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

4 days course

English

25.795,- DKK ex VAT
(app. 3.468,- 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.

Course fee is DKK 23,250 + exam fee DKK 2,625 = DKK 25,875 in total. 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.


Terms and conditions for signing up to and cancelling courses offered in collaboration between Atrium and the University of Copenhagen

  • These conditions apply to courses in Regulatory Affairs held in collaboration between Atrium and the University of Copenhagen.
  • These conditions apply as long as the campaign offering 2 participants for the price of 1 is valid, i.e. through May 31, 2020.
  • Enrolment to the University of Copenhagen via the course application form
  • The promotional offer 2 for 1 is obtained when two people from the same company register individually for the course and send an email to master@sund.ku.dk stating who you are participating with.
  • If one of the two participants cancels course participation, the full participation fee is still due, since the discount depends on two persons having signed up.
  • If one of the two participants cancels course participation, it is not possible for another employee from the company to take that place on the course within the discount scheme.
  • It is a condition that the debtor on the two payments is the same.
  • Master students' discount of DKK 2,000 waives if the promotional ”2 for 1” offer is used.

Course calendar

Start 11. Oct 2021
Registration deadline 13. Sep 2021
11. Oct 20219:00 - 16:00
12. Oct 20219:00 - 16:00
13. Oct 20219:00 - 16:00
14. Oct 20219:00 - 16:00

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
11. Oct 2021
Registration deadline 13. Sep 2021

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

Send an email

 

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