Recorded Drug Development Immersion

  • Course Price: $895 USD
  • BIO Member Price: $795 USD
  • Course Run Time: 9 hours
  • Course Level: Level 1 - Foundational
  • Completion Period: 3 month

This is the recorded Drug Development Immersion course with 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 a nine-hour, interactive course that explores the regulatory, commercial, and scientific factors needed to bring a drug successfully to market. The discussion features both small molecule drugs and biologics. Our instructors illustrate the corporate decision-making process with personal accounts, giving participants unique strategic development insights. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace. 

Drug Development Immersion was developed for the non-science professional who works within or services the biopharma industry and needs to become familiar with the preclinical and clinical development process.

Takeaways

1. Fluency in essential terminology and acronymns used in drug development
2. In-depth look at the FDA and EMA regulatory process and sponsor interactions
3. Criteria for preclinical studies to support first-in-human clinical trials
4. Rationale, special considerations, and study design for both traditional and non-traditional clinical trial phases
5. Understanding of the launch process, life cycle management, and post-approval drug safety monitoring

View Outline
Certificate Requirements
  • View entire course
  • Read all articles
  • Answer all knowledge check questions
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
LinkedIn Certificate Demo
Certificate Requirements
  • View entire course
  • Read all articles
  • Answer all knowledge check questions