Regulatory Affairs Professionals Society
Developing the relevant set of potency assays for cell-based medicinal products comes with numerous challenges due to the complex nature of the products.
SCRIP Regulatory Affairs
Big data, mobile health and synthetic biology: An overview of some of the changes and measures taken by regulators as they strive to keep up with the latest developments.
An overview of the latest technology transfer strategies used by bio-pharmaceutical companies today.
An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.