Ask the Expert: EU Data Protection
April 24th 2025In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.
DCAT Week 2025: Maintaining Aseptic Integrity and Stability in Sterile Injectable Manufacturing
March 18th 2025Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the challenges with maintaining aseptic integrity in the manufacturing of sterile injectable pharmaceuticals.
Behind the Headlines: GLP-1 Shortage, Nobel Prize, RNA Editing, and More
October 24th 2024Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.