Summary
What does it take to be inspection-ready in today’s clinical landscape, especially when clinical trials are outsourced?
In this free webinar, Hans-Christian Lund, owner of HC Legal, is joined by Charlotte Tværmose, Head of QA at Gubra, to explain what inspection readiness looks like in practice.
Together, they will share hands-on insights into how organisations can move from a theoretical state of readiness to being truly prepared, especially when outsourcing clinical trials.
Participants will gain insight into typical gaps, regulatory expectations, and concrete actions to strengthen readiness.
Keywords
- Inspection readiness
- ICH GCP (R3)
- Sponsor oversight
- Clinical trial outsourcing
- GxP compliance
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Course leader & lecturers
- Hans-Christian LundCourse leaderOwner
HC Legal ApS
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Is this course for you?
This course is relevant for professionals in biotech and pharmaceutical companies working with:
- Clinical trials
- Quality assurance (QA)
- Regulatory affairs
- Vendor management and oversight
It is particularly relevant for organisations that outsource clinical trial activities. Professionals working at public clinical sites will also find this webinar valuable.
What you will learn
- What “inspection readiness” means in practice from a sponsor perspective
- How ICH GCP(R3) may impact expectations and ways of working
- Where organisations typically face challenges in outsourced setups
- How to identify gaps before they are exposed during inspections
- Practical steps to strengthen oversight and readiness
What your company will get
An employee who:
- Has a clearer understanding of regulatory expectations
- Can identify weaknesses in current setups
- Is better equipped to strengthen sponsor oversight
- Contributes to a more robust and inspection-ready organisation
Course calendar
Day 1
- Introduction and framing of inspection readiness
- What does “being ready” mean?
- Typical gaps and challenges in outsourced setups
- Practical approaches to strengthening readiness
- Summary and key takeaways
- Q&A
Course information
Examination
There is no examination for this course.
Course leader
HC Legal ApS
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18 Aug 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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