This presentation given by two MediPhorum subject matter experts at the Pre-filled Syringes east coast conference in April outlines the team’s findings on combination product essential performance requirements (EPR’s) interpretation and control strategy development
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MediPhorum Human Factors group recently presented at the Human Factors and Ergonomics Symposium in Orlando USA on 26th March 2023 the results of a survey seeking global insights towards harmonizing best practices in human factors study design and FDA submissions across industry, predominately related to biomanufacturers combination products.
Dec 2022 | Cell & Gene Therapy, Deliverable, Deliverables Report, Development Group, Drug Substance, Fill Finish, Information Technology, MediPhorum, POI - Sustainability, Publication, Regulatory, Supply Chain to Patient, Supply Partner, Sustainability, Technology Strategy
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.
Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper
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 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...
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.