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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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Eli Lilly releases topline data for new oral GLP-1

European Pharmaceutical Review

“ ACHIEVE-1 is the first of seven Phase III studies examining the safety and efficacy of orforglipron across people with diabetes and obesity. Specifically, it reduced A1C by an average of 1.3 percent to 1.6 percent from a baseline of 8.0 This is based on the efficacy estimand applied to the trial data.

Safety 52
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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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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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EU Medical Device Safety Monitoring & Reporting Conference | October 26-28, 2021 | Berlin, Germany and Virtual

Pharma Marketing Network

Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape. Paul Malinovski, Head of QM & RA, Director BU Consulting , Pulmotree Medical GmbH. Pavel Kusnierik, Head of Regulatory Affairs , Contipro a.s. REGISTER TODAY.

Safety 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>