Diploma in ICH-GCP managed trials

Get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials

  • 25. Mar 2020
  • 22. Sep 2020

3 days course

Danish

14.750,- DKK ex VAT
(app. 1.983,- EUR ex VAT)

PLEASE NOTE: THIS COURSE IS IN DANISH

Summary

In this course you will get a thorough understanding of ICH-GCP as well as the statutory and practical aspects of executing and monitoring clinical drug trials in Denmark. The course will consist of presentations from authorities and experts in clinical trials complemented by group work and cases.

The starting point of this course is current legislation and guidelines and the different roles and responsibility of monitors and investigators/study nurses. Furthermore, focus will be on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimize your collaboration with your partners.

To achieve a diploma you have to pass the exam of the course, which is held approximately four weeks after the course. The exam must be purchased separately. If you do not complete the exam, you will receive a Certificate of Completion.

Please note: This course replaces Diploma in GCP for project nurses and Diploma in GCP for CRA/monitors.


Keywords

  • Good Clinical Practice ICH-GCP 
  • National legislation
  • Audit and inspection
  • Clinical trial data handling
  • Essential documents
  • Monitoring
  • Safety reporting
  • Study drug handling
  • Site management from site and sponsor’s/CRO’s perspective
  • Collaboration with the industry

Course calendar

Start 25. Mar 2020
25. Mar 2020
26. Mar 2020
27. Mar 2020
Registration deadline 18. Mar 2020
Start 22. Sep 2020
22. Sep 2020
23. Sep 2020
24. Sep 2020
Registration deadline 15. Sep 2020

What you will learn

  1. How to comply with the ICH-GCP and other clinical trial related regulations and guidelines, when conducting and monitoring clinical trials.
  2. What the roles of the involved authorities are – and how to interact both as investigator and as sponsor
  3. How roles and responsibilities are defined for sponsor/CRO and site - and how you can optimize the collaboration between the involved partners
  4. How to collect, monitor and file clinical trial related data throughout the clinical trial
  5. The importance of timely and accurate management of safety data
  6. The importance of correct handling of study medication from packaging to destruction

What your company will get

  1. A GCP professional who knows the essence of current ICH-GCP and how to ensure compliance
  2. A GCP professional who can provide valuable input to other team members regarding ICH-GCP guidelines and relevant regulations
  3. A GCP professional who knows the principles and practical aspects of effective site monitoring
  4. An employee who knows how the importance of good collaboration with relevant stakeholders in clinical trials
  5. An employee who understands the responsibilities and duties of both investigator and sponsor
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.comRead our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

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