• An expensive and risky proposition
• Regulations
• Functional areas
• Workstreams
• Timeline
• Objectives and key players
• The IND and CTA
• Phase 1 studies
• Phase 1 decisions
• Regulatory activities
• Clinical R&D and biostatistics activities
• End of phase 2
• Phase 3 activities
• Safety reporting requirements
• Regulatory review
• The Common Technical Document
• Objectives of phase 4 and lifecycle management
• The product lifecycle
• Post-approval activities and decisions
• Lifecycle management
• Case studies
• Reviews

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

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

  • Describe the use of a Target Product Profile (TPP) as a tool in designing a drug development program
  • 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 Pre-Clinical Phases: Upon completion of this module, learners should be able to:

  • List discovery activities
  • Recognize how toxicology studies are conducted
  • Identify drug substance production and drug product formulation activities
  • Determine the functions of good manufacturing and laboratory practices
  • Recognize how biomarkers and surrogate endpoints are used

  Module 3: Drug Development Phase 1: 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: Drug Development Phase 2: Upon completion of this module, learners should be able to:

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

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

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

  Module 6: Drug Development Phase 4 and Lifecycle Management: Upon completion of this module, learners should be able to:

  • List the objectives of Phase 4 studies and lifecycle management
  • Describe the stages of the product lifecycle
  • Outline post-approval activities and decisions that can grow or maintain market share by capitalizing on product or patient characteristics