging, maintaining it over time presents an even larger undertaking, necessitating robust data governance. The discussion positions data governance as a foundational aspect of digital transformation, essential for treating regulatory data as a strategic asset, addressing new data consumers, and navigating data-centric regulations like IDMP. The speaker outlines common signs indicating a need for data governance (e.g., excessive time spent searching for data, low data confidence) and the benefits of its implementation, including reduced manual work, improved data sharing, enhanced compliance, and increased trust in data.

Key Takeaways:

• Data Governance as a Foundational Pillar: Data governance is presented as an essential, foundational element for digital transformation and achieving/maintaining IDMP compliance in pharmaceutical regulatory affairs, moving beyond mere technical solutions to encompass organizational change and management commitment.
• IDMP Compliance is an Ongoing Endeavor: Becoming IDMP compliant is just the first step; maintaining compliance requires continuous data quality monitoring, robust data management, and a sustained organizational effort, underscoring the long-term value of data governance.
• Strategic Value of Data: The video stresses the shift towards viewing regulatory data as a strategic asset, with data governance enabling better data sharing within and outside regulatory affairs (e.g., with safety and manufacturing), leading to more efficient operations and better insights.
• Addressing Data Pain Points: Effective data governance directly tackles common industry challenges such as specialists spending excessive time searching for data, lack of confidence in data quality, and fragmented data platforms, ultimately reducing manual workload and activating automation.
• Systematic Implementation Approach: Implementing data governance requires a systematic approach, including defining a clear vision, assessing current maturity, developing a roadmap, establishing business cases, and creating distinct strategic, tactical, and operational roles (including data stewards), often best initiated with a minimal viable product (MVP) focused on a critical use case like IDMP.
• Management Buy-in is Crucial: Any data initiative, particularly data governance, will fail without strong management commitment. Data governance provides the necessary structures to engage leadership, demonstrate the strategic importance of data, and secure the required support.