RNA and Lipid Nanoparticle Excipients for Drug Product Manufacture - a Regulatory Perspective
（和訳：「レギュラトリーの観点から見た医薬品製造用のRNA原薬と脂質添加剤」）

発表要旨

RNA as actve ingredient in drug products has become increasingly important during the recent years. Lipid nanoparticles (LNPs) have been demonstrated as suitable drug delivery technology to protect mRNA against degradation in body fluids. This webinar will review the current basic regulatory requirements for these applications for RNA as active substance and LNP-excipients from early development to clinical application with focus on European and US regulations.

プロフィール

Ulrich Reichert heads the "Regulatory Management - CDMO and Bioprocess Materials” organization of the Life Science business of Merck KGaA, Darmstadt, Germany. He is responsible for registration of APIs and excipients with health authorities and preparation of CMC documents for customized modalities. Ulrich is pharmacist by training, holds a PhD and a Master of Drug Regulatory Affairs, and has more than 20 years of experience in quality and regulatory requirements for raw and starting materials in the pharmaceutical industry.