Summary
Module 7
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 & lecturers
- Jens Thing MortensenCourse leaderSr. Director, Non-Clinical Safety
Genmab A/S - Peter Ravn BrinckCourse leaderSenior Principal Scientist, Safety Sciences and Imaging
Novo Nordisk A/S - Gerd BodeLecturerProf. Dr. FACP, PhD / Consultant
Gerd Bode - Independent Consultant - Allan Dahl RasmussenLecturerDirector, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S - Kari KaaberLecturerSenior Scientist
Scantox A/S - David TweatsLecturerGenetic Toxicology Consultant
Atrium - Pernille Barbre ChristophersenLecturerPhD Principal Clinical Pharmacology Specialist
Novo Nordisk A/S - Jonas HenningsenLecturerVP Regulatory Affairs
Alligator Bioscience AB - Henry StemplewskiLecturerPharmacotoxicologist and Preclinical Assessor
MHRA - Medicines & Healthcare Products, Regulatory Agency - Jane StewartLecturerBSc, BVM&S, Ph.D., MRCVS, ERT, Toxicologist
ApconiX Limited - Andrew MakinLecturerCEO
Andrew Makin Preclinical Consulting ApS - Kirsty HarperLecturerNon-Clinical Safety Lead
UCB - Gitte FrausingLecturerFrausing, M.Sc Biology, M.Sc Applied Toxicology, Principal Consultant
Data Standards Decisions Aps - Paul BaldrickLecturerExecutive Director
Labcorp Drug Development, UK - David DavidRJonesLecturerBSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
UNKNOWN - Robert Michael BaldwinLecturerPhD, Principal Scientist PKPD & DMPK
Novo Nordisk A/S - Luc de SchaepdrijverLecturerDVM, PhD, Senior Toxicologist
Unknown - Lesley ReeveLecturerSenior Director, Regulatory Strategy
Labcorp - Tomas MowLecturerPrincipal Scientist, DVM, PhD, DSP, ERT
Novo Nordisk A/S
Is this course for you?
This course is for you if you are an experienced Regulatory Affairs professional, employed in the industry, a regulatory agency, or a consulting firm.
What you will learn
- The purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
- 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
- How to put together the non-clinical part of a registration dossier
- 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
- 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
- A regulatory professional who understands the purpose of each category of the non-clinical safety studies needed to support clinical development of Pharmaceuticals
- 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
- 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
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
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
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
Registration
Registration deadline7 Feb 2024
Lersø Parkallé 101
2100 København Ø
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 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 10% 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 a diploma
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
Genmab A/S
Novo Nordisk A/S
Lecturers
Gerd Bode - Independent Consultant
H. Lundbeck A/S
Scantox A/S
Atrium
Novo Nordisk A/S
Alligator Bioscience AB
MHRA - Medicines & Healthcare Products, Regulatory Agency
ApconiX Limited
Andrew Makin Preclinical Consulting ApS
UCB
Data Standards Decisions Aps
Labcorp Drug Development, UK
UNKNOWN
Novo Nordisk A/S
Unknown
Labcorp
Novo Nordisk A/S
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