Antibiotic Bootcamp - How Does a Molecule Become a Physical Medicine to be Given to a Human

This course covers the process of how a molecule transforms into a physical medicine for human use, emphasizing the significance of Chemistry, Manufacturing, and Controls (CMC). The learning outcomes include understanding the challenges in CMC, drug development phases, technical stage gate deliverables, GMP requirements, clinical development support, validation, and regulatory aspects. The course teaches skills related to drug requirements, supplying materials for clinical trials, planning, timeline management, and bridging the clinical program. The teaching method involves discussions led by industry experts and moderators. This course is intended for individuals involved in antibiotic development, pharmaceutical manufacturing, regulatory affairs, and clinical research in the field of antimicrobial resistance.