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Navigating ICH GCP E6(R3) – Enterprise

Are you ready to master the latest changes in the pharmaceutical industry? Our comprehensive online course is designed to guide you seamlessly through the transition from ICH-GCP E6(R2) to (R3). Whether you’re a professional in the pharmaceutical sector, a clinical researcher, or a regulatory affairs expert, this course is tailored to elevate your understanding and application of the new ICH guidelines.

NAVIGATING ICH GCP E6(R3)

What You’ll Gain:

  • Get ready for (R3) implementation: Get the latest changes from (R2) to (R3) and get ready to implement the new elements of the revised guideline.
  • In-Depth Understanding: Dive into the nuances of the (R3) update and grasp its impact on clinical trials and pharmaceutical practices.
  • Practical Insights: Learn how to implement these changes in your work environment with real-world examples and case studies.
  • Flexible Learning: Access the course anytime, anywhere, fitting your busy schedule without compromising on quality learning.
 

Course Highlights:

  • Detailed Breakdown of (R3) Changes: Understand every aspect of the new guidelines, from patient safety to data integrity.
  • Interactive Learning Modules: Engage with interactive content designed to reinforce your learning experience.
  • Certification of Completion: Receive a certificate upon completion, validating your expertise in the ICH-GCP (R3) guidelines.
 

Elevate Your Professional Skills Today! Join a community of forward-thinking professionals adapting to the evolving pharmaceutical landscape. Enroll now and be at the forefront of the ICH-GCP (R3) transition!

COURSE CONTENT

  • Good Clinical Practice
    • Definition
    • Purpose
    • Objective
    • Declaration of Helsinki
    • ICH Member List
  • The Structure of E6(R2) and E6(R3)
  • Emphasis of E6(R2) and E6(R3)
  • The purpose of the revision
  • Principles of ICH E6(R3)
  • IRB/IEC and its composition
  • Investigator
  • Sponsor
  • Data Governance
  • Appendix A. Investigator’s Brochure (IB)
  • Appendix B. Clinical Trial Protocol and Protocol Amendments
  • Appendix C. Essential Records for the Conduct of a Clinical Trial
  • Summary

Revision of Annex II is currently planned to start in 2024. We will update the course as soon as new content gets available. The course is built on the currently available update information (end of 2023). You can see the full timeline here.

You can start your program any time after purchase and define your own pace with our online setup.

VIARES CERTIFICATES

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the program and your exam, you get a personal certificate including:

  • course title
  • contact hours
  • continuing education units (CEU)
  • your overall course score
  • date of completion
  • personal certificate verification code
 

We also show you how to best share your certificate on LinkedIn and other social media platforms.

Obtaining your certificates can provide several potential benefits, including:

  • Professional recognition: A Clinical Research certification demonstrates to employers and colleagues that you have the knowledge and skills necessary to excel in your role as a clinical research professional.
  • Competitive edge: In a competitive job market, having a Clinical Research certification can set you apart from other candidates and increase your chances of being hired or promoted.
  • Career advancement: With a Clinical Research certification, you may be eligible for higher-paying and more advanced roles in the field.
  • Increased knowledge and skills: Pursuing a Clinical Research certification can help you gain a deeper understanding of clinical research methods, regulations, and ethical considerations, which can help you perform your job more effectively.
 

Overall, obtaining a Clinical Research certification can be a worthwhile investment for those who are committed to their career in clinical research and interested in advancing their knowledge and skills.

Hear from our graduates

Joe-Henry

It was a great experience to have gone through the VIARIES Clinical Research Talent Program, which was a breath taken opportunity for me as the course gave me the opportunity to broaden my perspective in regards to the dynamics of

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clinical research. The online learning platform was very informative, well organized, and very inspiring for the future Clinical Research professionals. I particularly enjoyed the online webinars and assignments, which made the content understandable. I strongly recommend it to all folks interested in the field of clinical Research. Finally, many thanks to Dietmar Eglhofer and team for ensuring to provide quality t raining.

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Chiamaka

I am grateful for this opportunity to progress with sound knowledge and skills to be competent in the clinical research field. As an aspiring clinical research professional, this talent program is a step forward to gaining professionalism in clinical

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research alongside my experience on the job. I will ensure others can benefit as I did from VIARES.

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Navigating ICH GCP E6(R3) – Enterprise

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