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16 abr 2012 12:00 p.m. - 31 dic 2050 12:00 a.m.

Proven Strategies for Creating an Effective Clinical Research Program

Perspectiva general

With the pharmaceutical development process becoming increasingly competitive, complex, and global, it is necessary for clinical research professionals to clearly understand their roles and the roles of others they interact with. This knowledge helps them facilitate a pharmaceutical development process that is both timely and completed within budget.
Through interactive lectures and exercises, this online course will provide clinical research professionals with the knowledge and skill set needed to improve the pharmaceutical development process. Topics to be addressed include product development strategy, clinical trial management and development, project management, and quality concepts.
Course Level: Beginner

Lo que aprenderá

  • Product development plan
    • Target product profile
    • Multinational studies
    • Industry challenges
  • Clinical trial processes
    • Protocol development
    • Data collection methods
    • Informed consent challenges
    • Study reports
    • New drug applications (NDA)/common technical document (CTD)
  • Quality concepts
    • Site management
    • Auditing

¿Quiénes deben asistir?

  • Clinical research professionals working in these areas:
    • Clinical operations
    • Regulatory affairs
    • Data management
    • Project management
    • Medical writing
  • Site personnel
  • Medical monitors

Objetivos de aprendizaje

Participants who complete this course should be able to:

  • Discuss current practices and challenges in clinical trial management
  • Discuss the product development process and identify some challenges facing the industry in today’s environment
  • Discuss ethical principles of clinical research and applicable regulations
  • Outline the process for protocol development, case report form design, and preparation of integrated study reports
  • Demonstrate knowledge about concepts and functions associated with ensuring overall quality of studies
  • Apply clinical research planning principles

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