Diploma in Vendor Management and oversight (module 1)

Obtain knowledge of best industry practices for clinical vendor management (module 1 of 2)

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  • 14. Jun 2021

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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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 Diploma consists of two modules that together provide 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 potentials 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

Course calendar

Start 14. Jun 2021
Registration deadline 14. Jun 2021
14. Jun 20218:30 - 17:15
15. Jun 20218:00 - 17:00
16. Jun 20218:00 - 16:15
Atrium
Lersø Parkallé 101
2100 København Ø

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
Available start dates
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Want to know more about this course?

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

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