I have been active in ISPE for many, many years, but when I attended my first ISPE Pharma 4.0™ and Annex 1 Conference in Manchester back in 2019, I was surprised by how few people I knew. I realized that my network within ISPE was very much focussed on Aseptic, Manufacturing, and Quality, and not so much on Digitalization and Pharma 4.0™.
The global pharmaceutical industry has faced unprecedented challenges in recent years, with the COVID-19 pandemic serving as a wake-up call for the vulnerabilities within the pharmaceutical supply chain. As the world strives to emerge from the grip of the pandemic and restore activities reminiscent of pre-pandemic times, uncertainties surrounding supply chain stability persist. The
A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023. Professor Anne Greene of TU Dublin and Marty Lipa, Merck & Co., co-chaired the seminar....
The 2023 Europe Hackathon was the largest and most successful one yet. 36 Emerging Leaders from 12 countries descended on Amsterdam, the Netherlands on the weekend preceding the 2023 ISPE Europe Annual Conference to formulate their creative solutions to a real-world pharmaceutical manufacturing challenge.
The Smart Industry Readiness Index (SIRI) is a valuable framework that serves as a solid foundation for the Life Sciences 4.0 journey in Pharma, Biopharma, and Medical Devices manufacturing plants. However, it does have its own shortcomings. This blog presents our point of view, covering the strengths and weaknesses of the SIRI framework, and suggests a potential way forward to complement its...
