ISPE is dedicated to keeping our members up to date on the latest news and resources about COVID-19 and the ways the pharmaceutical industry is adapting to ongoing developments. One valuable resource is the Food and Drug Administration’s (FDA) question-and-answer-post, Manufacturing, Supply Chain, and Drug Inspections (COVID-19), which provides guidance on how to implement manufacturing and site changes as well as reporting to an application. The Center for Drug Evaluation and Research (CDER) is continuing drug reviews while responding to public health needs associated with the COVID-19 outbreak while the FDA continues to be adaptable and transparent.
This valuable resource covers how inspections are going to be affected due to COVID-19 and includes information on:
During this time of uncertainty, it is more important than ever that the pharmaceutical industry be able to continue research as well as manufacturing and distribution. ISPE is here to support our members, help them continue their quest for knowledge, and provide them with ways to stay connected. Our COVID-19 (Coronavirus) Pharma Industry Resources Page has a complete list of global and local resources available to you including articles, webinars and links to industry information.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...