Webinar – Navigating Injectable Combination Products

Edition 5 / September 2019
Injectables Platform > Webinar: Navigating Injectable Combination Device & Drug Product Regulations

Edition 5 / September 2019

CordenPharma International Technology Platform Directors - Fabio Stevanon, Global Injectables Platform

Author
Fabio Stevanon

Director, Global Injectables Platform,
CordenPharma International


Webinar: Navigating Injectable Combination Device & Drug Product Regulations

CordenPharma Caponago aseptic fill & finish pre-filled syringe (PFS) robotized filling line weighing station close-up

CordenPharma Caponago (IT) Aseptic Fill & Finish Commercial Plant Pre-Filled Syringe (PFS) robotized filling line 1 weighing station.


Register Here for our Next Webinar
Navigating Injectable Combination Device & Drug Product Regulations
Thursday, September 12 at 16:00 CEST / 10:00 EDT
Many new pharma development projects and lifecycle management opportunities are exploring the integration of medical devices with injectable drug products as the industry seeks more convenient, user-focused drug delivery options. These emerging solutions assumed 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 led by Mark Chipperfield of Corvus Device Ltd., and highlight how CordenPharma’s Injectable Platform is uniquely placed to help pharma companies.

As a participant, you will:

  • >> 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 important aspects such as a sound injectable drug product strategy to consider before making your CDMO selection.
  • >> Learn ways of partnering with CordenPharma to efficiently commercialize your injectable drug, with specific recommendations on finding solutions for injectable combination device-drug product challenges integrated with our manufacturing capabilities.

Additionally you will get a thorough picture of CordenPharma’s injectable manufacturing capability to consistently support Aseptic Fill & Finish, as well as terminally sterilized drug products, by looking to recent investments and projected areas of growth for our injectable portfolio and capabilities.


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