Non-clinical Development and Documentation

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

8. Dec 2021
23. Nov 2022

3 days course

English

18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

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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Course leader(s) & Lecturers

  • Peter Ravn Brinck
    Course leader
    Senior Principal Scientist, Safety Sciences and Imaging
    Novo Nordisk A/S
  • Jens Thing Mortensen
    Course leader
    Sr. Director, Non-Clinical Safety
    Genmab A/S
  • Gerd Bode
    Lecturer
    Prof. Dr. FACP, PhD / Consultant
    Atrium
  • Kari Kaaber
    Lecturer

    Charles River Copenhagen (CitoxLAB Scantox A/S)
  • David Tweats
    Lecturer
    Genetic Toxicology Consultant
    Atrium
  • Jonas Henningsen
    Lecturer
    Director, Head of Regulatory Science
    H. Lundbeck A/S
  • Jane Stewart
    Lecturer
    Toxicologist
    Atrium
  • Björn Dahl
    Lecturer
    Senior Toxicologist
    Atrium
  • Andrew Makin
    Lecturer
    CEO
    Andrew Makin Preclinical Consulting ApS
  • Kirsty Harper
    Lecturer
    Non-Clinical Safety Lead
    UCB
  • Paul Baldrick
    Lecturer
    Executive Director, Regulatory Strategy, Global Regulatory Affairs
    Atrium
  • David Jones
    Lecturer
    BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist
    MHRA - Medicines & Healthcare Products, Regulatory Agency
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. 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

Course calendar

Choose your starting date
Starting 8. Dec 2021
Starting 23. Nov 2022
8. Dec 2021 9:00-16:00

DAY 1

  • CTD: Overview of pharmacology, pharmacokinetics and toxicology
  • Timing of non-clinical studies
  • Pharmacology
  • Pharmacokinetics
  • General toxicity studies including immunotoxicity
  • Genotoxicity
  • Local tolerance and other studies
  • Group work
9. Dec 2021 9:00-16:00

DAY 2

  • Interaction with clinical (CTD module 5)
  • Application for first-dose-in-man
  • Interaction with quality (CTD module 3)
  • Reproduction
  • Juvenile toxicity
  • Carcinogenicity
  • Biotechnology products
  • Group work
10. Dec 2021 9:00-16:00

DAY 3

  • Life cycle management
  • Implications of non-clinical findings for the EU and FDA labeling text
  • Risk assessment — Regulatory body and industry view
  • Group work
Practical information

Related exams

11. Jan 2022 10:00-13:00
Go to exam page

Registration

Registration deadline
10. Nov 2021
Atrium
Lersø Parkallé 101
2100 København Ø
23. Nov 2022 9:00-16:00

DAY 1

  • CTD: Overview of pharmacology, pharmacokinetics and toxicology
  • Timing of non-clinical studies
  • Pharmacology
  • Pharmacokinetics
  • General toxicity studies including immunotoxicity
  • Genotoxicity
  • Local tolerance and other studies
  • Group work
24. Nov 2022 9:00-16:00

DAY 2

  • Interaction with clinical (CTD module 5)
  • Application for first-dose-in-man
  • Interaction with quality (CTD module 3)
  • Reproduction
  • Juvenile toxicity
  • Carcinogenicity
  • Biotechnology products
  • Group work
25. Nov 2022 9:00-16:00

DAY 3

  • Life cycle management
  • Implications of non-clinical findings for the EU and FDA labeling text
  • Risk assessment — Regulatory body and industry view
  • Group work
Practical information

Related exams

31. Jan 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
26. Oct 2022
Atrium
Lersø Parkallé 101
2100 København Ø
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, and you can therefore take the exam in your own country from any location that provides adequate internet access. 

This course is a part of this programme

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

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Course leader(s)

Peter Ravn Brinck
Senior Principal Scientist, Safety Sciences and Imaging
Novo Nordisk A/S
Jens Thing Mortensen
Sr. Director, Non-Clinical Safety
Genmab A/S

Lecturers

Gerd Bode
Prof. Dr. FACP, PhD / Consultant
Atrium
Kari Kaaber

Charles River Copenhagen (CitoxLAB Scantox A/S)
David Tweats
Genetic Toxicology Consultant
Atrium
Jonas Henningsen
Director, Head of Regulatory Science
H. Lundbeck A/S
Jane Stewart
Toxicologist
Atrium
Björn Dahl
Senior Toxicologist
Atrium
Andrew Makin
CEO
Andrew Makin Preclinical Consulting ApS
Kirsty Harper
Non-Clinical Safety Lead
UCB
Paul Baldrick
Executive Director, Regulatory Strategy, Global Regulatory Affairs
Atrium
David Jones
BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist
MHRA - Medicines & Healthcare Products, Regulatory Agency

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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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