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)

  • 10. Apr 2018

4 days course

English

22.950,- DKK ex VAT
(app. 3.086,- 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

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.

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
Available start dates
10. Apr 2018 (Registration deadline 19. Mar 2018)

Registration quick facts for master modules

When you click the “register”-button you will get to the joint Atrium and University of Copenhagen application form. To apply for the course you must fill out the form and send in the relevant documentation. If your application is accepted you will be enrolled both at Atrium and at the University of Copenhagen and your data will be registered at both institutions.

All modules that are mandatory in the Master of Medicines Regulatory Affairs at the University of Copenhagen are paid by invoice sent from the University of Copenhagen. See the University of Copenhagen’s terms and conditions here.

All the master modules can be taken individually. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email  

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