Remove Leads Remove Manufacturing Remove Safety
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Hospitals and Medical Device Manufacturers Must Work Together on Cybersecurity

MedCity News

Greater collaboration among healthcare providers, medical device manufacturers, and lawmakers and regulators will lead to predictability and consistency in cybersecurity management. Together, we can make even greater strides toward patient safety and a more secure and sustainable healthcare system.

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Modifier gene therapy – clinical development and manufacturing considerations

European Pharmaceutical Review

Tell us about Ocugen’s lead programme, OCU400. Unlike conventional methods…modifier gene therapy…emphasises the importance of the broader biological system, potentially leading to more effective treatments.” What are the top three challenges associated with gene therapy manufacturing?

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European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Why is microbiological testing in medical device manufacturing important?

European Pharmaceutical Review

This approach can also help determine the appropriate manufacturing processes, sterilisation methods, and maintenance procedures. However, the safety and efficacy of these devices can be compromised if they are not appropriately designed, manufactured, and maintained, the authors wrote. Sharma et al. Sharma et al.

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World-first medicine manufacturing regulatory framework to be implemented

European Pharmaceutical Review

The UK is set to be the first country to introduce a new regulatory framework for innovative products manufactured at or close to the point of patient care, says the Medicines and Healthcare products Regulatory Agency (MHRA). Products manufactured at the point of care are eligible for the MHRA ILAP pathway.

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New UK point of care manufacturing regulatory framework

European Pharmaceutical Review

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced. Clear regulatory expectations and allowing easier product development.