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Clinical Trials Quality & Inspection Updates

  • 10 - 12 June 2024
  • Online Live Stream | 14:00 CEST – 17:30 CEST
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Clinical Trials Quality & Inspection Updates

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online live

Training features

Fully online

All sessions of this unique course online

Live interaction

Live interaction options between the delegates and trainer

On any device

Available via mobile, tablet or laptop

Course description

This practical course provides an in-depth understanding of current and planned GCP requirements and their practical implications as well as insights into the current GCP inspection focus and hot topics. 
The course will discuss the forthcoming changes in ICH GCP (E6 Revision 3) and their impact as well as the implementation of ICH E8 R1 covering Quality by Design principles.
The course will bring clarifications on risk-based approaches used in clinical trials, and how to implement acceptable risk management tools. We will also touch base on the changes required following the implementation of the EMA Guideline on computerized systems and electronic data in clinical trials.
We will discuss how to fulfil sponsor oversight expectation and you will learn how to achieve proven inspection readiness. Samples of inspection observations will also be shared.

meet the training leader
Jeannette Dixon | Fleming
Linkedin
Jeannette Dixon
Independent GCP QA Consultancy
United Kingdom
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Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Clinical Trials Quality and Inspection Updates online live training organized by Fleming_Agenda Cover
Clinical Trials Quality and Inspection Updates online live training organized by Fleming_Agenda Cover
Clinical Trials Quality and Inspection Updates online live training organized by Fleming_Agenda Cover
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Topics

  • Updates on GCP developments and practical implications
    • Reminder of main requirements of the current ICH E6 (R2)
    • Planned ICH E6 (R3) – assessment of potential changes, key principles and critical considerations for sponsors, CROs and sites
    • GCP Quiz
    • Implementation of ICH E8 (R1) – Quality by Design principles
    • Computer Systems and electronic data in clinical trials – EMA expectations
    • European Clinical Trial Regulation – any news?

  • Clinical Trial risk-based approach - implementation and best practices
    • Quality risk management principles and tools for pragmatic use

  • GCP inspections and inspection preparation
    • Critical considerations for inspection readiness
    • Inspection observations

  • Sponsor oversight – expectations and execution
    • What does good oversight look like and how to achieve it

Benefits of attending

  • Understand practical implementations of current and future developments in GCP, including ICH E6 R3 and the newly implemented EMA Guideline on computerized systems and electronic data in clinical trials
  • Update yourself with Clinical Trial Risk Management tools and best practices
  • Get critical insides regarding the implementation and management of Sponsor oversight
  • Explore GCP inspection readiness tools and learn about inspection outcomes

Testimonials

Very informative, well-paced content. Practical and applicable. Also nice that it is a small group and run over 3 half- days.
Martinette NelClinical QA & Senior Portfolio Officer, GARDP foundation
The course was interesting and teaching. Jeannette answers were complete and relevant and attached to the everyday issues we’re facing in our work.
Carmel DafnaClinical QA, ADRES
Excellent overview of key topics for quality and inspections of clinical trials.
Daniel SaganClinical Trials Manager, Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

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