Recorded Drug Development Immersion

  • Course Price: $895 USD
  • Course Run Time: 10 hours
  • Course Level: Level 1 - Foundational
  • Completion Period: 3 month

This is the recorded Drug Development Immersion course which has the same content, interactive exercises, and course materials that are given in the live version. You have 3 months to view this course. 

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.

View Outline
Certificate Requirements
  • View all videos
  • Read all documents
  • Complete course evaluation
Viewing Course Materials
Setting the Stage
1
Knowledge Check
The Business of Drug Development
1
Exercise: Draft Label Activity
Knowledge Check
The Players: Who Is Involved
1
Knowledge Check
General Principles: Ethics and Risk
1
Knowledge Check
The Regulatory Process
1
Knowledge Check
Preclinical Development
1
Knowledge Check
Conduct of Clinical Trials
1
Knowledge Check
Clinical Development: Phase I
1
Knowledge Check
Clinical Development: Phase II
1
Knowledge Check
Clinical Development: Phase III
1
Exercise: Key Stage Risks Activity
Knowledge Check
Clinical Development: Phase IV
1
Knowledge Check
Course Evaluation
Linkedin Certificate Demo
Certificate Requirements
  • View all videos
  • Read all documents
  • Complete course evaluation