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

Date icon

11 - 13 Sep 2024

or

9 - 11 Dec 2024

Attendance icon

On location

Language icon

Danish

Price icon
20,200 DKK ex VAT

(app. 2,716 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

At this course, you 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 consists 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 responsibilities of monitors and investigators/study nurses.

Furthermore, focus is on site management from the site and sponsor’s/CRO’s point of view, giving you a unique opportunity to optimise your collaboration with your partners.

To achieve a Diploma you must pass the exam, which is held approximately four weeks after the course. The exam must be purchased separately . If you do not take the exam, you will receive a certificate of completion.


This is what course participants say

"It was a very well-planned course with good lectures and course leaders who had a great overview and managed the course very well."

Pernille Videbæk Pedersen, GCP-Coordinator, Aarhus University.


"It was a very well-structured course, which academically had a high level." 

Pernille Skovby, National Coordinator at DanPedMed.


    Keywords

    • Good Clinical Practice ICH-GCP
    • National legislation
    • Audit and inspection
    • Essential documents
    • Safety reporting
    • Site management from site and sponsor’s/CRO’s perspective

    You deserve to be celebrated!

    We are excited every time one of our course participants completes a diploma: You've made a significant investment in yourself, and that deserves recognition. That's why we host a diploma ceremony twice a year. You can find available dates and register here. At the event, you'll receive your diploma, and we'll provide some refreshments. Feel free to bring your family along.

    Should you prefer to receive you diploma via mail, this is, of course, also possible.


    Save information for later
    Read more

    Course leader & lecturers

    • Lene Palfelt
      Course leader
      Competency Development Specialist
      Novo Nordisk A/S
    • Lærke Brygger Madsen
      Course leader
      GCP-koordinator, cand.scient.med
      GCP-enheden ved Aalborg universitetshospital
    • Jeanette Blom
      Lecturer
      GCP Koordinator
      GCP-enheden
    • Pernille Ask Aabo
      Lecturer
      GCP Koordinator; M.Sc.Pharm
      GCP-enheden
    • Michala Bohn Wirsén
      Lecturer
      Chefkonsulent, jurist
      Region Hovedstaden
    • Stine Glasdam
      Lecturer
      Data Management Specialist
      Novo Nordisk A/S
    • Heidi Filtenborg Madsen
      Lecturer
      Senior Specialist, QPPV Office
      Lundbeck A/S
    • Malene Hansen
      Lecturer
      RBQM Specialist
      Novo Nordisk A/S
    • Lene Eskildsen
      Lecturer
      Head of Quality Assurance
      Vicore Pharma AB
    See all

    Is this course for you?

    This diploma course is a basic training aimed at new monitors, project nurses, and investigators. It is an advantage to have some experience in the field.

    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

    Course calendar

    Choose your starting date
    Starting 11 Sep 2024
    Starting 9 Dec 2024
    11 Sep 2024 10:00-17:25
    Day 1
    • ICH-GCP
      • Investigator’s role and responsibilities
      • Investigator’s oversight/supervision
      • Sponsor’s role and responsibilities
      • Sponsor’s oversight
      • Danish legislation
    • Introduction to clinical drug development
    • Involved authorities:
      • Danish Medicines Agency (DKMA)
        • DKMA’s role
        • Danish legislation on this topic
        • Approval procedure
      • The independent ethical committee system
        • Overview of the committee system
        • Approval process
        • Subject information and informed consent
    • Group work
      12 Sep 2024 8:30-17:40
      Day 2
      • Clinical trial data (collection)
        • Trial data
        • CRF
        • Source data
      • General Data Protection Regulation (GDPR)
        • Terminology
        • Distribution of responsibilities (Data owner / Data processor)
      • Essential documents
        • Trial Master File
        • Investigator’s Brochure
        • Protocol
        • Subject information and informed consent
        • ID- and Screenings Log
        • Delegation log
        • Contracts
      • Safety reporting
        • Definitions
        • Standards for reporting
        • Areas of responsibilities
      • Group work
      • Handling of investigational medicinal product (IMP) in clinical trials
        • Distribution of responsibilities – site vs. monitor
        • Accountability - Site control at receiving IMP
        13 Sep 2024 8:30-15:25
        Day 3
        • Monitoring and collaboration with sites
          • Monitoring in general
          • Pre-study Visit and Initiation Visit
          • Monitoring Visits
          • Close out Visit
        • Risk based quality management
        • Site audits & Inspections
          • Requirement for quality systems
          • Audit and Inspection types
          • Findings


