Validation Basics: A System Developer's Approach to Validation

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

NMPA’s Center for Drug Evaluation accepted Merck KGaA’s application for marketing authorization of pimicotinib as a Class 1 innovative drug for adult patients with TGCTs that require systemic treatment.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.

ICH Q6B provides expectations and a clear framework for the structural characterization of biopharmaceutical products.