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The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

PharmaTech

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Safety 98
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Draft regulatory guidance on personalised cancer therapies published

European Pharmaceutical Review

This guidance aims to streamline access pathways for patients, without compromising on the safety of these personalised immunotherapies. To support this endeavour and steer the final guidance, the agency launched an eight-week consultation on 3 March, which will run until the end of next month.

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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

This dual-layer certification process can create significant delays, as each framework involves extensive assessments for safety and performance under separate requirements specific to medical device and AI-specific criteria. Internet] intersoft consulting. Alex has a BSc in Human Genetics. References 1. Available from: [link] 2.

Medical 105
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Digital health is overrated but there is a future

World of DTC Marketing

It is essential that the ground rules for these AI tools include firm parameters that seek to prioritize patient safety. Data used for purposes other than those intended by the patient are potentially a safety risk to that patient and should be treated as such. It could accelerate the time between consultation and referral/treatment.

Doctors 291
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Cerner Enviza and FDA partner to develop AI drug safety tools

Pharmaceutical Technology

Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.

Safety 59
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Innovative Approach to Sales Compensation Evaluation: SCOR³ES®

The Marketing Advantage

Request a Free Consultation Request a Free Consultation 2 Name * First Name Last Name Company * Title Email * Phone (###) ### #### Message Thank you! S SAFETY NET Is the sales forceand companyprotected should something outside of its control occur in the marketplace? A member of our team will be in touch shortly.

Sales 52
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New mass spectrometry Chapter could “revolutionise” biopharma quality assurance

European Pharmaceutical Review

It is an industry-wide challenge to control [host cell proteins] HCPs to ensure the safety and quality of biopharmaceutical products” stated Derrick Zhang , Senior Scientist, US Pharmacopeia. This follows an announcement by USP about its intent to revise General Chapter <1132.1>