Pharmaceutical Drug Discovery Process Online Course & Certificate

Duration:
20 contact hours
Used For:
2 Continuing Education Units
Course and Certificate:
$295


Pharmaceutical – Drug Discovery Process is a course that surveys how new drugs are discovered and brought to the clinic. This course provides a detailed picture of the complex and highly interrelated activities of the development cycle for drugs and biologics, from discovery to a successful commercialization.

This course is designed for professionals who require an understanding of the drug development process. The course is beneficial for anyone involved in the R&D process, in addition to marketing & sales personnel who need a foundation for the development process, and how the process affects sales and marketing strategies.

After completing Pharmaceutical – Drug Discovery Process, students will be equipped with a basic understanding of the following:

  • overview of the drug discovery process
  • steps from concept to commercialization
  • clinical trials
  • governmental interactions
  • intellectual property rights
  • packaging and labeling considerations

 

No prerequisites are required.

 

 Students will be assigned 5 homework assignments, and 1 final exam. 

  • Introduction to drug discovery and testing
  • Scientific, regulatory, and management framework
  • Pre-clinical study requirements for human clinical studies
  • Clinical phases for drug development process
  • Drug development economics
  • Clinical development cost-benefits
  • Discovery and development milestones
  • The IND Process
  • The NDA Process
  • FDA Interactions – Review and approval process
  • Intellectual Property (patents)
  • Government regulations
  • Code of Federal Regulations and ICH GCP
  • Clinical trial design
  • Drug labeling, marketing, and pharmacoeconomic studies
  • Project management – drug development process

 

 

 

 This course is Instructor-led and delivered through our award-winning online Learning Management System.