Navigating Injectable Combination Device & Drug Product Regulations

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 ‘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.

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.

Enjoy this specially-designed webinar given by two key speakers, representing the exciting and dynamic combination device & injectable drug product industries:

1. 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
2. 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.

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.