          Practical information

          Related exams

          10 Oct 2024 10:00-13:00
          Go to exam page

          Registration

          Registration deadline
          4 Sep 2024
          Atrium
          Lersø Parkallé 101
          2100 København Ø
          Sold out
          9 Dec 2024 9:00-16:00
          Day 1
          • ICH-GCP
            • Investigator’s role and responsibilities
            • Investigator’s oversight/supervision
            • Sponsor’s role and responsibilities
            • Sponsor’s oversight
            • Danish legislation
          • Introduction to clinical drug development
          • Involved authorities:
            • Danish Medicines Agency (DKMA)
              • DKMA’s role
              • Danish legislation on this topic
              • Approval procedure
            • The independent ethical committee system
              • Overview of the committee system
              • Approval process
              • Subject information and informed consent
          • Group work
            10 Dec 2024 9:00-16:00
            Day 2
            • Clinical trial data (collection)
              • Trial data
              • CRF
              • Source data
            • General Data Protection Regulation (GDPR)
              • Terminology
              • Distribution of responsibilities (Data owner / Data processor)
            • Essential documents
              • Trial Master File
              • Investigator’s Brochure
              • Protocol
              • Subject information and informed consent
              • ID- and Screenings Log
              • Delegation log
              • Contracts
            • Safety reporting
              • Definitions
              • Standards for reporting
              • Areas of responsibilities
            • Group work
            • Handling of investigational medicinal product (IMP) in clinical trials
              • Distribution of responsibilities – site vs. monitor
              • Accountability - Site control at receiving IMP
              11 Dec 2024 9:00-16:00
              Day 3
              • Monitoring and collaboration with sites
                • Monitoring in general
                • Pre-study Visit and Initiation Visit
                • Monitoring Visits
                • Close out Visit
              • Risk based quality management
              • Site audits & Inspections
                • Requirement for quality systems
                • Audit and Inspection types
                • Findings


                Practical information

                Related exams

                10 Jan 2025 10:00-13:00
                Go to exam page

                Registration

                Registration deadline
                24 Nov 2024
                Atrium
                Lersø Parkallé 101
                2100 København Ø
                Register
                9 - 11 Dec
                Sometimes things change. This is the expected programme.

                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.

                The mandatory readings are also part of the examination syllabus.

                Prerequisites

                Experience with contractual relations in clinical trials is an advantage, but not a requirement.

                Examination

                The exam is held online, usually 4-6 weeks after the course.

                You will receive a link with exam questions via your personal Atrium log-in.

                In order to participate in the exam, you must have attended the course.

                Course leaders

                Lene Palfelt
                Competency Development Specialist
                Novo Nordisk A/S
                Lærke Brygger Madsen
                GCP-koordinator, cand.scient.med
                GCP-enheden ved Aalborg universitetshospital

                Lecturers

                Jeanette Blom
                GCP Koordinator
                GCP-enheden
                Pernille Ask Aabo
                GCP Koordinator; M.Sc.Pharm
                GCP-enheden
                Michala Bohn Wirsén
                Chefkonsulent, jurist
                Region Hovedstaden
                Stine Glasdam
                Data Management Specialist
                Novo Nordisk A/S
                Heidi Filtenborg Madsen
                Senior Specialist, QPPV Office
                Lundbeck A/S
                Malene Hansen
                RBQM Specialist
                Novo Nordisk A/S
                Lene Eskildsen
                Head of Quality Assurance
                Vicore Pharma AB

                You may also be interested in these courses

                Want to know more or need help?

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

                Send me a message