ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
The Future of Pharmaceutical Regulation and AI
ISPE’s 2025 Global Regulatory Town Hall focused on the future of pharmaceutical regulation with a focus on digital transformation and how Pharma 4.0 is revolutionizing drug manufacturing development through the integration of artificial intelligence (AI). The Town Hall, held as part of the 2025 ISPE Annual Meeting & Expo, featured an interactive industry-regulator panel that addressed compliance challenges and evolving regulatory expectations, as well as real-world industry applications and innovations driven by AI. READ MORE
Navigating the Challenges of Transportable/Point of Care Manufacturing
Advancements in technology such as process intensification, continuous manufacturing, and 3D printing are enabling manufacturing models such as distributed, point-of-care, and transportable manufacturing. While these platforms are redefining what’s possible, they also raise critical questions about regulation, quality, and global harmonization. A session at the 2025 ISPE Annual Meeting & Expo explored the technologies, best practices, challenges, and regulatory thinking that impact the realization of these manufacturing platforms. READ MORE
Innovation and Regulatory Harmonization in Latin America: Report on an ISPE Workshop
ISPE’s Enabling Pharmaceutical Innovation team partnered with Brazil’s National Health Surveillance Agency (ANVISA) to host a workshop dedicated to advancing innovation and regulatory harmonization across Latin America. The event provided a platform for dialogue on reducing regulatory barriers and fostering collaboration between industry and health authorities to accelerate adoption of innovative manufacturing practices. READ MORE
ISPE Members Join National Dialogue on Drug Supply Chain Security
Two ISPE members participated in the recent workshop titled Improving Resiliency in the U.S. Pharmaceutical Supply Chain Through Make-Buy-Invest Strategic Actions organized by the National Academies of Sciences, Engineering, and Medicine (NASEM). The workshop convened experts to examine how "make" (domestic production), "buy" (partnerships with international suppliers), and "invest" (source shifting) strategies can strengthen the U.S. pharmaceutical supply chain and safeguard national health and security. READ MORE
ISPE Regulatory Volunteer Spotlight: PQLI Working Groups Named ISPE 2025 Committee of the Year
The ISPE Product Quality Lifecycle Implementation (PQLI)® Committee’s ICH Q2 and Q13 teams were recognized as ISPE’s Committee of the Year for having made exceptional global contributions to advancing ISPE’s mission through regulatory collaboration, technical excellence, and education. Over the past three years, these members have organized and delivered six customized training programs on ICH Q12 and Q13 to Health Authorities across four continents, including ANVISA (Brazil), Health Canada, Jordan FDA, INVIMA (Columbia), MHRA (United Kingdom), and HSA (Singapore), some with participation from the U.S. FDA. These sessions trained more than 500 inspectors and reviewers worldwide, strengthening regulatory understanding and harmonization while reinforcing ISPE’s leadership in delivering manufacturing and supply chain innovation, operational excellence, and regulatory insight. READ MORE ABOUT PQLI
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.