In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of the global audience.
ISPE is pleased to announce that its Drug Shortages Initiative Task Team is launching a new phase of work to focus on business continuity planning for the prevention of drug shortages. We invite your company to participate. The first activity is a benchmarking study that will launch in May 2021 and be used to assess best practices and industry accomplishments in the area of business continuity...
During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical supply chain practices. Patients and regulators were increasingly asking: what are best practices...
As noted in the ISPE Drug Shortages Prevention Plan,1 business continuity planning is a powerful, methodology, essential...
As noted in the ISPE Drug Shortages Prevention Plan,1
The individual stories of patients—and their families—are welcome reminders to the pharmaceutical industry about just how meaningful pharmaceutical development, manufacturing, and delivery are every day to those patients and their families.
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent engagement with health authorities is a powerful opportunity for drug manufacturers to...
