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Sie suchen in allen Bereichen nach dem Autor Jasper C.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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Adaptive Learning Compliance
Rubrik: GxP
(Treffer aus pharmind, Nr. 08, Seite 596 (2026))
Adaptive Learning Compliance / From Documented Trainings to Evidence of Competence in the Pharmaceutical & Medical Device Industries · Jasper C, Brown M · PTS Training Service
Adaptive Learning GxP Training AI Compliance The pharmaceutical and medical device training model used today is organized around an event-and-record logic. Instructor-led or read-and-acknowledge sessions are scheduled; completion is logged in an Learning Management System (LMS) or on a form, and annual refreshers are triggered by calendar dates. Regulators’ expectations have been shifting. The 2014 revision of EU GMP Chapter 2 introduced the requirement that practical effectiveness of training is assessed periodically [ 1 ]. ISO 13485:2016 requires manufacturers to evaluate training effectiveness using a methodology proportionate to the risk associated with the work [ 3 ]. While 21 CFR Part 211 contains no ...
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Use of synthetic data in AI development
Rubrik: IT
(Treffer aus pharmind, Nr. 05, Seite 471 (2024))
Bunzel G | Bertram K | Erdmann N | Heitmann M | Jasper C
Use of synthetic data in AI development / Insights from a case study in Cryo-EM image analysis · Bunzel G1, Bertram K1, Erdmann N2, Heitmann M3, Jasper C4 · 1ATEM SD GmbH, Remscheid und Deloitte Wirtschaftsprüfungsgesellschaft GmbH, Düsseldorf und d-fine GmbH, Frankfurt und Charles River Microbial Solutions Germany GmbH, Kaarst
Unsupervised Machine Learning Synthetic Data Validation Adeno-Associated Viruses (AAV) Cryo-EM Personalized medicine and gene therapy are widely seen as mega trends in the pharmaceutical industry that will revolutionize the industry in the next few years [ 1 ]. One key factor for the success of gene therapy and personalized medicine, has been the use of adeno-associated viruses (AAV) DNA vectors. The AAV process has enabled the development of multiple high-value therapeutics with multi-million revenues per dose, as shown in tab. 1 [ 2 ]. Product Supplier Disease Area Licensed Price ($/dose) Lixturna Spark Therapeutics RPE65 retinal dystrophy 2017 0.85 million Zolgensma Novartis Spinal ...
