Drug Development: From Research to Regulation
Navigate the complex journey of pharmaceutical development, from initial drug discovery through clinical trials to final regulatory approval processes.
Navigate the complex journey of pharmaceutical development, from initial drug discovery through clinical trials to final regulatory approval processes.
Gain a comprehensive understanding of the pharmaceutical industry's complex landscape in this 5-week course. Learn how economic, legal, and regulatory factors influence drug discovery and development. Explore the stages of drug campaigns, clinical trials, research costs, and the impact of patents and intellectual property. Discover the processes behind biological drugs, drug approval, and research pipelines in large pharmaceutical companies. This course is ideal for anyone interested in understanding the business aspects of drug development and the factors affecting new drug research.
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What you'll learn
Understand the process of determining unmet medical needs in drug development
Explore clinical trial stages and the information gathered at each phase
Analyze the research and development costs of advancing a drug from concept to market
Identify types of intellectual property relevant to newly marketed drugs
Examine different approval designations for drugs meeting critical unmet needs
Understand the approval process for generic drugs after branded drug exclusivity
Skills you'll gain
This course includes:
PreRecorded video
Graded assignments, exams
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Limited Access access
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There are 3 modules in this course
This course provides an in-depth look at the business side of the pharmaceutical industry, focusing on how various factors influence drug research and development. It covers the process of determining unmet medical needs, the stages of clinical trials, and the costs associated with bringing a new drug to market. Students will learn about intellectual property in the pharmaceutical context, including patents and trademarks. The course also explores different drug approval pathways, the development of generic drugs, and the roles of academia and biotech in drug discovery. By the end of the course, students will have a comprehensive understanding of the research pipelines in major pharmaceutical companies and the complex interplay between innovation and regulation in the industry.
Introduction to Pharmaceutical R&D
Module 1
Clinical Trials and Drug Economics
Module 2
Advanced Topics in Drug Development
Module 3
Fee Structure
Instructor
7 Courses
Medicinal Chemistry Expert and Educator at Davidson College
Dr. Erland Stevens is a distinguished faculty member in the Chemistry department at Davidson College, bringing a wealth of experience in medicinal chemistry and drug discovery to his role. After earning his Ph.D. from the University of Michigan at Ann Arbor in 1997, specializing in nitrogen heterocycles under Will Pearson, Stevens pursued postdoctoral studies at The Scripps Research Institute with K. Barry Sharpless. Joining Davidson College in 1998, he has since become a cornerstone of the chemistry program, regularly teaching medicinal chemistry to junior and senior undergraduates. Stevens' expertise extends beyond academia, as evidenced by his involvement in the continuing education program at GlaxoSmithKline's Research Triangle Park site in 2006 and 2007. His contributions to the field include authoring the textbook "Medicinal Chemistry: The Modern Drug Discovery Process," published by Pearson Education, which has likely become a valuable resource for students and professionals in the field. Stevens' research focuses on the synthesis and activity of antiviral nucleoside analogues, demonstrating his ongoing commitment to advancing pharmaceutical science. His career exemplifies the integration of academic research, industry relevance, and dedicated teaching in the field of medicinal chemistry.
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4.7 course rating
38 ratings
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