GCP – Good Clinical Practice

Categories: Clinical Trials, Professional training
SKU: 19069D
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Dates:  Coming soon.
The course will be scheduled based on the level of interest

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    Course location: Engineering School building, 30 Haim Levanon St., Tel Aviv
    Duration: 3-Day Course
    Hours: 17:00 - 20:30
    Credits: 3
    Course Language: עברית
    Course price: 1,850 NIS Including VAT

    Have a question? We have the answer

    Issues to be covered

    • Introduction: concepts, terms, definitions
    • Regulatory Requirements
    • The Israeli Ministry of Health
    • USA (FDA)
    • European Community (EMA)
    • GCP – Good Clinical Practice: the basic guidelines and rules for conducting a clinical trial around the world (ICH GCP E6R2)
    • Quality in clinical trials
    • Safety in clinical trials
    • Risk Management
    • Informed Consent, Flow of Information
    • Ethics

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