Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices. This Food and Drug Administration (FDA) Good Clinical Practice (GCP) course reviews all phases of clinical drug development and focuses on best practices to remain compliant with GCP guidelines and FDA regulations.
Biosimilars: Understanding Regulatory Challenges. This course examines the Chemistry, Manufacturing and Controls (CMC), nonclinical and clinical regulatory requirements from FDA, European Medicine Agency (EMA), and World Health Organization (WHO) for biosimilar biological yrdyrmmd.
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