DUBLIN--(BUSINESS WIRE)--The "Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course (Apr 23rd - Apr 24th, 2026)" training has been added to ...
In January 2020, the Food and Drug Administration (FDA) issued a guidance entitled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications ...
REGULATORY RELIEF FOR CERTAIN STATIONARY SOURCES TO PROMOTE AMERICAN CHEMICAL MANUFACTURING SECURITY
1. The United States relies on a strong chemical manufacturing sector to support industries like energy, national defense, agriculture, and health care. These facilities produce essential inputs for ...
The quality of a drug product is determined by the manufacturing line. Preclinical assessments and clinical trials provide an indication of safety and efficacy, but it is the manufacturing process ...
NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of ...
Techne, bioMerieux, Roche, Lonza Group, Miltenyi Biotec India and More Cell and Gene Therapy Manufacturing QC Market Cell and ...
Opportunities lie in enhancing regulatory compliance for biological drugs through specialized training. Courses focusing on CMC requirements, CTD quality modules, and molecule-specific strategies can ...
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