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ICH and harmonisation of requirements for clinical research
Course Summary
Good Clinical Practice (GCP) is an international ethical, scientific and quality standard for the conduct of clinical research. Guideline E6, from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), often referred to as ICH GCP, specifies Good Clinical Practice. Compliance with ICH GCP is expected by regulatory authorities for the authorisation of clinical trials and the acceptance of their data in applications for marketing authorisation. In many countries, compliance with GCP principles is a legal requirement. In this course we describe the ICHโs role in the harmonisation of regulations, and we introduce its guideline E6 in its latest revision, E6(R3).
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s)โfor a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
โข Identify factors motivating demand for harmonisation of regulations for the drug industry and clinical research
โข Specify categories of guidelines developed by the ICH
โข Define ICH GCP and state its aims and applicability
โข Identify the latest revision of ICH GCP
Who will benefit from this course
This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.
Module Outline
Roles
Research, Regulatory, Compliance
CPD Points
No
Region
Level
Foundation
Course Study Time
Approx 15 minutes
USA, Europe, Other