GCP Refresher / Update Live Webinar

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It’s a regulatory requirement to have regular GCP training.  It’s important to have a refresher on the requirements everyone should be familiar with, but it’s also important to keep up to date with changes to the requirements.  Our GCP Update webinar does exactly this and is revised every time we deliver it to ensure we cover the latest updates.

Who is it suitable for?

This webinar is suitable for those who need a refresher and update on GCP for clinical trials, for example Clinical Operations, Medical Advisors, CRAs, CTAs, Clinical Project Managers, Investigators, Research Nurses, Study Site Co-ordinators, Ethics Committee members. 

Objectives:

To provide delegates with an understanding of:

  • The regulatory framework governing clinical trials in the relevant region(s)
  • Changes in regulatory requirements in the last 12 months.
  • Implication of changes on clinical trial conduct

Example Content:

ICH GCP Introduction / Refresher and Update

  • ICH E6(R2) Refresher 
  • ICH E6 the future – proposed changes and implications
  • ICH E8 update

EU Regulatory Environment refresher and update

  • Eudralex Volume 10 overview
  • New EU Regulation on Clinical Trials (536/2014)
  • New EU Clinical Trials Guidelines

UK Clinical Research refresher and update

  • Update on HRA approval
  • Brexit latest

US Clinical Research refresher and update

  • Key requirements of relevant 21CFR Legislation
    • 21CFR part 11
    • 21CFR part 50
    • 21CFR part 54
    • 21CFR part 56
    • 21CFR part 312
  • Update on FDA Guidances
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