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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31 Oct 2024

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On location or online

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Danish

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Online 5,900 DKK ex VAT
On location 6,900 DKK ex VAT
50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary


In this one day 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

    • Mikkel Sørensen
      Course leader
      Associate Director, Legal Counsel
      Genmab A/S
    • Danielle Weinreich
      Course leader
      Associate Director, Legal Counsel
      Genmab A/S
    • Iben Dinsen
      Lecturer
      Industry Practices & Environmental Risks Manager, Nordic Countries
      Chubb
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    Is this course for you?

    This course is for anyone who works with contracts in clinical trials, e.g. in a hospital as an investigator, project manager/project nurse, clinical coordinator, monitor or clinical trial manager.

    What you will learn

    1. Understand what a clinical contract between a hospital and a commercial sponsor is and the implications of the contract.
    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?

    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

    31 Oct 2024 9:00-16:00
    Day 1
    • Background and history of this course
    • Review and discussion of relevant legal concepts/issues in clinical contracts

    • Cases
    • Network
      • Insurances
      • Workshop
        Practical information

        Registration

        Registration deadline
        24 Oct 2024
        Atrium
        Lersø Parkallé 101
        2100 København Ø
        Register
        31 Oct
        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.

        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 leaders

        Mikkel Sørensen
        Associate Director, Legal Counsel
        Genmab A/S
        Danielle Weinreich
        Associate Director, Legal Counsel
        Genmab A/S

        Lecturer

        Iben Dinsen
        Industry Practices & Environmental Risks Manager, Nordic Countries
        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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