Designing quality into clinical trials: ICH E8 (R1)

The impact of updated regulatory guidance on up-front clinical trial planning has become more complex.

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key takeaways

What you will learn

  • How to navigate the complexities of updated regulatory guidance
  • Optimizing clinical trial planning
  • Mitigating and managing potential risks using a quality management approach
About this webinar

Discover all about ICH E8 (R1)

This on-demand webinar provides an overview of ICH E8 (R1) including the proactive planning of clinical studies using Quality by Design (QBD) and Critical to Quality (CTQ) factors assessments.

The aim is to ensure trial operational feasibility, subject safety and quality data for submissions from a multistakeholder lens. This involves input from critical stake holders and proactively defining risks during the protocol design phase and throughout the product lifecycle.

Additionally, understand the mitigation and management of potential risks using a quality management approach. 

Meet our speaker

FAQ

Frequently asked questions

How can I access the webinar?
Simply register and you'll receive a link to watch it immediately. 
Can I pause and resume the webinar?
Yes, you can pause and resume the webinar at your convenience. 
Do I need any special software?
Just a web browser! We’ll send you the link to access.

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