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.

  • 5. Mar 2018
  • 17. Sep 2018

3 days course

Danish

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

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 

Public institutions are offered a 15 % discount on this course. The discount is withdrawn automatically.

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

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

When registering, you can choose the dates that suit you.

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 Carina Schaldemose Hansen, Digital Project Manager at + 45 39 15 09 22, or send her an email at csc@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 on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

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