Summary
In this course we will cover and discuss the – often very complex – legal rules and principles for contracts in clinical trials as well as the requirements as a result of these contracts. We will focus on substantial sections in contracts, including responsibility, ownership of inventions and data, rights of publication and insurance.
We will discuss how you as an investigator, project manager/nurse, clinical coordinator, monitor, clinical trial manager or similar, prepare, negotiate and indemnify a contract in the best way possible, as well as how you make sure the consequent requirements are met.
Keywords
- General information about contracts
- Guidelines and laws that regulate contracts
- Types of contracts
- Rights and duties for sponsor and investigator
- Ownership of data
- Insurance
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Course leader & lecturers
- Hans-Christian LundCourse leaderHead of Legal Department
ZEALAND PHARMA A/S - Mikkel SørensenLecturerAssociate Director, Legal Counsel
Genmab A/S - Iben DinsenLecturerIndustry Practices & Environmental Risks Manager, Nordic Countries
Chubb
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Is this course for you?
The course is especially for monitors, clinical trial managers, investigators, project leaders or project nurses, who work with other contracts for participation in clinical trials.
What you will learn
- What a contract is and the meaning of it
- The substantial requirements, considerations and interests behind clinical contracts
- The latest knowledge in the field of clinical contracts
- Practical and useful information and good advice applicable in your work forward
- Which insurances are necessary, and why?
- Requirements concerning clinical trials, especially in new legislation
What your company will get
- An employee who understands the important process of collaboration between clinical sites and sponsors
- An employee who will bring valuable input and insights to the table in connection to clinical contracts
- An employee who can assure an optimal and fast process when it comes to entering clinical contracts
- An employee who understands which requirements should be met when conducting the contracts
Course calendar
Day 1
- Background and history of this course
- General information regarding contracts
- Cases
- Fictive cases illustrating different issues in the contracts.
- Insurances
- Workshop
Registration
Registration deadline9 May 2024
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The course focuses on helping you solve practical challenges in your everyday tasks. Therefore, before the start of the course, you will be asked to submit issues that you experience in everyday life and wish to be discussed at the course.
Prerequisites
Experience with contractual relations in clinical trials is an advantage, but not a requirement.
Examination
There is no examination for this course.
Course leader
ZEALAND PHARMA A/S
Lecturers
Genmab A/S
Chubb
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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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