ISPE Regulatory Digest Q4 2023

ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.

ISPE President/CEO Fireside Chat with FDA Commissioner

A fireside chat featuring Robert M. Califf, MD, Commissioner of Food and Drugs, US FDA, and Thomas B. Hartman, President and CEO of ISPE, kicked off the 2023 ISPE Annual Meeting & Expo. Dr. Califf provided his perspectives on topics shaping the pharmaceutical landscape including pharmaceutical and biologic innovation and manufacturing, patient access to drugs for rare diseases, artificial intelligence, drug shortage prevention, and the regulatory workforce. Read More

Health Canada on Advanced Manufacturing and Other Trends

Celia Lourenco, Associate Assistant Deputy Minister, presented a keynote at the 2023 ISPE Annual Meeting & Expo addressing new active substances, innovative cell and gene therapies, adaptive artificial intelligence and machine learning, advanced therapeutic products, regulatory agility, modernizing clinical trial regulations and Health Canada’s international collaboration. Read More

Review and Inspection Practices Spotlighted at Global Regulatory Town Hall

ISPE Global Regulatory Townhall Focused on Review and Inspection Practices

Regulators from ANVISA, EMA, Health Canada, WHO and the US FDA exchanged views on collaboration between inspection and dossier review to bring emerging technologies to market faster; streamlining regulatory submission approval processes; the role multinational companies can play in supporting the adoption of harmonized standards from ICH, PIC/S, etc., and more. Read More

ISPE’s Regulatory and Quality Initiatives Deliver Conference Sessions, Articles, and Training

During the 2023 ISPE Annual Meeting & Expo members of ISPE’s Product Quality Lifecycle Implementation (PQLI)® initiative presented updates on ICH Q12, ICH Q14 and M4Q, while ISPE’s Advancing Pharmaceutical Quality team conducted an interactive workshop on Quality Management Maturity in Action. Both sessions included presentations by the US FDA. Read More

Recent issues of ISPE’s Pharmaceutical Engineering® magazine featured articles by several ISPE working groups and initiatives. ISPE’s Continuous Manufacturing team, a working group within the PQLI initiative, published ICH Q13 and What Is Next for Continuous Manufacturing. Another PQLI working, the Patient Centric Specifications team, published A Patient-Centric Review of ICH Q6A and ICH6B. Members of ISPE’s Drug Shortages initiative published Risk Management for Avoidance of Drug Shortages.

Members of ISPE’s ICH Q12 Implementation Team, also a working group within the PQLI initiative, recently conducted training for a group of approximately 30 MHRA reviewers and inspectors. Several representatives from the US FDA participated in the session, sharing their experiences with MHRA.

ISPE’s Drug Shortages and Advancing Pharmaceutical Quality Members Honored

Drug Shortages Publications & Tools

Diane Hustead, Executive Director, Regulatory Affairs, Merck & Co., and chair of ISPE’s Drug Shortages Initiative Team was named ISPE’s 2023 Member of Year. This award honors the ISPE member who made the most significant contribution to the Society during the past year. Under Diane’s leadership, the Drug Shortages Initiative has helped the industry take a comprehensive approach to this critical issue affecting countless patients around the world.

Advancing Pharmaceutical Quality

ISPE’s Advancing Pharmaceutical Quality team was named ISPE’s 2023 Committee of the Year. From 2017 through 2022 this team developed, piloted and published the Advancing Pharmaceutical Quality (APQ) Program in a series of five ISPE guidance documents. The APQ Program has filled an unmet need for quality professionals, one of the largest ISPE member segments.

ISPE Comments on Draft Guidance and Regulations

ISPE recently submitted comments on:

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