Contracts and insurance in clinical trials

Are you familiar with the legal rules and principles in contracts and the consequent requirements in clinical trials?

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6,550 DKK ex VAT

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50% DISCOUNT FOR PUBLIC INSTITUTIONS
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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 Lund
    Course leader
    Head of Legal Department
    ZEALAND PHARMA A/S
  • Lone Hertz
    Lecturer
    Partner
    Hertz & Co. Forsikringsrådgivere I/S
  • Mikkel Sørensen
    Lecturer
    Associate Director, Legal Counsel
    Genmab A/S
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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

  1. What a contract is and the meaning of it
  2. The substantial requirements, considerations and interests behind clinical contracts
  3. The latest knowledge in the field of clinical contracts
  4. Practical and useful information and good advice applicable in your work forward
  5. Which insurances are necessary, and why?
  6. Requirements concerning clinical trials, especially in new legislation

What your company will get

  1. An employee who understands the important process of collaboration between clinical sites and sponsors
  2. An employee who will bring valuable input and insights to the table in connection to clinical contracts
  3. An employee who can assure an optimal and fast process when it comes to entering clinical contracts
  4. An employee who understands which requirements should be met when conducting the contracts

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

Hans-Christian Lund
Head of Legal Department
ZEALAND PHARMA A/S

Lecturers

Hans-Christian Lund
Head of Legal Department
ZEALAND PHARMA A/S
Lone Hertz
Partner
Hertz & Co. Forsikringsrådgivere I/S
Mikkel Sørensen
Associate Director, Legal Counsel
Genmab 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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