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ISPE members represent a rich and diverse source of expertise for improving regulation and guidance documents. Through its commenting activity, ISPE leverages this expertise for maximum benefit to industry, regulators and patients.
At the 2025 ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products Supervisor at the US Food and Drug Administration’s (US FDA) China Office, delivered a comprehensive update on the agency’s regulatory and inspectional activities. His presentation, titled “FDA Regulatory and Inspection Updates,” offered a detailed look at the FDA’s evolving global strategy, with a...
Regulators from the European Medicines Agency (EMA), the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA), and the Austrian Agency for Health and Food Safety (AGES) addressed the rapidly evolving landscape of pharmaceutical regulation in the digital age on 14 May at the 2025 ISPE Europe Annual Conference in London, UK. The panel discussed key areas shaping the...
It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may be surprising that there are some differences in the approach and content of these regulations and guidelines with the ATMP sector not always clear on the regulatory expectations. A session at the 2025 ISPE Europe Annual Meeting in May 2025, presented by Jon Halling, Managing Director for...
Quality control (QC) manufacturing labs are ripe for transformation. Historically relying on legacy systems and processes that require significant investment and customization to deliver value, it is time to think differently and explore alternative approaches. QC labs have an opportunity to adopt new strategies and tools to design a digital, more connected lab of the future.
The validation industry is entering a transformative era. Amid rising regulatory scrutiny, evolving team structures, and a strong push toward digitalization, professionals across the life sciences are being called to do more, with leaner teams and tighter timelines.
Explore June’s top reads in Pharmaceutical Engineering®—from cleanroom pressure design and AI validation to modular cell therapy manufacturing and ATMP access. Discover strategies for resilience, sustainability, and speed in pharma facility innovation.
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled computerized systems in regulated life science areas. It bridges established GAMP concepts with...
