ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
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...
Each year, FOYA showcases innovation, excellence, and progress in the pharmaceutical industry. The winners exemplify state-of-the-art design, cutting-edge technology, and industry best practices, continually setting new standards for what constitutes a winning project. This constant evolution keeps FOYA fresh and original, making it all the more remarkable that FOYA is celebrating its 20th...
The pharmaceutical industry is experiencing a pivotal transformation. As professionals strive to develop therapies faster, more cost-effectively, and with greater precision, Pharma 4.0™ emerges as a powerful framework for change. This evolution is not only technological—it is cultural. It challenges organizations to become more agile, data-driven, and patient-focused.
