Mark serves as an independent consultant to the Pharma and Medical Device industries via his company Corvus Device Ltd.
He has over twenty years of experience in Medical Device, Drug Delivery Device and Combination Products across Development, Operations, Regulatory/Quality Compliance and product maintenance – from a range of roles with GSK, sanofi-aventis, Novartis and F. Hoffmann-La Roche.
Through his career to date he has been heavily involved in development of medical devices for combination products in several forms: syringes, pen injectors, auto-injectors, patch injectors, solution/suspension inhalers, multi-dose disposable and reusable dry powder inhalers, convenience kits, dispensers and special purpose applicators.
He has performed numerous due diligence and technical evaluations of novel delivery technologies; developed products through the full design control phases to market; and maintained marketed products.
Mark is a veteran of several successful IND/CTA/NDA/BLA/MAA submissions and approvals that have included drug delivery devices.
He has experienced many of the challenges associated with delivery device development and device product maintenance within large pharmaceutical companies and implemented Medical Device development guidance, quality systems and business processes.
Qualified with a Master’s Degree in Engineering Management from Loughborough University and a Bachelor’s Degree in Mechanical Engineering from London South Bank, he has maintained Continuous Professional Development with supplemental and progressive training in areas such as Technical, Manufacturing, Risk Management, Quality & Compliance, Technical Authorship, Project Management and Leadership.
He is an active presenter in the field and has co-authored a case study chapter for PDA’s 2013 publication ‘Combination Products: Implementation of cGMP requirements’, and worked with RAPS to co-author the introduction for their 2016 publication; 'Global Medical Device Strategy'.
Outline: this presentation will explore recent industry experience with US-FDA requests for Essential Performance Requirements.