ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
FDA on Artificial Intelligence, Critical Thinking
As AI reshapes life sciences, FDA National Expert Drugs, Lt. Seneca Toms, reminds industry leaders that responsibility remains unchanged. Speaking at the 2026 ISPE AI in Life Sciences Summit, Toms emphasized that while AI can enhance decision-making, quality, and efficiency, organizations must continue to apply critical thinking, risk management, scientific judgment, and oversight to ensure safe, effective, and high-quality products. READ MORE
An Overview of Recent Digital/Artificial Intelligence (AI) Guidelines in the Asia-Pacific Region
As artificial intelligence gains momentum across the life sciences industry, regulators throughout Asia Pacific are rapidly shaping expectations for its responsible use. ISPE’s Regulatory Quality Harmonization Committee’s Asia-Pacific regional group reviews emerging AI policies and guidance from Australia, ASEAN, Singapore, South Korea, and China, highlighting key trends that pharmaceutical professionals should understand as regulatory frameworks continue to evolve. READ MORE
Fast-Tracking Drug Development: How Science, Strategy, and Structure Enabled Rapid CMC Success
Members of ISPE’s Product Quality Lifecycle Implementation (PQLI)® initiative recently published experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation. READ MORE
Related: ISPE’s Product Quality Lifecycle Implementation (PQLI)® initiative advances solutions in emerging regulatory and scientific topics related to chemistry, manufacturing, and controls (CMC) and good manufacturing practice (GMP) approaches to ensure product quality. LEARN MORE
ISPE Launches Regulatory Insights Webinar Series
These live, interactive conversations bring regulators and industry leaders together for candid, one-on-one conversations on emerging expectations, guidance, and real-world operational implications across the product lifecycle. The first episode featured Adam Fisher, Director, Enterprise Project Staff, US FDA, and Bob Iser, Global Head, Quality Policy & Advocacy, Genentech/Roche Inc, discussing how industry can effectively engage with the US FDA on advanced manufacturing technologies.
Regulatory Insights: Navigating FDA's Advanced Manufacturing Engagement Landscape: Programs and Practical Insights
Must be an ISPE member to view
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.