Parenteral Drug-Device Combination Products – Data Package, Integrated Control Strategy, and Platform Approach for Successful Submissions

3/21/2022 11:35 - 12:05

Health Authority expectations in USA, Europe, China and around the world have risen strongly. Extensive data requirements and statistics on product robustness and user capability even under worst-case conditions require a change in mindset from the very start of product design, applying thorough scientific and engineering principles, true cross-functional collaboration, an integrated drug-device control strategy, and smart platforming, to enable successful market registrations, competitive products, and reasonable use of resources. Examples will be provided mainly for prefilled syringes with needle-safety systems and autoinjectors, the principles apply across all combination products.

Corinna Sonderegger, Executive Director Competence Center, Global Device & Packaging Development (GDPD), Novartis