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Navigating ICH GCP (Good Clinical Practice) E6 (R3): What You Need to Know Training Course

This brand new course on the recently published and long-awaited ICH GCP E6 (R3) is designed to help participants stay compliant and implement the new guideline effectively.

20 May 2025
+ 12 September 2025, 15 January 2026 »

from £649

Need help?  Enrol/reserve

Course overview

The ICH GCP E6 (R3) guideline represents a significant evolution in the conduct of clinical trials, emphasising flexibility, risk-based approaches, and the integration of innovative technologies. This one-day training course is designed to provide clinical research professionals with a comprehensive understanding of the updated guidelines, ensuring compliance and enhancing the quality of clinical trials.

Through a combination of expert-led lectures and group discussions, you will engage in practical exercises to reinforce key concepts and application to real-world scenarios. This training is ideal for all clinical research professionals committed to maintaining GCP compliance in their work. By the end of the course, you will be well-prepared to navigate the regulatory requirements and effective implementation of the new GCP requirements.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

  • Understand the key updates and principles of ICH GCP E6 (R3)
  • Recognise the roles and responsibilities of stakeholders, including sponsors, investigators, and ethics committees
  • Implement risk-based approaches in clinical trials
  • Prepare for regulatory inspections and ensure ongoing compliance
  • Stay compliant and ahead of GCP regulatory changes
  • Gain practical strategies to implement ICH GCP (R3)
  • Network and share insights with peers

Who should attend?

This session will be beneficial to anybody who is involved in clinical research. It is applicable to pharma, clinical research organisations (CROs), service providers and investigator sites.

This course is ideal for:

  • Clinical Research Associates (CRAs)
  • Clinical trial managers and project managers
  • Regulatory affairs professionals
  • Quality assurance personnel
  • Investigators and site staff
  • Data managers
  • Anyone involved in the planning, execution, or oversight of clinical trials

Enrol/reserve

This course will cover:

Introduction to ICH GCP E6 (R3)

Core principles of ICH GCP E6 (R3)

Stakeholder responsibilities

  • Roles of Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
  • Investigator obligations
  • Sponsor responsibilities
  • Service providers   

Risk-based approaches

Data governance and integrity

Data and records

Investigator brochures

Protocols

Essential records

Preparing for regulatory inspections

Implementation considerations

Enrol/reserve

Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent QA and training consultant and was director of the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years experience of managing GCP inspections in the pharmaceutical industry and has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a clinical research manager, audit director and head of a training department. She is an international expert on GCP and clinical trial requirements and was chair of the Institute of Clinical Research GCP Forum for six years. Laura writes regularly on clinical research regulatory requirements and has written a chapter in International Pharmaceutical Product Registration and several articles on the EU Clinical Trial Regulation, and ICH GCP R2 and R3.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

20 May 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15665

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 15 Apr

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Not ready to book yet?

for 7 days, no obligation

12 September 2025

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 15666

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 08 Aug

View basket 

 
Not ready to book yet?

for 7 days, no obligation

15 January 2026

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 15667

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 11 Dec

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Run Navigating ICH GCP E6 (R3): What You Need to Know Live online for your team

Pricing from:

  • GBP 500
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy