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Project Management of Clinical TrailsPlanning & practical aspects of clinical projects

Conducted by: גב' Hilla Debby
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Efficiently overseeing a clinical trial has the potential to expedite product approval, resulting in a quicker market entry. This course offers the fundamental aspects of planning and managing clinical trial projects, covering the development of trial objectives, formulation of plans and timelines, allocation of staff and budgets, site selection, and engagement with various stakeholders including physicians and regulatory bodies. Using...Continue reading

Efficiently overseeing a clinical trial has the potential to expedite product approval, resulting in a quicker market entry. This course offers the fundamental aspects of planning and managing clinical trial projects, covering the development of trial objectives, formulation of plans and timelines, allocation of staff and budgets, site selection, and engagement with various stakeholders including physicians and regulatory bodies. Using case studies and interactive discussions, this course aims to assist participants in understanding the practical aspects of a managing a clinical projects.

Pre requisite:

  1. Practical experience of at least two years in the field of clinical research
  2. Familiarity with ICH-GCP / ISO 14155.
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Dates: 
  • 17/06/2024
  • 20/06/2024

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    Course location: Zoom Course
    Duration: 1-Day Course
    Hours: 10:00 - 13:00
    Credits: 1
    Course Language: עברית

    Course price: ₪2,100 + VAT
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    Issues to be covered

    Project Management means overseeing all aspects of the trail life cycle.

    • Product life cycle and the importance of clinical trials
      • Sponsored vs. independent studies.
    • Basic of good clinical practice – GCP
    • Planning and designing a clinical trial
      • Key considerations in protocol objectives and various study designs
      • Project stakeholders
      • Protocol development
      • Budget timelines and resources
    • Clinical Trial conduct
      • Site selection, monitoring and Patient enrolment
      • Data management Adverse event reporting
      • Communication with internal and external personnel
    • Overview of regulatory requirement – how to prepare for an audit (US and EU)
    • Closeout activities
      • Clinical study report
      • Manuscript preparation

    Who should attend

    • Clinical Project Managers
    • Clinical Research Associates – CRAs
    • Clinical/Medical Research Scientists
    • Research Nurses/coordinators

    Benefits to the Participants

    • Skill Enhancement: Participants are acquiring a comprehensive understanding of the key principles and practices in clinical research and trial management. Attendees acquire new skills and enhance existing ones, making them more effective in their roles.
    • Career Advancement: The course enhances professional development and hence career advancement opportunities
    • Effective Protocol Design: The course equips participants with the knowledge to develop well-structured protocols, leading to more successful and scientifically sound studies.
    • Efficient Trial Conduct: Learn best practices for site selection, patient enrollment, and monitoring during the trial and by that an efficient conduct of clinical trials.
    • Preparation for audit- Covering the essentials of regulatory compliance, helping participants be prepared for inspections.

    About The Lecturer

    Hilla Debby
    Hilla holds an M.Sc. from the Faculty of medicine Technion
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    תחזוקת מערכת האיכות בזמן מלחמה QMS

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