Vendor Management and Oversight (basic)

Obtain knowledge of best industry practices for clinical vendor management (module 1 of 2)
No available dates

On location

English

18,450 DKK ex VAT
(app. 2,481 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 and Vendors? And are you confident in your interaction with CROs?

This course provides you with deep knowledge about how you comply with ICH GCP E6 Guideline R2. You also gain confidence in 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 potential misunderstandings and issues. This will enable you to improve relations with vendors and ensure good results.

  

Key words

  • Clinical outsourcing management
  • Vendor oversight
  • Conflict management
  • Clinical trials
  • Risk management
  • RBQM
  • Negotiation techniques
  • Financial negotiation
  • Legal contracts
  • CSR
  • HCP transparency
  • Compliance
  • Vendor Governance
  • Investigator agreements

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IS THIS COURSE FOR YOU?

This course is solely for employees in pharmaceutical, biotech and medical device companies, whose responsibilities include interacting with a CRO. You have at least 1 year’s experience as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and are looking for a more in-depth understanding 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, negotiate with a CRO and align expectations with your CRO
  2. How to perform CRO oversight
  3. How to manage a CRO, e.g. how to escalate and resolve issues
  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 is be able to implement the revisions to ICH GCP E6 guideline on sponsors, sites, CROs and vendors at your company

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

This course is solely for employees in pharmaceutical, biotech and medical device companies, whose responsibilities include interacting with a CRO. You have at least 1 year’s experience as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and are looking for a more in-depth understanding of best practices and a competence boost in clinical outsourcing.

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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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