COVID-19

Early in March 2020, many around the world viewed the sight of collapsing intensive care units in Northern Italy, overwhelmed by COVID19, with great anxiety and we wondered how we might address the inevitable arrival of the virus at our doorsteps. This concern led to a home-grown initiative in Ireland that brought together representatives of health, commercial and academic organisations...

The current COVID-19 pandemic has heightened the awareness and attention to virus safety and risk mitigation for manufacturers. Each manufacturer has a strategy in place to mitigate the risk, however by manufacturers working together, this can lead to synergies and best practices in the way that the risk is managed. Also, additional guidance is required by the Industry in a field that is...

At the ISPE Singapore Affiliate’s 20th Anniversary Conference on 9-12 December 2020, four international regulators discussed how regulatory authorities and industry were responding to the COVID-19 pandemic crisis.

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 the pandemic have been combined with FDA knowledge from prior public health crises to...