Summary

This one-day course offers an excellent opportunity to gain more in-depth knowledge on how to practice vendor and sponsor oversight.

The topic will be presented from different angles including perspectives from Pharma, Biotech and contract research organizations (CRO).

Through presentations, workshops, and knowledge sharing, you will gain in-dept knowledge of processes for oversight of full-service CROs, Contract Manufacturing Organizations (CMOs), Functional Outsourcing, and Third-Party Oversight.

At the end of the course, we will host a panel discussion to discuss risk management, exchange experiences, discuss real-life cases and address common challenges.

After this one-day course, you will be able to identify and implement best practices for vendor and third-party oversight.

Keywords

Sponsor oversight
Oversight of full-service CROs
Functional Outsourcing
Third-Party Oversight
Regulations and industry standards on vendor oversight

Save information for later

Course leader & lecturers

Tina Spang Hjorth
Course leader
CEO
ClinOps Consult
Trine Danø Klingberg
Course leader
Head of clinical process management
LEO Pharma A/S

See all

Is this course for you?

This is an advanced course for employees in the pharmaceutical, biotech and medical device industries or CRO companies, whose responsibilities include working with vendors and third-party vendors/ subcontractors. It is a prerequisite to have some experience in the field.

To get the most out of the course, you should have a background as Outsourcing Manager, Clinical Trial Manager, Clinical Trial Supply Manager, Clinical Project Manager or Quality Assurance Manager. You should also be willing to participate in discussions with peers and share best practices and experiences.

What you will learn

Regulations and industry standards on vendor oversight
Common understanding of sponsor and vendor perspectives on vendor oversight
How to carry out vendor oversight and issue handling
Vendor strategy and termination of vendor relationships

What your company will get

An employee with in-depth and up-to-date knowledge of vendor oversight requirements and processes
An employee who understands the sponsor and vendor perspectives on vendor oversight
An employee who can carry out vendor oversight, handle issues as they arise and mitigate potential issues, proactively.
An employee who can develop a vendor oversight strategy and handle vendor terminations effectively.

Course calendar

8 Dec 2026 9:00-16:00

Day 1

Overview of the regulatory framework for oversight
Industry standards and practices
Oversight from a CRO perspective
Third-party oversight: CRO/sponsor perspective
Oversight of IT vendor systems
Risk assessment and consequences of vendor performance outcomes
Oversight of vendors and subcontractor SOPs
Panel discussion

Practical information

Registration

Registration deadline
1 Dec 2026

Atrium
Lersø Parkallé 101
2100 København Ø

Price
7,100 DKK

Register

8 Dec

Please note: The programme structure may be subject to minor adjustments

Course information

Literature

Prior to the course, you’ll get access to mandatory and/or optional readings via your personal Atrium log-in.

Examination

There is no examination for this course.

Want to know more or need help?

Contact Client Manager Christina Spangsberg at +45 39 15 09 22

Send me a message

Go to faq

NEW - Sponsor Oversight