Laura Brown Training and Development
providing quality in-house training and QA solutions
 
Email : info@laurabrowndevelopment.com Tel : +44(0)1494 873 566
Laura Brown Training
 
International expertise for in-house customised technical and management skill training, and quality assurance audit for Pharmaceutical, Biotechnology, Medical Device and Healthcare organisations.
 
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GCP Update: GCP Update: Release of the new finalised ICH E6 R2 Good Clinical Practice Guideline.

This is the most important revision of GCP in over 20 years. The ICH guideline for good clinical practice E6 (R2) was finalised in November 2016 as an integrated addendum to ICH E6(R1):

Guidelines/Efficacy/E6/E6_R2__Step_4_2016_1109.pdf

The updated ICH GCP guideline has been revised to reflect and encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight and quality risk management.

This updated guideline provides a unified standard for the EU, US, Japan, Canada and Switzerland to facilitate the mutual acceptance of clinical data by the regulatory authorities in these regions. It will be essential to receive training on the changes to ICH GCP.

This updated guideline provides a unified standard for the EU, US, Japan, Canada and Switzerland to facilitate the mutual acceptance of clinical data by the regulatory authorities in these regions. It will be essential to receive training on the changes to ICH GCP.

The GCP update course will cover the new areas of the ICH GCP (R2) guideline which will including:

  • More efficient approaches to the design of clinical trial which are increasing being used
  • Sponsor oversight requirements
  • New methodologies and technologies used in clinical trials
    • risk-based approaches for setting up clinical trials
    • risk-based management
    • quality by design
    • quality systems in clinical trials and clinical studies
    • risk-based monitoring including centralized monitoring
    • Monitoring plans
    • Quality systems – including critical process and data identification
    • Electronic document management – the Electronic Trial Master File (TMF)
    • and… more

An example programme for an ICH GCP (R2) course that is available as a public course:
     https://management-forum.co.uk/product/details/2231/essential-gcp-ich-e6-r2-update

Other GCP courses are available covering the latest developments, refresher courses, overview courses and advanced GCP courses are available for CRAs/ monitors/ support staff/study site staff including Investigators/ and courses for specific disciplines including Regulatory Affairs and Pharmacovigilance staff

To find out more about any of these courses or to discuss how a course could be tailored to your specific needs, please contact Laura Brown at info@laurabrowndevelopment.com