Menu Back toDrug Development and Life Cycle Management eLearning Program

Drug Development and Life Cycle Management eLearning Program


Overview

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed. This program will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and potentially minimize the risks associated with shepherding a new drug candidate through the development process.  At the end of the program, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs in the US and Europe, and to expand the life cycle of in-line products.

The online program includes six self-paced modules that can be accessed 24 hours a day, 7 days a week. Modules do not have to be taken in one sitting; users can start/stop at any time and begin where they left off. Users will have one year to complete the modules and continuing education credits are offered. These six modules will take approximately 6 hours to complete.

Featured topics

  • Phases of drug development
  • Functional areas involved in the drug development process
  • Workflow for bringing a new drug to market
  • Key objectives and activities of each phase
    • Safety reporting requirements 
    • Regulatory submissions and review processes in US and EU
    • Five stages of a product life cycle

Who should attend?

These modules are designed for individuals who are new to, or changing roles, in the pharmaceutical and biotech industries.  These modules will also benefit professionals who work in the area of:

  • Clinical Research
  • Project Management
  • Administrative Support
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing
  • Medical Writing
  • Business Support

Learning objectives

Module 1: Overview of Drug Development: Upon completion of this module, learners should be able to:

  • Describe the phases of drug development
  • Identify the sources of drug development regulations
  • List the functional areas involved in the drug development process
  • Describe the workflow for bringing a new drug to market

Module 2: Discovery and Preclinical Testing Phases: Upon completion of this module, learners should be able to:

  • Describe discovery activities
  • Explain how toxicology studies are conducted
  • Discuss drug substance production and drug product formulation activities
  • Describe good manufacturing and laboratory practices
  • Explain how biomarkers and surrogate markers are used

Module 3: Phase 1 Studies: Upon completion of this module, learners should be able to:

  • Outline the key objectives of Phase 1 studies
  • Describe the regulatory submissions required for Phase 1 studies
  • List key activities that need to be completed before First in Human clinical trials can begin
  • Examine risk-return decisions involved in Phase 1 studies

Module 4: Phase 2 Studies: Upon completion of this module, learners should be able to:

  • Outline the key objectives and activities of Phase 2 studies
  • Describe the regulatory activities and decisions that occur during Phase 2 studies
  • Examine risk-return decisions involved in Phase 2 studies

Module 5: Phase 3 Studies and Regulatory Review: Upon completion of this module, learners should be able to:

  • Outline the clinical study activities of Phase 3 studies
  • Explain the safety reporting requirements
  • Discuss the regulatory review process in the US and Europe
  • Examine components of the CTD

Module 6: Phase 4 Studies and Life Cycle Management: Upon completion of this module, learners should be able to:

  • List the key objectives of Phase 4 studies
  • Describe the five stages of a product life cycle
  • Outline how to grow or maintain market share by capitalizing on product or patient characteristics


 

Contact us