Drug Development Immersion

  • Course Price: $795 USD
  • Course Run Time: 10 hours
  • Course Level: Level 1 - Foundational
  • Completion Period: 2 month

Drug Development Immersion is an intensive course that explores the regulatory, commercial, and scientific factors behind bringing a drug successfully to market. Discussion features both small molecule drugs and biologics. Our instructor illustrates the corporate decision-making process with personal accounts, giving participants unique insight into strategic development. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace. This is a recording of a Drug Development Immersion course given live.

Takeaways

1. Discuss the typical criteria for supporting first-in-human clinical trials.
2. Fluency in clinical development terminology and acronyms.
3. In-depth look at the FDA and EMA regulatory process.
4. Understanding the different aspects of clinical studies and their design.
5. Appreciation of post-approval drug safety monitoring.

Certificate Requirements
  • View all sections
  • Complete course evaluation
Section 1: Setting The Stage
Section 2: The Business Of Drug Development
Section 3: The Players: Who Is Involved?
Section 4: General Principles: Ethics And Risk
Section 5: The Regulatory Process
Section 6: Preclinical Development
Section 7: The Conduct Of Clinical Trials
Section 8: Clinical Development: Phase I
Section 9: Clinical Development: Phase II
Section 10: Clinical Development: Phase III
Section 11: Clinical Development: Phase IV
Course Evaluation
Certificate Requirements
  • View all sections
  • Complete course evaluation