The Association of Clinical Research Professionals

Webinar Replay: Simplified and Harmonized Studies in the EU

Pricing With Contact Hours

Member: $15 | Nonmember: $75

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires August 22, 2019.

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay Expires August 22, 2019.

Course Description

This course will address the following topics:

    • EU single authorization process for CT applications including two parts for scientific (Part I) and local/ethical considerations (Part II)
    • EU portal will be used for sponsor and EMA/MS communications
    • Member States and Concerned Member State(s) (CMS) will review responsibilities, submissions, and amendments
    • Investigator/sponsor roles related to CT activities
    • Key highlights surrounding study management, monitoring and reporting
    • Authorization of investigational medicinal products for use in CTs.

Upon completion of this Webinar, attendees should be able to:

  1. Understand Clinical Trial Applications and recognize investigator/sponsor roles related to CT activities
  2. Identify the requirements for conducting clinical trials in the EU and understand expectations for mandatory adherence by trial sponsors to the EU CTR Annexes
  3. Identify key highlights surrounding study management, monitoring, and reporting.