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ESC Boston 2019 Schedule Viewer

 

Welcome to the Biomed Boston & ESC Boston 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Laura JeannelProgram Manager, EU MDRDePuy Synthes Companies (Senior Consultant)

Laura has 23+ years of Global Quality experience and is a seasoned GxP Quality Professional with 15+ Product Launches for biologics, vaccines, medical devices/combination products. She has worked in Europe for 15+ years including for major pharmaceutical companies Baxter/Baxter Biosciences, J&J (Janssen-Cilag) and SANOFI (Paris) and multiple small companies. She has directed over 60 global regulatory inspections (FDA/EU/RoW, Japan, Notified Bodies-BSI, TUV, etc.) and conducted PAI Readiness Training for over 50 companies.

Laura has experience building and remediating Quality Management Systems for large and small medical device companies, has directed several 13485:2016 certifications for leading companies including FDA Approval for complex products and genomic sequencing (FDA/EU, Canada, Australia and Japan markets), and continues to partner in key consulting firm with former Senior FDA and EU Regulators (pharma/medical device regulatory strategy and routine operations). She’s also part of the European and ISO Working Groups, and CMC Overview including NDAs, BLAs, IDE and PMA quality/regulatory strategies. She has experience authoring SOPs and for large and small clinical/commercial medical device companies, and is a current lead for Major EU MDR Project as Senior Consultant/SME for numerous Technical File updates for a global matrix program (resource/capacity planning, strategic modeling and hands-on review and oversight (partnered with ALKU staffing).

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