Navigating Injectable Combination Device & Drug Product Regulations
Sponsored by: CordenPharma
- Drug Product Regulations
- Lifecycle Management
Date: 12 September
Time: 16:00 CEST / 15:00 BST / 10:00 EDT
How a Full-Service CDMO Supports Pharma
Many new pharma development projects and lifecycle management opportunities are exploring the integration of medical devices with drug products as the industry seeks more convenient, user-focused drug delivery solutions. These emerging solutions often fall under the designation of â€˜combination products’, where regulation, guidelines and applicable standards have evolved rapidly. Such a strong growth in this sector of the pharma industry has raised significant requirements on development, clinical supply, design transfer, risk management and commercial supply. For many pharma companies, the investment, facilities, equipment, process controls and challenges associated with meeting the new corresponding manufacturing requirements are still not fully understood, and can be therefore quite burdensome. Identifying and engaging established, competent and experienced external providers such as a global CDMO is an excellent alternative.
This Webinar will introduce the topic of combination device & drug products, provide an overview of the regulatory landscape with a particular focus on injectable drugs, and highlight how CDMOs such as CordenPharma are uniquely placed to help pharma Drug Developers, Regulatory, Clinical Supply, R&D and Tech Transfer Managers, External Quality, Business Development or Heads of Procurement & Supply Chain navigate the injectable combination drug product challenges ahead.
As participant, you will gain some key insights into understanding what IS and what IS NOT a combination device-drug product, some technical challenges for injectable PreFilled Syringes (PFS) & Autoinjectors, important aspects such as a sound injectable drug product strategy to consider before making your CDMO selection, and specific recommendations on finding solutions for injectable combination device-drug product challenges integrated with CordenPharma’s manufacturing capabilities.
REGISTER NOW for this specially-designed webinar given by two key speakers representing the exciting and dynamic combination device & injectable drug product industry from different angles: 1) as Company Director & Principal Consultant of Corvus Device Ltd., with over twenty years of experience independently consulting the Pharma & Medical Device industries on Medical & Drug Delivery Device and Combination Products in several forms across Technical Development, Operations, Regulatory/Quality Compliance and Product Maintenance, and 2) as Global Injectable Platform Director of CordenPharma International, with over twenty-five years of experience in injectable drug development & manufacturing, including combination products, under a full-service CDMO partner for small to large pharmaceutical / biotech companies.
Mark Chipperfield ,
Principal Consultant & Company Director
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 Technical 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.
Director, Global Injectables Platform, CordenPharma International
Fabio Stevanon has 25 years of experience in the pharmaceutical industry, and is currently the Global Injectable Platform Director at CordenPharma International. He has broad responsibilities to support and develop CordenPharma’s Injectable platform with the best capabilities, technologies and strategy for pharma market-specific needs. Prior to his current role, he held responsibility in Business Development, Supply Chain & Procurement within the Corden Pharma SpA Injectable facility at Caponago, IT, close to Milano. Before 2009, when the facility was still part of AstraZeneca, he worked as Supply Chain Director in a global project leader role on specific business areas related to lean activities & Business Process Reengineering. Fabio graduated with a degree in Engineering from Politecnico Milano in Italy.
Key Learning Objectives
- Understand what IS / what IS NOT a combination device-drug product.
- Gain insight into the major regulation landscape for combined drug & device products, including some technical challenges for injectable PreFilled Syringes (PFS) & Auto-injectors.
- Get an overview of how a sound injectable drug product strategy by a Full-Service CDMO helps navigate industry changes to support your drug development goals.
- Learn ways of partnering with a global CDMO to efficiently commercialize an injectable drug, with specific recommendations on finding solutions for injectable combination device-drug product challenges.
- Senior Staff within Injectable Field and Device/Combination Product Development
- Clinical Supply
- R&D Managers
- Tech Transfer Managers
- External Quality
- Business Development
- Head or Category Procurement