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 course is available as a self-serve eLearning package, or an instructor led webinar. The course is targeted at individuals within Sponsor organizations and CROs that are involved in the design, conduct and reporting of clinical trials.
Pricing includes the training event, and a personalized certificate of attendance for your training record.
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.
- 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
- How do we overcome those challenges?
- Best practice process
- Course wrap up
At the end of this session the participants will be able to:
- Identify what has changed in ICH E6 R2
- 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 RBM 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
- We have trained over 600 people across more than 50 companies
- We have had continued great feedback from trainees and have revised the materials more than ten time in line with new regulatory information and customer feedback