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European PFAS restriction could jeopardise pharmaceutical manufacturing

European Pharmaceutical Review

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

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Elevating pharmaceutical manufacturing processes with real-time insights

European Pharmaceutical Review

To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.

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Should we be worried about pharma’s supply chain?

World of DTC Marketing

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs). In other words, money over safety.

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions. Conclusion.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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Touring Chiesi’s vision for the future at the new Biotech Centre of Excellence

pharmaphorum

Having a healthy and sustainable pharmaceutical sector is both a necessary requirement and a good one for society. Talking about the integrated supply chain that is always in play with France and Germany, he warned of continuous competition that could pose a gradual risk to Italy’s research basis in development research.

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What factors are driving life sciences FDI in 2022?

Pharmaceutical Technology

Located in downtown Charleston, the Medical University of South Carolina trains approximately 3,000 students a year, with an emphasis on world-class patient care alongside groundbreaking research and innovation. Many companies have their eyes on Charleston right now, as the location performs highly across all of the trending FDI drivers.