Summary
This one-day course offers an excellent opportunity to gain more in- dept 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 where we plan on inviting representatives from the Danish Medicine Agency. Among other topics, we will discuss risk management, and you will have the opportunity to 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
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Course leader & lecturers
- Tina HardeCourse leaderSenior Outsourcing Manager
Novo Nordisk A/S - Amalie Engemand HenriksenLecturerDirector, Global Clinical Drug Supply
Genmab A/S - Gertrud Koefoed RasmussenLecturerVP, Head of Development Operations
Nykode Therapeutics ASA - Sara Daugaard PopikLecturerChief Operating Officer
Sanos A/S
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
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
Registration
Registration deadline16 Sep 2025
Lersø Parkallé 101
2100 København Ø
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.
Course leader
Novo Nordisk A/S
Lecturers
Genmab A/S
Nykode Therapeutics ASA
Sanos A/S
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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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