Diploma in Vendor Management and Oversight (module 2)

Obtain knowledge of best industry practices for Clinical Vendor Management and Oversight (module 2 of 2)

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  • 25. Apr 2022

3 days course

English

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

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MODULE 2 

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 Diploma course consists of two modules that together provide you with solid knowledge of best industry practices for clinical outsourcing management as well as ensures that you feel confident performing high-quality Oversight of your selected Vendors, your CRO and its subcontractors.

It also provides you with a thorough 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) and Vendor(s).

Among other things, you learn about negotiation techniques, different contractual and pricing models with CROs as well as how to foresee potentials misunderstandings and issues and how to resolve these.

All in all, this will enable you to improve relations with CRO and Vendors and increase the possibility of better results.

 

KEY WORDS

  • Clinical Outsourcing Management
  • Clinical Vendor Management
  • Vendor Oversight
  • Conflict Management
  • Clinical Trials
  • Risk Management
  • Risk Based Quality Management (RBQM)
  • Negotiation Techniques
  • Financial Negotiation
  • Legal Contracts
  • Corporate Social Responsibility (CSR)
  • HCP Transparency
  • Compliance
  • Vendor Governance
  • Investigator Agreements

Course calendar

Start 25. Apr 2022
Registration deadline 12. Apr 2022
25. Apr 20228:30 - 17:00
26. Apr 20228:30 - 17:00
27. Apr 20228:30 - 16:30
Atrium
Lersø Parkallé 101
2100 København Ø

What you will learn


Industry best practices for how to:

  1. Plan, qualify and select a CRO for a clinical study
  2. Negotiate and align expectations with a CRO
  3. Better understand the financial and legal complexities of CRO and Site Agreements
  4. How to perform CRO Oversight
  5. How to manage a CRO, e.g. how to escalate and resolve issues
  6. Understand ICH GCP E6 guideline R2 revisions on sponsors, Sites, CROs and Vendors

What your company will get

An employee who feels confident in:

  1. The outsourcing process including how to select the right CRO for a study
  2. Aligning expectations and scoping the outsourced activities correctly
  3. Following up on CRO deliverables, including how to perform high quality Oversight and risk management
  4. Understanding and using the best negotiation technique as well as the best financial set-up and payment structure
  5. Resolving issues and conflicts with CROs
  6. The contents of the legal contract with CRO and Site
Available start dates
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WANT TO KNOW MORE ABOUT THIS DIPLOMA?

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

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