FDA Commissioner Stephen M. Hahn, MD, spoke about the lessons learned from COVID-19 in a presentation during the ISPE Annual Member Meeting on 5 November at the 2020 ISPE Annual Meeting & Expo. He discussed how the FDA has been responding to the pandemic, including how actions taken in response to...
2020 ISPE Europe Annual Conference At the 2020 ISPE Europe Annual Conference on 16–17 September, which was a virtual conference, three regulatory panel discussions included more than 20 regulators from eight countries and the European Medicines Agency (EMA), Medicines and Healthcare Products...
Learning Level: Basic - Drug shortages are not just a supply chain problem. They are a problem for patients. Sometimes these patients are so at risk, resolving the shortage could make the ultimate difference. During this...
Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the...
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “Avian Flu—Is My Company Prepared?” by Wendy Haines and Martin Rock.Haines, W., and M. Rock. “Avian Flu—Is My Company Prepared?” Pharmaceutical Engineering 26, no. 6 (November-December 2006): Online Exclusive....
Learning Level: Basic - In a fireside chat format our speakers will discuss their vision of the Pharmaceutical Supply Chain in the next 3 to 5 years as the Pandemic and other factors accelerate change. Understanding the...
Learning Level: Intermediate - The SARS-CoV-2 worldwide pandemic has presented a significant challenge to business continuity for pharmaceutical manufacturing. It has led to Industry re-assessing the virus control...
As the COVID-19 pandemic continues, pharmaceutical companies are taking steps to address the short-term consequences while also preparing for what may be the long-term effects for the world, individual nations, and the pharmaceutical industry. In late April and early May, Pharmaceutical...
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)...
A panel of industry experts from a variety of disciplines discussed key challenges to the global pharma supply chain due to the current coronavirus pandemic during the “COVID-19: Pharma Supply Chain Security and Robustness During a Global Pandemic ” ISPE...