Richard Jaenisch and Christopher Cole discuss AI in pharma manufacturing, covering learning steps, output evaluation, hallucinations, and FDA/EMA guiding principles.
PRAC-triggered post-authorization actions for cenobamate will cascade across SmPC, PIL, and controlled regulatory materials, ...
Laboratory testing validates low migration, low odor, and low VOC in clean, sustainable secondary packaging. Even paperboard ...
This week, PharmTech discussed proactive, data-driven contamination control, solving manufacturing hurdles, and the market entry of complex generics and biosimilars. This week, PharmTech took a look ...
Legacy web forms used for clinical trial recruitment, adverse event reporting, laboratory data collection, and regulatory ...
As a part of PDA Week 2026, Christopher Lewis, Emoja Biopharma and President of the Mountain States PDA Chapter, sat down ...
VP of operations and support at Kiteworks, with more than 20 years of experience in IT support and services. Since joining ...
Digital twins function as synchronized, real-time operational mirrors, where divergence from the physical process triggers ...
On April 9, 2026, Oxford BioTherapeutics announced a multi-year collaboration with Bristol Myers Squibb focused on the discovery and development of T-cell engager therapies for solid tumors. 1 ...
In part 3 of a 3-part interview, Susan Schniepp, Regulatory Compliance Associates Inc., makes a candid argument maintaining a ...
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