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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. How are regulatory guidelines adapting to this trend? References.

Ethics 87
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Securing the Safety Net in Drug Access and Support

PharmExec

A look at the intersection of rigorous compliance and ethical behavior: independent, charitable patient assistance foundations.

Safety 98
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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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

European Pharmaceutical Review

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. An opinion from a research ethics committee will remain a requirement for eligible trials, the agency added. Clinical trial amendment applications will not be eligible.

Ethics 96
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How Artificial Intelligence Could Be the Ultimate Weapon Against Cancer

MedCity News

By catching the disease early, patients have a higher chance of receiving successful treatment, and the cost of treatment can be significantly reduced. Personalized treatment plans: Treatment plans can vary widely depending on the type of cancer, the stage and the patient’s overall health.

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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. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care.

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Research integrity: five tips for authors, editors and reviewers

Clarivate

If the research is used to inform policy decisions around, food safety and public health, for example, then misleading and false research can risk people’s lives. Ethical publishing: an introductory course. Share your knowledge around research ethics with your peers, for example by presenting a seminar at your institution.

Ethics 106