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Driving industry consensus on the EU’s Medical Devices regulation

Driving industry consensus on the EU’s Medical Devices regulation

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...

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New BioPhorum library and more…

New BioPhorum library and more…

New BioPhorum Library and more... When we started BioPhorum in 2008, we never thought about document curation. But 12 years on and you, our members, have created over 100 best practice papers, guides and tools, so a decent library system is well overdue. And there is more. With the papers announced today in the May newsletter, there are now 110 document packages available, either as direct downloads from the BioPhorum website or via links to 15...

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Microchip electrophoresis and novel excipients: learnings and opportunities

Microchip electrophoresis and novel excipients: learnings and opportunities

Development Group’s (DG) mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, DG now has more than 700+ subject matter experts collaborating in teleconferences every month across 13 collaboration workstream topics. There are also three face-to-face meetings (currently virtual) throughout the year with subject matter experts and key opinion leaders collaborating on the key hot topics and...

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