Summary
The new ICH E6 R3 guideline represents a significant change in clinical trial management.
When implementing this new guideline, you need to reconsider your current processes.
While ICH E6 R3 may present challenges, it's a guideline that the industry should strongly consider adopting in due course. The potential benefits of implementation are likely to outweigh the costs associated with change. It introduces updates that aim to make the guidelines more flexible and adaptable, encouraging a risk-based approach.
We have organized a comprehensive day of learning, where you will gain insights into what it takes to comply with the new guidelines.
Among other topics, you will learn to implement a risk-based approach, which will make your clinical trials more effective and less resource-intensive.
The course will feature a panel of lecturers representing regulatory authorities and the pharmaceutical industry. This format allows for constructive discussions and valuable outcomes.
The day will include workshop sessions, with the intention of making the experience as interactive as possible.
Keywords
- ICH-GCP
- Quality by design
- Risk management
- Data governance
- Feasibility
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Course leader & lecturers
- Lisbeth BregnhøjCourse leaderGCP Inspector
Danish Health and Medicines Authority - Susanne NørskovCourse leaderVP Global Clinical Compliance
Novo Nordisk A/S - William Andy LawtonCourse leaderConsultant/Director
Risk Based Approach Ltd
Is this course for you?
The course is designed for both sponsor and site employees. This is because compliance is a shared responsibility, and it's beneficial for both parties to understand the impact of the guidelines, enabling more effective communication.
What you will learn
- Background to the changes and ICH objectives for ICH GCP
- ICH E6 R3 – Investigator and Site staff impact
- ICH E6 R3 – Sponsor/Vendor impact
- Changes for Investigator, Site staff and sponsor
- Regulatory and Pharma perspectives
What your company will get
- An employee who is familiar with the background to the changes and ICH objectives for ICH GCP
- An employee who knows which impact ICH E6 R3 has on investigator and sponsor, and what is needed to implement the changes
- An employee who knows which impact ICH E6 R3 has on Sponsor/Vendor and what is needed to implement the changes
- An employee who knows the perspective from the regulatory authorities and the pharma industry, and is, therefore, well-prepared to implement R3
Course calendar
Day 1
- ICH E6 R3 – Investigator and Site staff impact
- ICH E6 R3 – Sponsor/Vendor impact
- Investigator and Site staff changes
- Sponsor changes
- Regulatory perspective
- Pharma perspectives
Registration
Registration deadline25 Feb 2025
Lersø Parkallé 101
2100 København Ø
Course information
Prerequisites
Previous knowledge of ICH E6 R2.
Examination
There is no examination for this course.
Course leaders
Danish Health and Medicines Authority
Novo Nordisk A/S
Risk Based Approach Ltd
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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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