Summary
When sponsors outsource clinical trials, tasks can be delegated, but responsibility remains.
In this webinar, Hans-Christian Lund, owner of HC Legal, and Mikkel Sørensen, Associate Director at Genmab, explore one of the most overlooked risk areas in clinical development: the interplay among contracts, regulatory requirements, and how trials are conducted.
You will gain a practical perspective on how to ensure alignment between contractual frameworks and regulatory expectations, and what happens when that alignment is missing.
You will also gain insight into common pitfalls, including unclear responsibility, misalignment between agreements, and lack of transparency across vendor chains.
Keywords
- Sponsor oversight
- ICH E6 (R3)
- Clinical trial agreements
- Vendor management
- Regulatory compliance
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Course leader & lecturers
- Hans-Christian LundCourse leaderOwner
HC Legal ApS - Mikkel SørensenLecturerAssociate Director, Legal Counsel
Genmab A/S
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Is this course for you?
This course is relevant for professionals in the biotech and pharmaceutical industries working with:
- Clinical trials
- Quality assurance (QA)
- Regulatory affairs
- Vendor management and oversight
It is particularly relevant for organisations that outsource clinical trial activities.
Those working at clinical sites will also benefit from this webinar.
What you will learn
- What sponsors outsource and what they keep in-house
- The concept of “ultimate responsibility” under ICH E6
- How contracts (CTA, Quality Agreements) align with regulatory expectations, and where they fall short
- Where typical gaps and risks arise in outsourced setups
- How to strengthen oversight and ensure a coherent setup
What your company will get
An employee who:
- Understands the difference between contractual and regulatory responsibility
- Can identify misalignment between agreements and the actual setup
- Is better equipped to manage vendor oversight
- Contributes to reducing regulatory risk
Course calendar
Day 1
Introduction and framing: what is outsourced?
Sponsor's responsibility under ICH E6
Contracts versus regulatory expectations
The two worlds of contractual versus regulatory reality
Where challenges arise with CROs and subcontractors
Key reflections and takeaways
Q&A
Course information
Examination
There is no examination for this course.
Course leader
HC Legal ApS
Lecturer
Genmab A/S
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8 Dec 2026
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Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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