Vendor Management and Oversight (basic)

Obtain basic knowledge of industry best practices for clinical vendor management

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No available dates
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On location

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English

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14,925 DKK ex VAT

(app. 2,007 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

Are you compliant with the ICH GCP E6 Guideline R2 revisions on sponsors, Sites, Contract Research Organisations (CROs) and Vendors? And are you confident in your interaction and negotiation with these?

This three day course provides you with basic knowledge about how to comply with ICH GCP E6 Guideline R2.

You also gain insights into ensuring oversight of any trial-related duties and functions carried out on your behalf, including those that are subcontracted to another party by the sponsor’s contracted CRO(s).

Among other things, you learn to foresee potentials misunderstandings and issues. This will enable you to improve relations with vendors and ensure good results.

Please note: We also offer an advanced course in Vendor Management and Oversight.

  



    Keywords

    • Clinical outsourcing management
    • Vendor oversight
    • Risk management
    • Legal contracts
    • Compliance
    • Investigator agreements

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    Course leader & lecturers

    • Tina Harde
      Course leader
      Senior Outsourcing Manager
      Novo Nordisk A/S
    • Joy Bladh
      Lecturer
      Founder & CEO
      Yoj ApS
    • Désirée Hammerstad
      Lecturer
      Director of Outsourcing Management
      Nykode Therapeutics Denmark A/S
    • Gertrud Koefoed Rasmussen
      Lecturer
      VP, Head of Development Operations
      Nykode Therapeutics ASA
    • Camilla Walker
      Lecturer
      Principal Partnership & Vendor Manger
      ALK-Abelló A/S
    • Anders Trojel
      Lecturer
      Business Development Director
      Syneos Health Denmark ApS
    • Jacqui Gatehouse
      Lecturer
      Founder
      GATEHOUSE THIRTEEN
    • Anne Søltoft Andersen
      Lecturer
      Outsourcing Manager
      Novo Nordisk A/S
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    Is this course for you?

    This is a basic course for employees in pharmaceutical, biotech, or medico companies whose responsibilities include working with a CRO. It is an advantage to have some experience in the field. You work as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and want in-depth knowledge of best practices and a competence boost in clinical outsourcing.

    What you will learn

    1. Industry best practices for how to plan, qualify, and select a CRO for a clinical study.
    2. How to negotiate and align expectation with a CRO.
    3. How to carry out oversight and manage a CRO, e.g. how to solve problems.
    4. Understand the overall principles of the legal part of a CRO agreement and site agreement.
    5. Understand ICH GCP E6 Guideline R2 revisions on sponsors, sites, CROs, and vendors.


    What your company will get

    1. An employee who understands the overall principles of the legal part of a CRO agreement and site agreement.
    2. An employee who understands ICH GCP E6 guideline R2 revisions on sponsors, sites, CROs, and vendors.
    3. An employee with insights into implementing the revisions to ICH GCP E6 guideline in your organisation.



    Course information

    Literature

    Optional readings will be available via your personal Atrium log-in. Please familiarise yourself with the readings before starting the course.

    Prerequisites

    You must have some experience with CRO collaboration, interaction and/or negotiation, preferably in relation to outsourcing of clinical trials.

    Course leader

    Tina Harde
    Senior Outsourcing Manager
    Novo Nordisk A/S

    Lecturers

    Joy Bladh
    Founder & CEO
    Yoj ApS
    Désirée Hammerstad
    Director of Outsourcing Management
    Nykode Therapeutics Denmark A/S
    Gertrud Koefoed Rasmussen
    VP, Head of Development Operations
    Nykode Therapeutics ASA
    Camilla Walker
    Principal Partnership & Vendor Manger
    ALK-Abelló A/S
    Anders Trojel
    Business Development Director
    Syneos Health Denmark ApS
    Jacqui Gatehouse
    Founder
    GATEHOUSE THIRTEEN
    Anne Søltoft Andersen
    Outsourcing Manager
    Novo Nordisk A/S

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    Want to know more or need help?

    Contact Client Manager Christina Spangsberg at +45 39 15 09 22

    Send me a message