Course

Drug Development

University of California San Diego

The Drug Development course from the University of California San Diego delves into the complex process of bringing drugs to market. With lectures from industry experts and faculty, you will gain comprehensive knowledge of clinical development stages, regulatory requirements, and study design methods.

Through an in-depth exploration of clinical trial phases, including Phase 1, 2, and 3, you will understand the critical aspects of safety, tolerability, and efficacy assessment in multiple therapeutic areas. Additionally, the course covers regulatory considerations for Investigational New Drug Applications (IND), New Drug Applications (NDA), and product labeling, providing a holistic view of the drug development process.

  • Gain insights from top industry professionals and faculty at UCSD
  • Explore the different stages of clinical development and regulatory requirements
  • Understand study design methods for assessing safety, tolerability, and efficacy
  • Get a comprehensive overview of drug approval processes and regulatory authorities

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Drug Development
Course Modules

This series of modules covers various aspects of drug development, including regulatory considerations, clinical trial phases, and industry insights. Gain comprehensive knowledge about the drug development process from this course.

Welcome!

The welcome module introduces the course and its key objectives, providing an overview of the comprehensive content covered throughout the program.

Regulatory Considerations When Filing an Investigational New Drug Application, Susan Trieu, Pharm.D.

Explore regulatory considerations for Investigational New Drug Applications, including insights into user fees, the FDA's impact on drug development, and interesting findings from ClinicalTrials.gov.

Clinical Study & Start-up Activities, Joseph Ma, Pharm.D.

Gain insights into clinical study and start-up activities, including ethical concerns, through a series of informative modules led by industry experts.

Clinical Trials: Phase 1, Yazdi Pithavala, Ph.D.

Delve into the critical Phase 1 clinical trials, understanding major safety situations and their impact on drug development in this comprehensive module series.

Clinical Trials: Phase 2, Kourosh Parivar, M.Pharm.

Understand the significance of Phase 2 clinical trials and their impact on drug development, including insights into changing medical technology and its influence on clinical studies.

Industry Considerations with Phase III Clinical Trials, Katie Lyons, Pharm.D. and Kelly Hogan, Pharm. D.

Gain industry insights into Phase 3 clinical trials, exploring considerations, globally influenced drug discoveries, collaboration stories, and the value of running studies in different countries.

New Drug Application, Filing, Product Labeling, Kelly Hogan, Pharm.D.

Learn about the New Drug Application filing process and product labeling considerations, including discussions on data sources, drug promotion, and its impact.

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