Regulatory strategy and CMC considerations are fundamental components of biological drug development and can
significantly influence the transition from discovery to clinical development. Early alignment on these aspects is critical for de-risking development programs and ensuring regulatory readiness.
In this webinar, Emma Eriksson and Marie Gårdmark, RegSmart, will present key strategic regulatory elements in drug development. The presentation is divided into two parts: the first will address the overarching regulatory strategy, while the second will focus on selected CMC aspects specific to biological drug development.
The BRIDGE webinar series is aimed at researchers, start-up and scale-up companies, as well as organisations within the innovation support system engaged in the development of biological products and pharmaceuticals.
BRIDGE Sweden is creating a platform to bridge the gap between expertise and research infrastructures in Sweden, supporting the development and commercialization of biological products and pharmaceuticals. Its goal is to strengthen Swedish Life science and advance the next phase of biological product development.
