Clinical Development and Documentation

Gain a comprehensive overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of the Common Technical Document (CTD) (module 8)

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4 - 7 Nov 2025

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On location

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English

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29,184 DKK ex VAT

(app. 3,924 EUR ex VAT)

Summary

This four day course will provide you with an overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of CTD (Modules 2 and 5). The clinical sections are especially important when completing a marketing authorization of a new product or when labeling a product. The sections are also important in helping you meet the needs of patients and also when marketing the product.

The module is relevant for you if you are a regulatory employee who wishes to gain a better understanding of the interrelationships and complexities in clinical development and the current regulatory requirements for developing a new treatment. Our course also provides clinical development staff with the opportunity to gain a better understanding of the relationship between regulatory and clinical strategies as well as the documents that must be prepared prior to regulatory approval.  

Other course participants say:

"The course was well-structured with many really relevant topics and interesting presenters. This course really helps put together the bigger picture when working with clinical development."

Malene Olesen, Senior Regulatory Professional. 


"The course was very comprehensive and covered a multitude of aspects related to clinical development and documentation, both through the use of very knowledgeable presenters and workshops. All the course materials was highly relevant for individuals working with this topic."

Peter Gransgaard, Global Regulatory Affairs Manager, Ferring Pharmaceuticals A/S


    Keywords

    • Global clinical development
    • Global regulatory requirements
    • Clinical study
    • Early clinical development
    • Clinical efficacy and safety trials
    • Target product profile
    • Biomarkers as clinical endpoints
    • Pharmacokinetic, pharmacodynamics and special populations
    • Clinical protocol
    • Interactions and drug/drug interactions
    • Statistics in clinical trials
    • Pediatric development
    • Clinical summaries and clinical overview
    • Benefit-risk assessment tools
    • Post-approval studies
    • Pharmacovigilance
    • Health Technology Assessment (HTA)
    • Interactions with health authorities

    Please note: 

    As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

    Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.


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    Course leader & lecturers

    • Christina Balslev Rindshøj
      Course leader
      VP, Head of Regulatory Affairs
      Zealand Pharma A/S
    • Jane Møll Pedersen
      Course leader
      Director
      Novo Nordisk A/S
    • Hanne Aae Theilgaard
      Lecturer
      Senior Consultant Clinical/Regulatory
      Granzer Regulatory Consulting & Services GmbH
    • Venkata Ravi Geedi
      Lecturer
      Safety Surveillance Specialist
      Novo Nordisk A/S
    • Mette Stie Kallesøe
      Lecturer
      Head of Pharmacovigilance QPPV
      Hansa Biopharma AB
    • Helene Nordahl
      Lecturer
      Senior Director
      Novo Nordisk A/S
    • Jeannet Knudsen
      Lecturer
      Lead GCP Auditor
      Novo Nordisk A/S
    • Joris Wilms
      Lecturer
      Chief Operating Officer
      Atrium
    • Niclas Petri
      Lecturer
      Sr Principal Clinical Pharmacology Specialist
      Novo Nordisk A/S
    • Lars Endahl
      Lecturer
      MSc, PhD, EMM, Statistical Vice President, Biostatistics
      Novo Nordisk A/S
    • Jordi Clarimon
      Lecturer
      Lead Specialist, Clinical Biomarkers
      H. Lundbeck A/S
    • Lillian Sandø
      Lecturer
      Senior Principal Medical Writer
      LEO Pharma A/S
    • Martin Bostrup
      Lecturer
      PhD, Executive Director, Market Access & Medical Affairs, IVD
      Veracyte Inc.
    • Lene Kjær Kirstein
      Lecturer
      Senior Director, Head of Regulatory Science & Policy
      H. LUNDBECK A/S
    • Steven Johnson
      Lecturer
      Head of Global Regulatory Affairs
      UCB, USA
    • Alma Sahl
      Lecturer
      Regulatory Specialist, Global Regulatory Lead
      Novo Nordisk A/S
    • Jens Heisterberg
      Lecturer
      VP, Regulatory Policy and Intelligence
      Novo Nordisk A/S
    • Samuel David Ramsden
      Lecturer
      Head of Risk Management Office
      Boehringer Ingelheim Pharma GmbH & Co. KG
    • Ida Katrine Lund
      Lecturer
      Regulatory Business Development Principal Specialist
      Novo Nordisk A/S
    • Tine Aggerholm Bækdal
      Lecturer
      Senior Clinical Pharmacology Scientific Director
      Novo Nordisk A/S
    • Tina Zinck
      Lecturer
      Regulatory Business Development Director
      Novo Nordisk A/S
    • R. Michael Baldwin
      Lecturer
      Ph.D., Clinical Pharmacology Scientific Director
      Novo Nordisk A/S
    • Dorte Villumsen
      Lecturer
      Senior Principal Professional
      LEO Pharma A/S
    • Josephine Skovgaard Rasmussen
      Lecturer
      Manager, Safety Surveillance Early Development Team II
      Novo Nordisk A/S
    • Marie Aavang Geist
      Lecturer
      Project Director
      Novo Nordisk A/S
    See all

