Contracts in Clinical Trials

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

4. Oct 2021
9. Jun 2022

1 day course

Danish

5,300 DKK ex VAT
(app. 713 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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(s) & Lecturers

  • Hans-Christian Lund
    Lecturer
    Head of Legal Department
    ZEALAND PHARMA A/S
  • Susanne Kudsk
    Lecturer
    Senior Legal Adviser/Chefkonsulent
    Aarhus Universitetshospital
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IS THIS COURSE FOR YOU?

Monitors and Clinical Trial Managers, Investigators, Projects Leaders, Project Nurses, Clinical Coordinators and others who work with contracts concerning 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 calendar

Choose your starting date
Starting 4. Oct 2021
Starting 9. Jun 2022
4. Oct 2021 9:00-16:15

DAY 1

  • Background and history of this course
  • General information regarding contracts
- The definition of a contract
- Who can enter into the contract?
- Who is eligible for signing?
- Can you begin without a signature?
  • Which guidelines and legislations regulate the contracts?
  • Danish vs. international
  • What types of contracts exist?
  • Examples of different versions, including clinical trials
  • What do clinical contracts contain?
  • Cases
  • Fictive cases illustrating different issues in the contracts.
- An entrance for the industry – ”Juridisk netværk”
- What is Juridisk netværk, and what does it offer?
- National standard contracts
- What do we look for in the contracts and why?
  • Insurances
- Sponsor coverage
- Hospital insurance
- Pharmaceutical and patient insurance
- How do you cover yourself in the best possible way in the contract?
- How much coverage do you need in the contract concerning assurance?
  • Workshop

    Presentation and discussion of the latest issues and challenges in the daily work. A new healthcare legislation was put into action with effect from May 2018:

- What does this mean when it comes to data access?
- What does it mean for monitoring and research when the law is fully implemented? And how will it affect clinical trials?
- The regions are enforcing new guidelines for overheads, etc.
    Practical information

    Registration

    Registration deadline
    27. Sep 2021
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    9. Jun 2022 9:00-16:00

    DAY 1

    • Background and history of this course
    • General information regarding contracts
    - The definition of a contract
    - Who can enter into the contract?
    - Who is eligible for signing?
    - Can you begin without a signature?
    • Which guidelines and legislations regulate the contracts?
    • Danish vs. international
    • What types of contracts exist?
    • Examples of different versions, including clinical trials
    • What do clinical contracts contain?
    • Cases
    • Fictive cases illustrating different issues in the contracts.
    - An entrance for the industry – ”Juridisk netværk”
    - What is Juridisk netværk, and what does it offer?
    - National standard contracts
    - What do we look for in the contracts and why?
    • Insurances
    - Sponsor coverage
    - Hospital insurance
    - Pharmaceutical and patient insurance
    - How do you cover yourself in the best possible way in the contract?
    - How much coverage do you need in the contract concerning assurance?
    • Workshop

      Presentation and discussion of the latest issues and challenges in the daily work. A new healthcare legislation was put into action with effect from May 2018:

    - What does this mean when it comes to data access?
    - What does it mean for monitoring and research when the law is fully implemented? And how will it affect clinical trials?
    - The regions are enforcing new guidelines for overheads, etc.
      Practical information

      Registration

      Registration deadline
      2. Jun 2022
      Atrium
      Lersø Parkallé 101
      2100 København Ø
      Sometimes things change. This is the expected programme.

      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.

      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(s)

      Lecturers

      Hans-Christian Lund
      Head of Legal Department
      ZEALAND PHARMA A/S
      Susanne Kudsk
      Senior Legal Adviser/Chefkonsulent
      Aarhus Universitetshospital

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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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