Virtual Audits

The webinar on Virtual Audits will present the current regulatory expectations, benefits and challenges of virtual auditing and will share expertise on the planning, preparation, performance and reporting for a virtual audit.

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Good Statistical Practices to Tackle the lack of Reproducibility from Discovery to Clinical Research

For 15 years the scientific literature repeatedly underlines the important lack of reproducibility and replicability of studies in biomedical and psychological research. As a consequence, several scientific organizations (journal, scientific societies, universities, national agencies) have identified some root causes to this issue and proposed good research practices to improve the reproducibility of the results.

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Early-Phase Modelling – Estimating the Costs and Effectiveness of a Pharmaceutical before Clinical Trial Data is available

This webinar offers an overview of the benefits early-phase, health-economic modelling can provide, at a stage when the outcome of the product development program is still largely unknown. Early-Phase Modelling balances between accuracy and manageability, and represents an easy to grasp, conceptual overview of your product and its potentials regarding reimbursement.

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ClinPHLEX – A Strategically-Focused, Cross-Functional, Clinical Development Partnership

ClinPhlex is a global, cross-functional, clinically-focused team that works in close collaboration with a client to  provide innovative, customized, efficient, strategic and tactical solutions to optimize and de-risk development. Our expertise and global experience in clinical development, clinical-regulatory strategy, biostatistics and biostatistical regulatory strategy, clinical and translational pharmacology as well as clinical research/operations and program management allow ClinPhlex to evaluate and improve your current position.

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An Overview to Non clinical testing: why? when? what?

Why is non-clinical testing needed? This webinar will deliver you an overview of the non-clinical framework in the EU. Furthermore different products are shown as examples to illustrate the process of non-clinical testing in praxis.

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Data Science: Strategy For A Successful Quality By Design Implementation

Bruno Boulanger holds a PhD in Experimental Psychology from the University of Liège (Belgium). Since 2000, Dr. Boulanger is Senior Lecturer at the Université of Liège, in the School of Pharmacy, teaching Design of Experiments and statistics. He organizes and contributes to Non-Clinical Statistics in Europe.

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