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)

11. Oct 2021
25. Oct 2022

4 days course

English

26,440 DKK ex VAT
(app. 3,555 EUR ex VAT)

Module 8

Summary

This module 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.  
  

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

Hi! Do you need help choosing the right course?

We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com

    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.

    Read more

    Course leader(s) & Lecturers

    • Christina Balslev Rindshøj
      Course leader
      Senior Director
      Ozack ApS
    • Dorte Bjørn-Larsen
      Course leader
      Senior Regulatory Affairs Manager
      Novo Nordisk A/S
    • Stefan Herdinius
      Lecturer
      Executive Regulatory Science Director, Early Respiratory & Immunology
      AstraZeneca AB, Sweden
    • Jeannet Ettrup Rittig Knudsen
      Lecturer
      Lead GCP Auditor
      Novo Nordisk A/S
    • Joris Wilms
      Lecturer
      Chief Operating Officer
      Atrium
    • Tina Zinck
      Lecturer
      Senior Global Regulatory Lead
      Novo Nordisk A/S
    • Michael Beckert
      Lecturer
      Consultant
      Atrium
    • Lars Endahl
      Lecturer
      MSc, PhD, EMM, Statistical Vice President, Biostatistics
      Novo Nordisk A/S
    • Jeff Craven
      Lecturer
      Principal Medical Writer
      Contura International
    • Jens Heisterberg
      Lecturer
      VP, Regulatory Policy and Intelligence
      Novo Nordisk A/S
    • Eva Bøge
      Lecturer
      Senior Regulatory Project Manager
      Zealand Pharma A/S
    • Samuel David Ramsden
      Lecturer
      Head of Risk Management Office
      Boehringer Ingelheim Pharma GmbH & Co. KG
    • Jane Møll Pedersen
      Lecturer
      Senior Director, Regulatory Affairs
      Novo Nordisk A/S
    • Mette Duelund Simonsen
      Lecturer
      Safety Surveillance Manager
      Novo Nordisk A/S
    • Alice Bjerregaard Larsen
      Lecturer
      Manager
      LEO Pharma A/S
    • Trine Moulvad
      Lecturer
      Vice president, Regulatory Affairs & Pharmacovigilance
      Zealand Pharma A/S
    • Steven Johnson
      Lecturer
      Vice President, Regulatory Affairs
      Medpace, Inc.
    See all

    IS THIS COURSE FOR YOU?

    Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills.

    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 11. Oct 2021
    Starting 25. Oct 2022
    11. Oct 2021 8:00-18:00

    DAY 1

    • Global clinical development
    • Global regulatory requirements and new trends
    • Clinical study
    • Workshop 1 – GCP in clinical development
    • Early clinical development
    • Clinical efficacy and safety trials
    • Pharmacokinetics & pharmacodynamics
    • Workshop 2 - Clinical protocol
    12. Oct 2021 8:00-18:00

    DAY 2

    • Special populations
    • Interactions and drug/drug interactions
    • Statistics in clinical trials
    • Workshop 3
    • Biomarkers as clinical endpoints
    • Target product profile – Global focus
    • Product information texts – summary of product characteristics (SMPC)
    13. Oct 2021 8:00-17:45

    DAY 3

    • Paediatrics development
    • Benefit-risk – assessment tools
    • Workshop 4 – benefit/Risk case
    • Clinical summaries
    • Clinical overview
    • Single pivotal trial approvals
    • Post-approval studies
    • Integrated clinical study report (ICH e 3)
    • Content and structure of the clinical study report (CSR)
    • Workshop 5 – late phase development
    14. Oct 2021 8:00-16:15

    DAY 4

    • Pharmacovigilance
    • HTA
    • Workshop 6 – Drug safety
    • Interactions with health authorities
    Practical information

    Registration

    Registration deadline
    13. Sep 2021
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    25. Oct 2022 8:00-18:00

    DAY 1

    • Global clinical development
    • Global regulatory requirements and new trends
    • Clinical study
    • Workshop 1 – GCP in clinical development
    • Early clinical development
    • Clinical efficacy and safety trials
    • Pharmacokinetics & pharmacodynamics
    • Workshop 2 - Clinical protocol
    26. Oct 2022 8:00-18:00

    DAY 2

    • Special populations
    • Interactions and drug/drug interactions
    • Statistics in clinical trials
    • Workshop 3
    • Biomarkers as clinical endpoints
    • Target product profile – Global focus
    • Product information texts – summary of product characteristics (SMPC)
    27. Oct 2022 8:00-17:45

    DAY 3

    • Paediatrics development
    • Benefit-risk – assessment tools
    • Workshop 4 – benefit/Risk case
    • Clinical summaries
    • Clinical overview
    • Single pivotal trial approvals
    • Post-approval studies
    • Integrated clinical study report (ICH e 3)
    • Content and structure of the clinical study report (CSR)
    • Workshop 5 – late phase development
    28. Oct 2022 8:00-16:15

    DAY 4

    • Pharmacovigilance
    • HTA
    • Workshop 6 – Drug safety
    • Interactions with health authorities
    Practical information

    Registration

    Registration deadline
    27. Sep 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    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. You can therefore take the exam in your own country.

    Please let us know if this is relevant for you as we can conduct exams at embassies, universities and so on worldwide.

    This course is a part of this programme

    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 development with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA)

    Read more
    Regulatory Affairs Diploma

    The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

    Read more

    Course leader(s)

    Christina Balslev Rindshøj
    Senior Director
    Ozack ApS
    Dorte Bjørn-Larsen
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S

    Lecturers

    Stefan Herdinius
    Executive Regulatory Science Director, Early Respiratory & Immunology
    AstraZeneca AB, Sweden
    Jeannet Ettrup Rittig Knudsen
    Lead GCP Auditor
    Novo Nordisk A/S
    Joris Wilms
    Chief Operating Officer
    Atrium
    Tina Zinck
    Senior Global Regulatory Lead
    Novo Nordisk A/S
    Michael Beckert
    Consultant
    Atrium
    Lars Endahl
    MSc, PhD, EMM, Statistical Vice President, Biostatistics
    Novo Nordisk A/S
    Jeff Craven
    Principal Medical Writer
    Contura International
    Jens Heisterberg
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
    Eva Bøge
    Senior Regulatory Project Manager
    Zealand Pharma A/S
    Samuel David Ramsden
    Head of Risk Management Office
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Jane Møll Pedersen
    Senior Director, Regulatory Affairs
    Novo Nordisk A/S
    Mette Duelund Simonsen
    Safety Surveillance Manager
    Novo Nordisk A/S
    Alice Bjerregaard Larsen
    Manager
    LEO Pharma A/S
    Trine Moulvad
    Vice president, Regulatory Affairs & Pharmacovigilance
    Zealand Pharma A/S
    Steven Johnson
    Vice President, Regulatory Affairs
    Medpace, Inc.

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    WANT TO KNOW MORE or need help?

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

    Send me a message