Webinar Replays


WR12 - Webinar Replay: Simplified and Harmonized Studies in the EU


Dec 19, 2018 3:21pm ‐ Dec 19, 2018 3:21pm

Expiration Date: Aug 22, 2019


Credits: None available.

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Description

This course will address the following topics: EU single authorization process for CT applications include 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 States, CMS, will review responsibilities, submissions and amendments; Investigator/sponsor roles related to CT activities; Key highlights surrounding study management, monitoring and reporting; and Authorization of investigational medicinal products for use in CTs. 

Learning Objectives

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

Speaker(s):

Credits Available


Webinar Replay: Simplified and Harmonized Studies in the EU Exam

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