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Good Clinical Practice R2 addendum only

  • Training

  • 90 Minutes
  • Compliance Online
  • ID: 4900013
This webinar will provide you with a recap into what is Good Clinical Practice (GCP) and help you understand why the Revision 2 addendum was required. It will allow you to understand the implications of this revision for clinical research trials and gain the knowledge to fully comply with ICH GCP. It will provide an overview of what additions were added in the R2 addendum.

Why Should You Attend:

Do you work in the clinical research industry? Is your knowledge and training on the guidance up to date and complete? Since the release of the ICH GCP addendum referred to as R2 there have been many changes made to the way clinical trials can be conducted. If individuals are not up to date with these requirements it will leave trials open to serious audit findings.

All individuals must hold a current ICH GCP certificate to work within clinical trials and if this hasn’t been completed since the R2 addendum was released you are no longer current.

Areas Covered in the Webinar:

What is GCP?
  • Recap on GCP guidelines
  • Why R2 revision was needed
  • Implications of update on future conduct of clinical research
  • Additions added to GCP in this addendum
  • Exercise on audit findings related to GCP
  • Examine reasons why this addition was important
  • Summary and conclusion

Who Will Benefit:

Clinical Research Professionals such as:
  • Clinical Research Associates
  • Clinical Project Managers
  • Clinical Trial Assistants
  • Clinical Research Organisation
  • Sponsors
  • Investigators
  • Research staff
  • Research nurses
  • Doctors
  • Dentists
  • Opticians
  • Pharmacists
  • Clinical research trainers
  • Site staff

Speaker

Linda Hopkinson

Course Provider

  • Linda Hopkinson
  • Linda Hopkinson,