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Hot Topic Webinar: Maintaining oversight in outsourced trial setups

Bridging contractual frameworks and regulatory reality

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Frontpage > Courses > Hot Topic Webinar: Maintaining oversight in outsourced trial setups

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 Lund
    Course leader
    Owner
    HC Legal ApS
  • Ulla Steenstrup
    Lecturer
    Founder
    Steenstrup Legal Life
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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

  1. What sponsors outsource and what they keep in-house
  2. The concept of “ultimate responsibility” under ICH E6
  3. How contracts (CTA, Quality Agreements) align with regulatory expectations, and where they fall short
  4. Where typical gaps and risks arise in outsourced setups
  5. How to strengthen oversight and ensure a coherent setup

What your company will get

An employee who:

  1. Understands the difference between contractual and regulatory responsibility
  2. Can identify misalignment between agreements and the actual setup
  3. Is better equipped to manage vendor oversight
  4. Contributes to reducing regulatory risk

Course information

Examination

There is no examination for this course.

Course leader

Hans-Christian Lund
Owner
HC Legal ApS

Lecturer

Ulla Steenstrup
Founder
Steenstrup Legal Life

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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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