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Staying abreast of regulations with NGS?based viral safety for faster, safer and more ethical lot release of our vaccines

European Pharmaceutical Review

As the healthcare sector grows, there is a clear trend towards the expansion of biologic therapeutic drugs and vaccines like the one developed by Novavax. How does that impact the safety of the biologics? First, we see a global trend of developing more ethical solutions for the safety testing of biologics. PathoQuest.

Ethics 81
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Improving Access to Medicine: The Role of Pharma Companies in Emerging Markets

PM360

Access to medicines have persisting and systemic differences across the globe and within countries. It is estimated that nearly two billion people globally do not have access to essential medicines. Traditionally, pharmaceutical companies have not prioritized emerging markets as part of their access strategy.

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MHRA regulation overhaul: new scheme for lowest-risk UK clinical trials

European Pharmaceutical Review

A new scheme from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to cut the approval time for the lowest-risk clinical trials in the UK by over half. This will be the case if the trial sponsor can demonstrate the trial meets the MHRA’s criteria, such as safety issues of the investigational medicine.

Ethics 90
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How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer

MedCity News

Artificial intelligence (AI) is rapidly transforming the healthcare industry, with its ability to process and analyze vast amounts of data. One example of how AI is already being used to personalize cancer treatment is in the field of precision medicine. Even just a year ago, we couldn’t fathom a cure for cancer. Now, we can.

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New Bill could enhance UK clinical trial regulation

European Pharmaceutical Review

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. If achieved, this would boost the UK’s competitiveness as a leading international site for trials.

Ethics 83
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Sharing data on human tissue availability across EU

European Pharmaceutical Review

Sharing data across borders ensures access to safe tissues and cells for human application is ethical and supply quality is adequate, said the Council in a statement. Improving communication between public health authorities was also a key aim.

Ethics 88
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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Ethical leadership is essential in promoting a culture of integrity within an organisation. How can this be mitigated?