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Getting to grips with serious breach reporting: a new CTR requirement

Getting to grips with serious breach reporting: a new CTR requirement
Product Code: Getting to grips with serious breach reporting
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Getting to grips with serious breach reporting: a new CTR requirement

Wednesday February 16th, 2022, starting at 1pm GMT, 2 pm CET, 8am EST
75 min webinar, plus additional time if required to answer participant’s questions.

The EU Clinical Trial Regulation (CTR) enters force on 31 January 2022.
The CTR requires reporting of certain serious breaches of GCP, protocol and regulation.
New guidance was published in December 2021.
Find out what the requirements are, how and when to report and how the EU CTR requirements differs from the UK requirement.

  • What are serious breaches?
  • What are suspected serious breaches?
  • How and when do they need reporting?
  • Do you have a process in place?
  • Examples for those that need/do not need reporting.
  • What do the words mean: serious, significant degree, reliability and robustness of data?
  • What are the “Rights of a subject” that might be affected?

Webinar cost is based on number of connections, given below in GBP ex VAT

  • Individual connections (single participant): £100
  • Single connection with up to 5 people taking part – note one connection only): £150
  • Single connection with 5+ people taking part – note one connection only): £300
  • Special rates available for organisations needing multiple connections - please contact us for details

Don’t forget our range of online training and new electronic books – you will be amazed! Look at our e-brochure by clicking …

https://brookwood-global.com/Books/Brookwood-Global-Products-Brochure-2020

 

 

 

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