    Watch the video

    Is this course for you?

    This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.

    You must have a minimum of 2 years relevant job experience.

    What you will learn

    1. To create, analyze and evaluate a regulatory strategy plan for the clinical development of a new drug
    2. To understand the principles of clinical development from phase I to IV
    3. To learn how to create competitive product information by optimizing the clinical development plan and supporting the desired labeling

    What your company will get

    1. A regulatory professional who is able to analyze and evaluate a regulatory strategy plan for the clinical development of a new drug
    2. A regulatory affairs professional who has a good understanding of the interrelationships and complexities in clinical Development
    3. A regulatory affairs professional who is able to challenge and ask the right questions with respect to the clinical related documentation

    Course calendar

    Choose your starting date
    Starting 29 Oct 2024
    Starting 4 Nov 2025
    29 Oct 2024 8:15-18:00
    Day 1
    • Global Clinical Development
    • Global regulatory requirements and new trends
    • Clinical study
    • Early clinical development
    • Pharmacokinetics & Pharmacodynamics
    • Special populations
    • Drug interactions
    • Workshop 1 – early development
    30 Oct 2024 8:15-17:30
    Day 2
    • Clinical efficacy and safety trials
    • Patient-Reported Outcomes
    • Statistics in clinical trials
    • Clinical protocol
    • Biomarkers as clinical end points
    • Expedited drug development
    • Advanced therapy medicinal products
    • Workshop 2
    31 Oct 2024 8:15-17:45
    Day 3
    • Benefit-Risk – Assessment tools
    • Clinical summary
    • Clinical overview
    • Target product profile – global focus
    • Product information texts – summary of product characteristics (SMPC)
    • Pharmacovigilance
    • Paediatrics development
    • Post-approval studies
    • Real-World Evidence (RWE)
    • Workshop 3 – late-phase development
    1 Nov 2024 8:15-16:15
    Day 4
    • Integrated clinical study report (ICH E 3)
    • Content and structure of the clinical study report (CSR)
    • HTA
    • Workshop 4 – Drug Safety
    • Interactions with health authorities
    • Information about the exam
    Practical information

