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.
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Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper
Jan 2022 | Deliverable, Deliverables Report, EU MDR, MediPhorum, Publication
The EU 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 ambiguities regarding requirements such as notified body opinion and human factor study requirements. This paper presents an industry position statement and illustrates the concerns.
BioPhorum deliverables mid-year report 2021
Jul 2021 | BioPhorum, Cell & Gene Therapy, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, Regulatory, Supply Partner, Technology Strategy
BioPhorum is here to help you make better decisions, faster in your operations. Membership puts you and your team at the center of current debates and helps you to stand shoulder to shoulder with those moving the performance dial on challenges that need a collective voice and a global perspective to resolve. The BioPhorum Deliverables Report is a consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry...
Covid-19: How industry is using technology during the covid-19 pandemic
Sep 2020 | Cell & Gene Therapy, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, Regulatory, Supply Partner, Technology Strategy
This article looks at the role of technology in the workplace and specifically how the Senior BioPhorum Connect group is addressing issues such as the use of remote working technologies, cyber security and digitizing the cGMP space.