Summary
In this course, you will get guidance on putting the principles of the ICH GCP E6(R3) guideline into practice.
Among other topics, you will learn how you can apply proportionate, risk-based, and fit-for-purpose approaches, while also considering critical-to-quality factors to support effective risk assessment.
You will gain insight into the latest findings on the new ICH E6 (R3) guideline. The programme features real-world inspection and audit outcomes, along with insights from the GCP unit.
Before joining, you should feel confident in your knowledge of ICH E8 (R1) and ICH E6 (R3). It is therefore expected that you have read these guidelines and familiarised yourself with the ICH GCP E6(R3) training modules, which will be uploaded to your personal Atrium site.
The course will be interactive, built on workshops and small assignments throughout the day to make the learning as practical and concrete as possible.
The panel of lecturers includes representatives from the Danish Medicine Agency, Pharma, and the GCP unit.
Prior to the course, you are welcome to submit any questions or issues from your daily work that you would like us to address during the session.
Keywords
- ICH GCP E6 (R3)
- Quality by design
- Risk management
- Data governance
- Oversight
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Course leader & lecturers
- Susanne Nørskov JørgensenCourse leaderScientific VP Global Clinical Compliance
Novo Nordisk A/S - Birthe Emilie NielsenLecturerDirector, Team Lead
Genmab A/S - Charlotte CalovLecturerHead of the GCP Unit at Odense University Hospital OPEN
OPEN GCP-enheden - Lisbeth BregnhøjLecturerGCP Inspector
Danish Medicines Agency
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Is this course for you?
This course is for you if you work as a sponsor in the pharma industry or in the public health system. It is also relevant for investigators and investigator team members.
The course focuses on the practical impact of the new guideline and is perfect for those working as clinical trial managers, CRAs, monitors, data managers, quality managers, clinical research managers, QA professionals, investigators, or principal investigator delegates.
What you will learn
- Risk assessment and practical implementation
- Critical-to-quality factors and risks
- Practical interpretation of proportionate and fit-for-purpose approaches
- Key changes and ICH objectives for ICH GCP
- Regulatory and Pharma considerations and learnings on implementing ICH E6 (R3)How to address common challenges like unnecessary administrative burden
What your company will get
- An employee who understands the impact ICH E6 (R3) has on investigators and sponsors, and what is needed to implement the changes
- An employee who understands the impact ICH E6 (R3) has on sponsors and service providers, and what is needed to implement the changes
- An employee who understands the perspective of the regulatory authorities and the challenges that may arise, and is, therefore, well prepared to comply with R3.
Course calendar
Day 1
- ICH E6 (R3) Practical Implementation and Latest Findings
- Pharma perspective
- Public sector perspective
- Inspectors' perspective
- Panel discussion
Registration
Registration deadline16 Nov 2026
Lersø Parkallé 101
2100 København Ø
Course information
Prerequisites
Watch and understand available videos on E8 R1 and E6 R3 (1.1, 1.2, 1.3))
Examination
Certificate of participation and passed test
Course leader
Novo Nordisk A/S
Lecturers
Genmab A/S
OPEN GCP-enheden
Danish Medicines Agency
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8 Dec 2026
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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