ICH GCP E6 Revision 2 Training

ICH GCP E6 Revision 2 Training

The fastest and most cost effective way to understand what ICH E6 (R2) is, why it is so important, and what it means to your organization.

This 90 minute online training course is targeted at individuals within Sponsor organizations and CROs that are involved in the design, conduct and reporting of clinical trials. Each course will be restricted in attendance in order to allow interactivity with the trainer. This training is designed to equip attendees with an appreciation of the changes, the rationale behind them and the knowledge necessary for successful implementation in their own environment.

Course cost is $299 per person. This includes the training event, a copy of the materials and a personalized certificate of attendance.

Next Available Course Dates:


Wednesday August 16th: 10am ET / 3pm BST

Thursday September 21st: 10am ET / 3pm BST

With the ICH GCP E6 Revision 2 changes now formally adopted it is important for organizations running clinical trials to understand the changes, the reasons behind them, and how they will be affected. It is also equally important to understand how to go about implementing those changes in an effective and efficient manner. This online, instructor led training course addresses all these key points, and will result in a signed certificate of attendance for all delegates.

Course Agenda

  • Introduction
  • Background and history ICH GCP changes
  • Current position of the Regulatory Authorities on the revision
  • Why is ICH E6 so important?
  • Why the revision?
  • What is the scope of change?
  • Key challenges/hurdles to overcome (interactive session)
  • How do we overcome those challenges? (interactive session)
  • Best practice process (interactive session)
  • Course wrap up

At the end of this session the participants will be able to:

  • Identify what has changed in ICH E6 Revision 2
  • Understand the reasons behind the change
  • Identify the greatest challenges to successful implementation
  • Define best practice implementation process based on practical experience

What sets us apart?

  • The course is very practical and delivered by QA professionals who are actively involved in implementing these changes
  • The course is interactive and gives you the chance to talk about your company’s needs and have your questions answered
  • You will receive a certificate of attendance, which is a first step towards achieving compliance
  • you will receive copies of the course materials for your reference after the training is complete

 

Step 1 – register by filling out the form below:

If you would like to register multiple people for your organization, please submit the form below with organizer contact information in place of the registrant and include the number of people registering in the “Special Instructions” section.  We will be in contact with you shortly to assist you with registering your organization.

If you have questions regarding the course or offerings, feel free to contact use using the form below, using the “Special Instructions” section for your questions.  We’ll respond to you shortly.

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