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Regulatory
The right validation model: practical considerations and applications
It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey
Manufacturing
Going beyond the guidance: getting business benefit from change management
Change management offers a broad, system-wide perspective that includes the oversight and management of all changes and the change process. Michelle Anastasi of PharmaLex explores what good change management looks like and who should be involved
Regulatory
European Commission adopts proposal to delay MDR deadlines
With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns about widespread product shortages in the EU market have been growing
Regulatory
Investment, outsourcing and globalisation: key trends for 2023
The start of 2023 has been challenging for the pharmaceutical industry. Economic constraints in Europe and the United States, staffing shortages, an increasingly complex regulatory environment and heightened competition for funding is putting pressure on companies