Pascal Winnen

BRCCH Collaborator

Pascal Winnen will be supporting the BRCCH-funded DAVINCI project with data management, GCP auditing and app interface development. He is the CEO of Hemex and has 20 years of experience in the quality assurance and operational management of global clinical trials within the pharmaceutical and medical device industry. He has expert knowledge of study feasibility and budgeting, protocol development, submissions to regulatory authorities and ethical committees, site and study management, monitoring and auditing, vendor management and study logistics, data management, archiving, reporting, publishing and filing for marketing approval for phase I, II, III and IV trials, product quality review, management of batch documentation and QP/FvP batch release. He is also a certified lead auditor and has performed numerous worldwide vendor audits against cGxP standards, including co-monitoring with CRAs. He has prepared and hosted multiple FDA, Swissmedic and EMA license-to-operate and pre-approval inspections. He has a BSc in telecommunication engineering and a MSc in clinical research in addition to regular quality assurance and regulatory training. He is also a serial entrepreneur in human and animal healthcare start-ups.

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