Non-clinical Development and Documentation

Get an overview of the requirements and critical issues of non-clinical studies

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  • 15. Sep 2020

3 days course

English

17.650,- DKK ex VAT
(app. 2.373,- EUR ex VAT)

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Module 7

Summary

This module will provide you with a comprehensive overview of the requirements and critical issues of non-clinical studies to support clinical development. You will learn about various topics including special populations, line extensions, predictive value of non-clinical studies, risk assessment of non-clinical studies, CTD Module 4 and the non-clinical part of Module 2.

You will also get an overview of how to put together a Common Technical Document for the non-clinical part of a registration dossier (e.g. CTD Module 2 and 4). 
 

Keywords

Overview of pharmacology, pharmacokinetics and toxicology
Timing of non-clinical studies
Pharmacology
Pharmacokinetics
General toxicity studies
Local tolerance and other studies
Application for first-dose-in-man
Carcinogenicity
Reproduction — including juvenile toxicity
Immunotoxicity
Interaction with quality (CTD Module 3)
Biotechnology products
Implications of non-clinical findings for the EU and FDA labeling text
Life cycle management
Selection of animal species and predictive value of non-clinical studies
Risk assessment — Industry and regulatory body view

What you will learn

  1. The purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
  2. How to select the right studies at the right time to meet the company’s needs and regulatory requirements and how to evaluate the results and find the predictive value of them
  3. How to put together the non-clinical part of a registration dossier
  4. How to analyze non-clinical requirements for specific types of medicine, clinical indications and implications in relation to the composition and conduct of the non-clinical safety study programme
  5. Best practices when interacting with non-clinical specialists as well as with clinicians, CMC specialists and the regulatory agencies in order to ensure that non-clinical safety information is generated, interpreted and communicated correctly to the benefit of patient safety

What your company will get

  1. A regulatory professional who understands the purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
  2. A regulatory affairs professional who is able to analyze non-clinical requirements for specific types of medicines and thereby contribute to the composition and conduct of the non-clinical safety study programme from a regulatory point of view
  3. A regulatory affairs professional who is able to interact with non-clinical specialists and regulatory agencies to ensure that non-clinical safety information is generated, interpreted and communicated correctly
Available start dates
All course dates: 15. Sep 2020, 16. Sep 2020, 17. Sep 2020
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Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick and cannot attend the course, you may hand over the seat to a colleague, who will then have to register for the course on our website prior to course start. If the registration is closed, please send us full name, email, phone and title of your colleague to bfl@atriumcph.com. Read our cancellation policy.

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This course is a part of this programme

Regulatory Affairs Diploma

Theoretical and practical aspects ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

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

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