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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

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. London: EMEA; 1997 [cited May 2022]. ICH, 1999 [cited May 2022].

Ethics 98
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Janssen leads effort to cut waste in digital health devices

pharmaphorum

— Circular Digital Health (DiCE project) (@circular_health) October 13, 2022. The WEEE Forum notes that out of 16 ethical EU principles for digital health developed by the French Presidency of the EU, four focus on environmental sustainability, including eco-design, reuse, and recycling.

Leads 124
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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 105
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Improving Access to Medicine: The Role of Pharma Companies in Emerging Markets

PM360

In its 2022 edition, the Access to Medicine Foundation report 2 analyzed the access strategy of 180 products across the top 20 pharmaceutical companies, of which 102 are on the WHO essential medicine list. Access to Medicine Index 2022”: link In a shareholder meeting, Merck & Co. References: 1. Access to Medicine Foundation.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

On 14 July 2022, the European Commission published a proposal for a regulation on substances of human origin (SoHO) intended for human application. Covered SoHO activities are “action[s], or series of actions, that [have] a direct impact on safety, quality or efficacy of SoHOs.”

Safety 75
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Collaboration with Janssen and Eli Lilly to address lack of paediatric medications

Pharmaceutical Technology

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59
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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. The latest guidance was published just prior to the launch of ChatGPT in November 2022.