    Registration

    Registration deadline
    1 Oct 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Registration deadline expired
    4 Nov 2025 8:15-18:00
    Day 1
    • Global Clinical Development
    • Global regulatory requirements and new trends
    • Clinical study
    • Early clinical development
    • Pharmacokinetics & Pharmacodynamics
    • Special populations
    • Drug interactions
    • Workshop 1 – early development
    5 Nov 2025 8:15-17:30
    Day 2
    • Clinical efficacy and safety trials
    • Patient-Reported Outcomes
    • Statistics in clinical trials
    • Clinical protocol
    • Biomarkers as clinical end points
    • Expedited drug development
    • Advanced therapy medicinal products
    • Workshop 2
    6 Nov 2025 8:15-17:45
    Day 3
    • Benefit-Risk – Assessment tools
    • Clinical summary
    • Clinical overview
    • Target product profile – global focus
    • Product information texts – summary of product characteristics (SMPC)
    • Pharmacovigilance
    • Paediatrics development
    • Post-approval studies
    • Real-World Evidence (RWE)
    • Workshop 3 – late-phase development
    7 Nov 2025 8:15-16:15
    Day 4
    • Integrated clinical study report (ICH E 3)
    • Content and structure of the clinical study report (CSR)
    • HTA
    • Workshop 4 – Drug Safety
    • Interactions with health authorities
    • Information about the exam
    Practical information

    Registration

    Registration deadline
    3 Oct 2025
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    4 - 7 Nov
    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

    To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

    If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.

    Examination

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

    It is a digital exam in the University of Copenhagen’s digital exam system.

    This course is a part of a diploma

    Master of Medicines Regulatory Affairs (MRA)

    Are you a Regulatory Affairs professional and are you concerned with your ongoing learning and development? Consider these courses, offered in together with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA).

    Read more
    Diploma in Regulatory Affairs

    The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

    Read more

    Course leaders

    Christina Balslev Rindshøj
    VP, Head of Regulatory Affairs
    Zealand Pharma A/S
    Jane Møll Pedersen
    Director
    Novo Nordisk A/S

    Lecturers

    Hanne Aae Theilgaard
    Senior Consultant Clinical/Regulatory
    Granzer Regulatory Consulting & Services GmbH
    Venkata Ravi Geedi
    Safety Surveillance Specialist
    Novo Nordisk A/S
    Mette Stie Kallesøe
    Head of Pharmacovigilance QPPV
    Hansa Biopharma AB
    Helene Nordahl
    Senior Director
    Novo Nordisk A/S
    Jeannet Knudsen
    Lead GCP Auditor
    Novo Nordisk A/S
    Joris Wilms
    Chief Operating Officer
    Atrium
    Niclas Petri
    Sr Principal Clinical Pharmacology Specialist
    Novo Nordisk A/S
    Lars Endahl
    MSc, PhD, EMM, Statistical Vice President, Biostatistics
    Novo Nordisk A/S
    Jordi Clarimon
    Lead Specialist, Clinical Biomarkers
    H. Lundbeck A/S
    Lillian Sandø
    Senior Principal Medical Writer
    LEO Pharma A/S
    Martin Bostrup
    PhD, Executive Director, Market Access & Medical Affairs, IVD
    Veracyte Inc.
    Lene Kjær Kirstein
    Senior Director, Head of Regulatory Science & Policy
    H. LUNDBECK A/S
    Steven Johnson
    Head of Global Regulatory Affairs
    UCB, USA
    Alma Sahl
    Regulatory Specialist, Global Regulatory Lead
    Novo Nordisk A/S
    Jens Heisterberg
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
    Samuel David Ramsden
    Head of Risk Management Office
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Ida Katrine Lund
    Regulatory Business Development Principal Specialist
    Novo Nordisk A/S
    Tine Aggerholm Bækdal
    Senior Clinical Pharmacology Scientific Director
    Novo Nordisk A/S
    Tina Zinck
    Regulatory Business Development Director
    Novo Nordisk A/S
    R. Michael Baldwin
    Ph.D., Clinical Pharmacology Scientific Director
    Novo Nordisk A/S
    Dorte Villumsen
    Senior Principal Professional
    LEO Pharma A/S
    Josephine Skovgaard Rasmussen
    Manager, Safety Surveillance Early Development Team II
    Novo Nordisk A/S
    Marie Aavang Geist
    Project Director
    Novo Nordisk A/S

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