Clinical Development and Documentation, module 8

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)

Date icon

29 Oct - 1 Nov 2024

Attendance icon

On location

Language icon

English

Price icon
28,472 DKK ex VAT

(app. 3,828 EUR ex VAT)

Summary

Module 8

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.


    Save information for later
    Read more

    Course leader & lecturers

    • Christina Balslev Rindshøj
      Course leader
      VP, Head of Regulatory Affairs
      Zealand Pharma A/S
    • Dorte Bjørn-Larsen
      Course leader
      Global Regulatory Lead, RA Rare Endocrine Disorders
      Novo Nordisk A/S
    See all

    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

    Starting 29 Oct 2024
    29 Oct 2024 8:15-18:00
    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
    30 Oct 2024 8:15-17:30
    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)
    31 Oct 2024 8:15-17:45
    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
    1 Nov 2024 8:15-16:15
    Day 4
    • Pharmacovigilance
    • HTA
    • Workshop 6 – Drug safety
    • Interactions with health authorities
    Practical information

    Registration

    Registration deadline
    17 Sep 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    29 Oct - 1 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
    Dorte Bjørn-Larsen
    Global Regulatory Lead, RA Rare Endocrine Disorders
    Novo Nordisk A/S

    You may also be interested in these courses

    Want to know more or need help?

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

    Send me a message