Good Clinical Practice

Refresher based on ICH E6(R3)

DIGITAL TRAINING COURSE

Your Course

Calling all Professionals being involved in planning, conduct and closure of Clinical Trials.
You have gained GCP Knowlege and want to Refresh it and apply it in Real-Life Examples.Understand the GCP Requirements and translate the Exercicen into your Daily Business.

Your Situation

You are constantly stressed and want to ensure Patient Safety and Data Quality ...

... but your Work and other Commitments are holding you back.

You want to comply with all GCP Requirements ... 

... but the Management of your Tasks leaves you little freedom.

You want to Get Trained on all GCP Updates ... 

... but you don't know How to Prioritize and Make your Day more Efficient.

You want to prepare a Robust Documentation for your Clinical Trials... 

... but you feel Overwhelmed by the Amount of Documents you need to prepare and maintain.

You strive to Increase your Productivity without Burning Out... 

... but you're Struggling to Manage all Tasks and Documents in Time.

Your Learning Objectives

How about you would be able to ensure Patient Safety and Data Quality by your way of working?
It just takes 1 day time.

  • Apply the GCP Principles for all your Tasks.
  • Define your Priorities with a risk-Based Approach and manage them effectively, resulting in less Stress and Overload.
  • Schedule 1 Hour per Day into your Calendar to complete the course in your own pace, keeping track of your Daily Business.
  • Balance your Time in such an optimal way that you can ensure adequate and timely Documentation as well as have enough time for your Tasks.
  • Use the learned Concepts so that you feel Productive and Energized throughout the day instead of being exhausted in the afternoon.
"Hello, I am Jana and a Clinical Trials Expert with over 15 years of experience in Ph I/II/III trials with Cell and Gene therapies as well as off-the shelf medication.
I recently enrolled in Clinical Excellence Training Academy GCP Refresher Course to get the latest updates on the ICH E6(R3) guideline. The course’s comprehensive structure and the expertise of the trainer, Jessica Cordes convinced me right from the beginning to enroll for this course and not another. The platform is user-friendly, making it easy to navigate through the modules and the course content is engaging, with a mix of video presentations, practical exercises, and quizzes that reinforced my learning. Completing the course, I feel confident to maintain all current ICH-GCP (R3) demands in my clinical trials. I am glad to be up-to-date again and having taken a course that allowed me to move forward in the speed my workload allowed. Sometime I only spent 10 minutes for one module, sometimes I completed multiple modules in a row. I can recommend this GCP Refresher Course to all clinical research professionals. It’s an excellent resource for staying current with regulatory standards. Overall, the GCP Refresher Course met my expectations. It provided valuable knowledge and practical tools that are essential for anyone involved in clinical trials."
Jana Hase
Clinical Trial Consultant, Cellex Cell Professionals GmbH

"Dear Jessica,
thank you for giving me the opportunity to provide you with a testimonial on the GCP refresher course. I completed today the course and I have to see, often GCP trainings feel very dry, but your video training in which you explain the individual modules is very refreshing. The fee is reasonable for a refresher and overall it is a very well-rounded package. Always again."
BEHZAD KHARABI, MD
Clinical development consultant, KHARABI CONSULTING

Master complex Clinical Trials
and ensure GCP Compliance

My promise to you:

You will be able to train with many practical exercises which illustrate how to apply the updated GCP requirements in real-world scenarios AND you will be able to manage your daily tasks.

You don't believe me when seeing your calendar?

I do understand. I feel the time pressure and continuous demanding expectations by myself. That is why I switched to digital training courses, allowing a self-paced learning.

Understand the lastest GCP Updates

Get a Comprehensive Overview of all Key Elements based on the  ICH E6(R3) guideline.

Enhance your Sponsor Oversight

Implement Risk-Based Sponsor Oversight and Focus on the Critical Aspects by Accepting minor Risks.

Avoid Inspection Findings

Apply the Practical Learnings to your Daily Business and achieve Patient Safety and Data Integrity.

Your Time Investment

  • Over 3 hours of Video Presentation
  • Over 1,5 hours of Practical Exercises
  • Around 10 min Quiz after each Module
  • Roughly 2 min Learning Diary after each module

Your Trainer

Hello, it’s me, Jessica Cordes, a Clinical Operations Enthusiast.

Throughout my 15-year journey in clinical drug development, I've been captivated by a complex clinical trial environment, particularly in addressing the critical needs of patients battling blood cancer and solid tumors.
In my leadership roles within Clinical Operations over the past 6 years, I've cherished the collaborative spirit that fueled our pursuit of innovative cell and gene therapies, an environment with even more regulatory requirements.
Witnessing the convergence of expertise and empathy, I didn't just develop drugs; I worked with truly inspiring and cohesive teams.

Since many years I am enjoying to give my experience and knowledge to the industry; trying to make a difference to the usually boring GCP trainings.

Jessica Cordes

Senior Consultant | Trainer

Your Benefits

1 - Efficient & Flexible

You have the opportunity for a Self-Directed Learning. You can progress at Your Own Pace without being tied to fixed training times.

Compared to traditional classroom training, you Save Time and Travel Costs.

2 - Updated & Relevant

You learn based on the Updated GCP guideline.
You train with Practical Exercises the application of GCP in Real-World Scenarios.

3 - Interactive

The exercises come along with different Types of Interaction to give you a Learning Experience.
Additionally, you can Connect to other Learners via a Community.

4 - Certified

After each module you comple a Quiz.
At the end of the course, you will receive a Training Certification.

Your Course Agenda

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Your Guarantee

You will receive a training certificate that is compliant with inspector's expectations.
Updates
The course content is regularly updated to reflect the latest developments, including the Declaration of Helsinki (2024) and ICH E6(R3) (2025).

Frequently asked Questions

How much time do I need to plan for the course?

Overall, please plan approximately 4 hours to complete this course.
You can stop and continue the course whenever you want to allow managing your daily tasks, transfering the practical examples into your clinical trial and making breaks as well.

Is the GCP Refresher course worth it?

Absolutely. You get a self-directed learning experience and can progress on your own pace. You learn the GCP updates according to ICH E6(R3) not only frontal but train your learnings with real-world scenarios. Beside the interactive learning you are able to connect to your peer learners via the Clinical Excellence Training Academy (CE-T-A) Community.

I doubt that the course will not be boring. How can I be sure?

It's natural to be skeptical. You've probably already done many boring GCP Refresher. Me, too.
My GCP Refresher is based on more than 15 years of Clinical Operations experience and (unlike other courses) provides many interactive exercises and learning diaries.
Consequently, you will enjoy this course.

What guarantee do I have that the course is up-to-date?

I give you my 100% satisfaction guarantee.
This means that I am reviewing regularly the course content for any updates.
It covers the final ICH E6(R3), including the final Annex 1 and draft Annex 2, as well as teh updated Declaration of Helsinki (from 2024).

How long do I have access to the course?

You geet access to the course for 9 months.
So, once purchased, you'll have plenty of time to access and implement all the concepts and materials.

The program is designed in such a way that you only need 1 week for completion if you invest 30-45 minutes of time per day.

But of course, you can work through the program at your own pace and refer back to it whenever you want to look something up.
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