Non-Clinical Development and Documentation, module 7

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

15 - 17 Nov 2023

On location

English

19,550 DKK ex VAT

(app. 2,628 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

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Course leader(s) & Lecturer(s)

  • Jens Thing Mortensen
    Course leader
    Sr. Director, Non-Clinical Safety
    Genmab A/S
  • Peter Ravn Brinck
    Course leader
    Senior Principal Scientist, Safety Sciences and Imaging
    Novo Nordisk A/S
  • Gerd Bode
    Lecturer
    Prof. Dr. FACP, PhD / Consultant
    Gerd Bode - Independent Consultant
  • Allan Dahl Rasmussen
    Lecturer
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
  • Kari Kaaber
    Lecturer
    Senior Scientist
    Scantox A/S
  • David Tweats
    Lecturer
    Genetic Toxicology Consultant
    Atrium
  • Pernille Barbre Christophersen
    Lecturer
    PhD Principal Clinical Pharmacology Specialist
    Novo Nordisk A/S
  • Jonas Henningsen
    Lecturer
    VP Regulatory Affairs
    Alligator Bioscience AB
  • Henry Stemplewski
    Lecturer
    Pharmacotoxicologist and Preclinical Assessor
    MHRA - Medicines & Healthcare Products, Regulatory Agency
  • Jane Stewart
    Lecturer
    BSc, BVM&S, Ph.D., MRCVS, ERT, Toxicologist
    ApconiX Limited
  • Andrew Makin
    Lecturer
    CEO
    Andrew Makin Preclinical Consulting ApS
  • Kirsty Harper
    Lecturer
    Non-Clinical Safety Lead
    UCB
  • Gitte Frausing
    Lecturer
    Frausing, M.Sc Biology, M.Sc Applied Toxicology, Principal Consultant
    Data Standards Decisions Aps
  • Paul Baldrick
    Lecturer
    Executive Director, Regulatory Strategy, Global Regulatory Affairs
    Covance
  • David DavidRJones
    Lecturer
    BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
    UNKNOWN
  • Robert Michael Baldwin
    Lecturer
    PhD, Principal Scientist PKPD & DMPK
    Novo Nordisk A/S
  • Luc de Schaepdrijver
    Lecturer
    DVM, PhD, Senior Toxicologist
    Unknown
  • Lesley Reeve
    Lecturer
    Director, Regulatory Strategy
    Labcorp
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

Starting 15 Nov 2023
15 Nov 2023 8:30-18:00

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
16 Nov 2023 8:00-17:45

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
17 Nov 2023 8:00-16:15

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

14 Dec 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
18 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
15 - 17 Nov
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 held online, usually 4-6 weeks after the course.

 You will receive a link with exam questions via your personal Atrium log-in.

 In order to participate in the exam, you must have attended the course.

This course is a part of this programme

Diploma in Regulatory Affairs

This diploma in regulatory affairs 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)

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

Lecturer(s)

Gerd Bode
Prof. Dr. FACP, PhD / Consultant
Gerd Bode - Independent Consultant
Allan Dahl Rasmussen
Director, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S
Kari Kaaber
Senior Scientist
Scantox A/S
David Tweats
Genetic Toxicology Consultant
Atrium
Pernille Barbre Christophersen
PhD Principal Clinical Pharmacology Specialist
Novo Nordisk A/S
Jonas Henningsen
VP Regulatory Affairs
Alligator Bioscience AB
Henry Stemplewski
Pharmacotoxicologist and Preclinical Assessor
MHRA - Medicines & Healthcare Products, Regulatory Agency
Jane Stewart
BSc, BVM&S, Ph.D., MRCVS, ERT, Toxicologist
ApconiX Limited
Andrew Makin
CEO
Andrew Makin Preclinical Consulting ApS
Kirsty Harper
Non-Clinical Safety Lead
UCB
Gitte Frausing
Frausing, M.Sc Biology, M.Sc Applied Toxicology, Principal Consultant
Data Standards Decisions Aps
Paul Baldrick
Executive Director, Regulatory Strategy, Global Regulatory Affairs
Covance
David DavidRJones
BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
UNKNOWN
Robert Michael Baldwin
PhD, Principal Scientist PKPD & DMPK
Novo Nordisk A/S
Luc de Schaepdrijver
DVM, PhD, Senior Toxicologist
Unknown
Lesley Reeve
Director, Regulatory Strategy
Labcorp

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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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