Mark A. Chipperfield, M.Sc, B.Eng.(Hons), AMIMechE, MTOPRA, Corvus Device - Qepler Summits And Conferences

Mark A. Chipperfield, M.Sc, B.Eng.(Hons), AMIMechE, MTOPRA

Company Director and Principal Consultant
Corvus Device
Holmes Chapel, United Kingdom
Corvus Device

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'.

Related Sessions:

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
CASE STUDY: Considerations for different types of drug/device Combination Products.
  • Some of the different ways of combining drugs and devices
  • Designation, classification and regulatory pathways
  • What applies where?
  • Some technical considerations
  • Clinical aspects to consider
View Details

Pre-Filled Syringes
Summit 2018

Enhance a fully integrated system approach for developing pre-filled syringes to maintain patient centricity.
  • 31 May 2018
  • Berlin, DE
  • Pharma
Day 1: Thursday, 31 May 2018
CASE STUDY: The impact of Medical Device Regulation (EU) 2017/745, Art.117.
  • General overview of US and EU regulatory landscape.
  • Product types and pathways.
  • Update on MDR.
  • Impact of Article 117 and the 'Notified Body opinion' requirement.
View Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
CASE STUDY: MDR and the impact on combined drug-device products - Latest Status.
  • Refresh the audience on the key implications of the MDR
  • Identify implications for both integrated and co-packed configurations
  • Share the latest status of guidance and industry discussions
  • Offer advice and suggestions for May 2020 readiness
View Details

3rd Annual Pre-Filled
Syringes Summit 2021

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 27 May 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 27 May 2021
CASE STUDY: Refresher on the regulatory, quality and technical expectations for PFS in EU/US
  • Regs: 21CFR4, 21CFR820, MDR
  • QMS: 21CFR820, ISO 13485, MDSAP
  • Tech: ISO, Agency requests
View Details

Medical Device
Regulations Summit 2021

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 08 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 08 July 2021
CASE STUDY: Implementation of the MDR and effect on Combination Products.
View Details