Pascal Winnen

BRCCH Collaborator

Pascal Winnen will be supporting the BRCCH-funded DAVINCI project with data management, GCP auditing and developing the interface for an App. He is the CEO of Hemex and has 20 years’ experience in quality assurance and operational management of global clinical trials within pharmaceutical and medical device industry: experienced in 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, products quality review, management of batch documentation, QP/FvP batch release. He is a certified lead auditor and performed numerous worldwide vendor audits against cGxP standards, including co-monitoring with CRAs. He prepared and hosted multiple FDA, Swissmedic & 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 a serial entrepreneur in human and animal healthcare start-ups.

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