EAPB: Regulatory Aspects for Biopharmaceuticals - "QbD"

In contrast to many other sciences, the biopharmaceutical sciences are heavily impacted by national and international regulations so that developers and manufacturers of biopharmaceutical drug substances and drug products need profound knowledge of the current drug regulations in the field as well as of current regulatory opinions.
On the other hand, drug regulations must consider what is scientifically feasible and sensible. This balance is achieved the best by frequent exchanges between industry, academia and regulatory bodies.

The SIG Regulatory Aspects for Biopharmaceuticals wants to give this exchange room and targets at taking up current hot topics in presentations and discussion forums. The aim of this workshop is to bring together experts on regulation and experts from academia and industry in order to share experiences and discuss different opinions on two selected current hot topics: "Quality by Design" and "Subvisible Particles".