Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health. The healthcare sector is responsible for 4–5% of global emissions, more than 70% of which are driven by supply chains. There is therefore an increasing need to focus on reducing emissions across our sector. Many organizations have set or aligned with science-based targets, requiring them to work with their...
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Quality and regulatory alignment of the BioPhorum technical workstreams
Jul 2022 | Long Read, Supply Chain to Patient, Uncategorised
BioPhorum has made significant progress over the last year and it continues to deliver benefits to its members. For example, there is a new Sustainability Phorum, an increasingly diverse webinar program, and the workstreams have delivered more than 100+ technical publications. Yet, there is always more to do.
Driving industry consensus on the EU’s Medical Devices regulation
Feb 2022 | MediPhorum, News, Uncategorised
The EU Medical Device Regulation (MDR) Article 117 became legally binding and mandatory in May 2021, but there is no clear industry consensus regarding its application to integral drug delivery devices. The regulation is particularly unclear in the case of a device constituent part being classified as an invasive device, and whether all drug product contacting components must conform to the requirements for invasive components. There are also...