Drug Development Process | CTDM.X418

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The development of a new drug is a complex, lengthy, and expensive process. Since regulatory approval is required before a company can bring a drug to market and generate revenue, it remains one of the riskiest endeavors in the biopharmaceutical industry

In this course, you will explore the drug development process—from preclinical efforts to evaluate a drug's pharmacologic properties for safety and efficacy to the clinical trials required for regulatory approval. You will examine the objectives, mechanics, and ethical considerations of testing investigational drugs in human clinical studies. The course also covers how the U.S. Food and Drug Administration (FDA) reviews new drug applications and the post-approval requirements imposed on biopharmaceutical sponsors.

Through real-world case studies, you’ll gain insight into the science and regulatory frameworks guiding drug development, as well as the challenges biopharmaceutical professionals face in bringing a new drug to market. These case studies illustrate the complexities of the process, providing a practical perspective on the regulatory and business considerations influencing the industry.

Designed for professionals across disciplines who are currently working in—or considering a move to—the biopharmaceutical industry, this course offers a foundational understanding of drug development and equips students with the knowledge needed to navigate the biopharmaceutical landscape.

Learning Outcomes
At the conclusion of the course, you should be able to

• Explain the key steps in drug development, including how investigational drugs advance through preclinical and clinical stages.
• Recognize the different phases of clinical trials, including their objectives, structure, and the types of data generated.
• Discuss the oversight role of the FDA, including its regulations governing clinical trials, pharmaceutical law, compliance, Good Clinical Practice, ICH Guidances, and bioethics.
• Develop critical thinking skills to assess the challenges biopharmaceutical companies face in drug development.
• Evaluate the role of the biopharmaceutical industry in society, balancing its benefits with informed critique of its business model.

Topics Include

• Drug safety, efficacy, risk-benefit analysis, pharmacokinetics, metabolism, and pharmacodynamics
• Clinical trial design, objectives, ethical considerations, and the interpretation of trial data
• The regulatory framework surrounding clinical development, including the FDA’s role in reviewing drug applications, enforcing pharmaceutical regulations, and conducting inspections
• The mechanics of conducting a clinical trial from start to finish
• Job opportunities and career pathways in the biotech and pharmaceutical industry

Professional Credit

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114, 30.0 hours.