In Regulatory Insights for Life Science , our experts compile and analyze developments in areas such as EU GMP, AI regulation, MDR/IVDR, NIS2, quality management, and sustainability.
In over 80 pages, you’ll not only learn what’s changing, but also how these developments are interconnected, what they might mean for your business, and which issues need to be put on the agenda right now.
What regulatory changes will affect the life sciences sector going forward?
Regulatory Insights for Life Science provides you with a comprehensive overview of the regulatory changes shaping the next phase of the life sciences industry—and a better foundation for determining what your organization needs to monitor, prioritize, and begin preparing for.
The report analyzes seven areas where progress is particularly rapid:
1. EU GMP – New Requirements in a Digital and Data-Driven Environment
Get an overview of the developments in EudraLex Volume 4, including Chapter 1, Chapter 4, and the revisions to Annex 11 and Annex 19.
2. EU Biotech Act
The report also highlights developments surrounding the EU Biotech Act and the goal of strengthening Europe’s competitiveness, innovation capacity, and resilience in the fields of biotechnology and life sciences.
3. AI Regulation—From Experimentation to Governance
What do the EU AI Act, FDA guidance, the upcoming EU GMP Annex 22, and ISO/IEC 42001 mean for the use of AI in the life sciences? The report highlights the trend toward clearer requirements for governance, intended use, and lifecycle management of AI systems.
4. MDR and IVDR – Ongoing Changes in MedTech and IVD
Get a comprehensive overview of developments under the MDR and IVDR and the ongoing shift toward a more risk- and lifecycle-based regulatory approach.
5. NIS2 and Information Security
NIS2 and ISO/IEC 27001 raise the bar for cybersecurity, risk management, business continuity, and organizational accountability—issues that are becoming increasingly important in digitized life sciences operations.
6. Quality Management Systems
Developments in quality management point toward a broader focus on risk, leadership, resilience, and an organization’s ability to manage change.
7. Sustainability Becomes a Regulatory Issue
CSRD, PPWR, REACH, RoHS, and ISO 14001 entail new or changed expectations regarding, among other things, sustainability data, materials, packaging, reporting, and environmental management.
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