KU RA M8: 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)

25 Oct 2022
24 Oct 2023

4 days course

English

27,100 DKK ex VAT
(app. 3,644 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.  
 


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. 


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

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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(s) & Lecturer(s)

  • Dorte Bjørn-Larsen
    Course leader
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
  • Christina Balslev Rindshøj
    Course leader
    Senior Director
    Ozack ApS
  • Christina Rindshøj
    Course leader
    Senior Director
    Ozack ApS
  • Stefan Herdinius
    Lecturer
    Executive Regulatory Science Director, Early Respiratory & Immunology
    AstraZeneca AB, Sweden
  • Jeannet Knudsen
    Lecturer
    Lead GCP Auditor
    Novo Nordisk A/S
  • Joris Wilms
    Lecturer
    Chief Operating Officer
    Atrium
  • Tina Zinck
    Lecturer
    Regulatory Affairs Project Director
    Novo Nordisk A/S
  • Kirsten Dahl
    Lecturer
    Clinical Pharmacology Director
    Novo Nordisk A/S
  • Michael Beckert
    Lecturer
    Consultant
    CaRACS Michael Beckert Consulting
  • Tine Aggerholm Bækdal
    Lecturer
    Senior Clinical Pharmacology Advisor
    Novo Nordisk A/S
  • Ida Katrine Lund
    Lecturer
    Global Regulatory Lead
    Novo Nordisk A/S
  • Lars Endahl
    Lecturer
    MSc, PhD, EMM, Statistical Vice President, Biostatistics
    Novo Nordisk A/S
  • Louise Buur
    Lecturer
    Clinical Pharmacology Senior Specialist, Clinical Pharmacology
    H. Lundbeck A/S
  • Jens Heisterberg
    Lecturer
    VP, Regulatory Policy and Intelligence
    Novo Nordisk A/S
  • Eva Bøge
    Lecturer
    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
    Director
    Novo Nordisk A/S
  • Janina Karres
    Lecturer
    Scientific Officer
    EMA - European Medicines Agency
  • Jannik Nielsen
    Lecturer
    Senior Safety Surveillance Adviser, Global Safety
    Novo Nordisk A/S
  • Mette Duelund Simonsen
    Lecturer
    Safety Surveillance Manager
    Novo Nordisk A/S
  • Jeff Craven
    Lecturer
    Principal Medical Writer
    Contura International
  • Martin Strandberg-Larsen
    Lecturer
    Senior Director Market Access
    Veracyte Inc.
  • Alice Bjerregaard Larsen
    Lecturer
    Manager
    LEO Pharma A/S
  • Trine Moulvad
    Lecturer
    VP
    Zealand Pharma A/S
  • Steven Johnson
    Lecturer
    Head of US Regulatory Affairs
    UCB
  • Martin Friedrichsen
    Lecturer
    M.Sc., PhD, Senior Clinical Pharmacology Scientist, Clinical Pharmacology Obesity
    Novo Nordisk A/S
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 25 Oct 2022
Starting 24 Oct 2023
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
25 - 28 Oct
24 Oct 2023 8:30-18:00

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
25 Oct 2023 8:30-16:45

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)
26 Oct 2023 8:30-17:45

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
27 Oct 2023 8:30-16:15

DAY 4

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

Registration

Registration deadline
26 Sep 2023
Register
24 - 27 Oct
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 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)

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

Lecturer(s)

Stefan Herdinius
Executive Regulatory Science Director, Early Respiratory & Immunology
AstraZeneca AB, Sweden
Jeannet Knudsen
Lead GCP Auditor
Novo Nordisk A/S
Joris Wilms
Chief Operating Officer
Atrium
Tina Zinck
Regulatory Affairs Project Director
Novo Nordisk A/S
Kirsten Dahl
Clinical Pharmacology Director
Novo Nordisk A/S
Michael Beckert
Consultant
CaRACS Michael Beckert Consulting
Tine Aggerholm Bækdal
Senior Clinical Pharmacology Advisor
Novo Nordisk A/S
Ida Katrine Lund
Global Regulatory Lead
Novo Nordisk A/S
Lars Endahl
MSc, PhD, EMM, Statistical Vice President, Biostatistics
Novo Nordisk A/S
Louise Buur
Clinical Pharmacology Senior Specialist, Clinical Pharmacology
H. Lundbeck A/S
Jens Heisterberg
VP, Regulatory Policy and Intelligence
Novo Nordisk A/S
Eva Bøge
Regulatory Project Manager
Zealand Pharma A/S
Samuel David Ramsden
Head of Risk Management Office
Boehringer Ingelheim Pharma GmbH & Co. KG
Jane Møll Pedersen
Director
Novo Nordisk A/S
Janina Karres
Scientific Officer
EMA - European Medicines Agency
Jannik Nielsen
Senior Safety Surveillance Adviser, Global Safety
Novo Nordisk A/S
Mette Duelund Simonsen
Safety Surveillance Manager
Novo Nordisk A/S
Jeff Craven
Principal Medical Writer
Contura International
Martin Strandberg-Larsen
Senior Director Market Access
Veracyte Inc.
Alice Bjerregaard Larsen
Manager
LEO Pharma A/S
Trine Moulvad
VP
Zealand Pharma A/S
Steven Johnson
Head of US Regulatory Affairs
UCB
Martin Friedrichsen
M.Sc., PhD, Senior Clinical Pharmacology Scientist, Clinical Pharmacology Obesity
Novo Nordisk A/S

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WANT TO KNOW MORE or need help?

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

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