Shaping the Future of Regulatory Affairs: Insights from the 5th Annual Pharmaceutical Regulatory Affairs Summit

Our VP of Sales and Marketing, Manfred Voglmaier, recently attended the 5th Annual Pharmaceutical Regulatory Affairs Summit in Berlin — a two-day event gathering industry leaders to explore the future of regulatory data and its impact on global health innovation.

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The discussions, case studies, and roundtables all pointed in one direction: structured, standards-based, and interoperable regulatory data is rapidly becoming the backbone of the pharmaceutical industry’s digital transformation.

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Five key insights emerged from the summit:

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1. Data is the new driver — Structured, machine-readable regulatory data (IDMP, EMA-PMS, eCTD 4.0, PLM Portal) is now essential for future-proof submissions.
2. AI is entering the regulatory domain — Artificial intelligence is beginning to enhance content authoring, data management, and submission planning, moving from theory to real-world application.
3. Regulatory Affairs is evolving — The function is increasingly recognized as a strategic business partner, driving digital change and cross-functional collaboration.
4. Global harmonization remains a challenge — Despite slow progress, aligning regulatory frameworks is key to improving access, reducing duplication, and accelerating time to market.

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Ontologies and semantics are gaining ground — Managing structured product data through ontologies is emerging as a critical enabler of speed, consistency, and data quality.

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As Manfred summarized, the winners will be those who can structure, link, and govern data — not just documents. The message from Berlin was clear: the future of Regulatory Affairs lies in data-driven intelligence, collaboration, and standardization.