Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...
At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for cell and gene therapy was held. This session invited experts in their field to review...
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety (AGES) provided a much-anticipated presentation on the requirements for data management in light of the revised Annex 1 at the 2024 ISPE Pharma 4.0™ and Annex 1 Conference in Rome, Italy in December 2024.
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan base, and an energy that electrifies the stadium. Some people are casual viewers—they check the scores, maybe attend a game now and then. Others are fanatics (sometimes even crazed fanatics). They wear the jersey, know the stats, engage in every play, cheer and yell at the team and opponents, and...
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large molecules and cell and gene therapies, has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in...
As we approach International Women’s Day 2025, this year’s theme highlights the importance of accelerating action. ISPE’s Women in Pharma® embodies these principles by creating a platform for connection, growth, and empowerment. Hear what these Women in Pharma® members have to say about the value of Women in Pharma on International Women’s Day.
The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying ahead of the curve is not just beneficial—it's essential. Professionals need reliable, up-to-date resources to navigate the complexities of regulatory requirements, technological advancements, and industry best practices. This is where the International Society for Pharmaceutical Engineering...
