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Drug Development and Lifecycle Management

Drug Development and Lifecycle eLearning Program (all six modules!)

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. Upon completion, 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.

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Module 1: Introduction to Drug Development

Featured Topics:
  • An Expensive and Risky Proposition
  • Regulations
  • Functional Areas
  • Workstreams
  • Timeline
  • Review
  • Case Study
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Module 2: Discovery and Pre-Clinical Phases

Featured Topics:

  • Discovery activities
  • The Pre-Clinical Phase
  • Review
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Module 3: Drug Development Phase 1

Featured Topics:

  • Objectives and Key Players
  • The IND and CTA
  • Phase 1 Studies
  • Phase 1 Decisions
  • Review
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Module 4: Drug Development Phase 2

Featured Topics:

  • Objectives and Key Players
  • Regulatory Activities
  • Clinical R & D and Biostatistics Activities
  • Case Study Part 1
  • End of Phase 1
  • Case Study Part 2
  • Review
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Module 5: Drug Development Phase 3 and Regulatory Review

Featured Topics:

  • Objectives and Key Players
  • Phase 3 Activities
  • Safety Reporting Requirements
  • Regulatory Review
  • The Common Technical Document
  • Case Study
  • Review
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Module 6: Drug Development Phase 4 and Lifecycle Management

Featured Topics:

  • Objectives of Phase 4 and Lifecycle Management
  • The Product Lifecycle
  • Post-Approval Activities and Decisions
  • Lifecycle Management
  • Case Study
  • Review
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Digital Learning Catalog

DIA Learning: eLearning Soultions