ISPE is committed to fostering communications and interactions to advance common interests among the pharmaceutical industry and regulatory agencies.
Reimagining Global Drug Approvals
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For many years, global implementation of post approval changes often required seven or more years, delaying access to improved manufacturing methods. Through various reliance initiatives and collaborative efforts, the timeline has already been reduced to three to five years. Genentech now aims to further accelerate global approval timelines to approximately 18 months. READ MORE
Pharma 4.0 and AI: Unlocking Innovation and Driving Transformation
Digital transformation and emerging technologies such as AI/ML are driving a technological revolution across the entire product lifecycle. A critical area of focus is the GMP-regulated segment of the supply chain. An industry-regulator panel at the 2025 ISPE Pharma 4.0™ Conference exchanged views on how to foster AI/ML innovation without compromising safety and efficacy. READ MORE
Critical Deficiencies Undermine QRM Effectiveness
Despite years of comprehensive training in pharmaceutical quality systems, ICH Q10 implementation, and other industry initiatives, serious quality defects persist. This is a persistent challenge that the ICH Q9(R1) revision specifically aims to address through enhanced quality risk management (QRM) practices. Discover the insights, challenges, and real‑world solutions reshaping the future of PQS effectiveness. READ MORE
Decentralised Manufacturing: A New Era for Medicines and Healthcare
The MHRA’s Decentralised Manufacturing framework marks a significant shift in pharmaceutical production, supporting flexible, personalized, and resilient models. By enabling approaches such as Point‑of‑Care and Modular Manufacture, the framework responds to advances in science and technology to create a more agile, patient‑focused system that accelerates access to needed therapies. READ MORE
Crisis Management and Partnership with FDA: North Cove’s Recovery After Hurricane Helene
In September 2024, a category 4 hurricane hit the Baxter North Cove facility in North Carolina, the largest manufacturer of intravenous and peritoneal dialysis products in the US. A close partnership between Baxter and the FDA brought the facility back to nearly 85% of normal capacity in just 60 days. READ MORE
ISPE Regulatory Volunteer Spotlight: Bob Iser, Genentech
Bob Iser is the Global Head of Quality Policy & Advocacy at Genentech (Roche), where he draws on 30 years of experience to ensure medicines are produced at the highest quality and in compliance with global health authority regulations. He is a senior leader who leverages deep experience as a former regulator (USFDA) and a practical biotech industry professional to address complex quality, CGMP compliance, and regulatory challenges. Passionate about influencing policy, Bob has been a frequent contributor on CMC, CGMP, and USFDA policy topics in a variety of expert groups including ICH, USP, ISPE, PDA, PhRMA, and AAM. In ISPE, Bob chairs the Regulatory Steering Council, the group that guides ISPE’s regulatory endeavors. When asked what he finds rewarding about his work with ISPE, Bob noted that he truly appreciates interacting with such a large community of experts in a number of fields that not only drive for state-of-the-art process and product improvements, but, at the end of the day, are aligned to bring new life-saving medicines to patients. In his free time, Bob enjoys traveling with his family, watching sports, and reading.
For more information, contact Carol Winfield, Sr. Director Regulatory Operations, ISPE.