Navigating Injectable Combination Device & Drug Product Regulations







I am Fabio Stevanon, Director of the Global Injectables Platform at CordenPharma International, a Contract Development & Manufacturing Organization (CDMO) which supplies Active Pharmaceutical Ingredients (APIs), Drug Products & Packaging for the pharma / biotech industry.

I am looking forward to our upcoming webinarNavigating Injectable Combination Device & Drug Product Regulations taking place on Sept 12thbecause it will give attendees a unique opportunity to hear from two speakers: Mark Chipperfield, Principal Consultant & Company Director of Corvus Ltd (one of the most skilled consultants in this industry) and myself, giving an overview of CordenPharma’s injectable capabilities & future strategy as a full-service CDMO.

We are very excited to take you on a journey through Injectable “Combination Products,” which were born out of the exploration on the part pharma companies to integrate medical devices with drug products in an effort to seek more convenient, user-focused drug delivery solutions. These quickly emerging solutions have caused regulations, guidelines and applicable standards to evolve rapidly, leaving many aspects of drug development and lifecycle management unsure how to proceed.

We hope you will learn 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 Pre-Filled Syringes (PFS) & Auto-injectors), get an overview of how a sound injectable drug product strategy by a CDMO helps navigate industry changes to support drug development goals, and 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).

Because this is such a hot topic right now, there has already been a lot of interest in the webinar. Being as this is a journey, we would like to also gain an understanding of the challenges that arise in developing injectable combination products, which could affect various roles within the Injectable field of Device / Combination Product Development including Managers, Supervisors, Senior Staff, Clinical Supply, R&D Managers, Tech Transfer Managers & External Quality, just to name a few.

We also want to learn what you are looking for from a global CDMO in connection with this topic. Your feedback will be extremely useful for us to fine-tune our future strategy to expand our Injectable Drug Product portfolio with a sound mix of technologies (as of now strictly aseptic Fill & Finish, lyophilization, terminal sterilization), balanced a good variety of finished dosage forms (e.g. suspension in near future) and product / container ranges (ampoules, all vial ranges, PFS & cartridges).


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