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 MortensenCourse leaderSr. Director, Non-Clinical Safety
Genmab A/S - Peter Ravn BrinckCourse leaderSenior Principal Scientist, Safety Sciences, Imaging and Data Management
Novo Nordisk A/S - Gerd Dr. 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 and Study Director,
Scantox A/S - David TweatsLecturerGenetic Toxicology Consultant
Atrium - Pernille Barbre ChristophersenLecturerPhD, Clinical Pharmacology Specialist, Early Clinical Pharmacology
Novo Nordisk A/S - Jonas HenningsenLecturerDirector, Head of Regulatory Science
H. Lundbeck A/S - Henry StemplewskiLecturerPharmacotoxicologist and Preclinical Assessor
Atrium - Jane StewartLecturerToxicologist
Atrium - Björn DahlLecturerSenior Toxicologist
Atrium - Andrew MakinLecturerCEO, Andrew Makin Preclinical Consulting
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, Regulatory Strategy, Global Regulatory Affairs
Atrium - David JonesLecturerBSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
UNKNOWN - Robert Michael BaldwinLecturerPhD, Principal Scientist PKPD & DMPK
Novo Nordisk A/S
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
- 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 deadline26 Oct 2022
Lersø Parkallé 101
2100 København Ø
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 deadline18 Oct 2023
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
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
Read moreCourse leader(s)
Genmab A/S
Novo Nordisk A/S
Lecturer(s)
Gerd Bode - Independent Consultant
H. Lundbeck A/S
Scantox A/S
Atrium
Novo Nordisk A/S
H. Lundbeck A/S
Atrium
Atrium
Atrium
Andrew Makin Preclinical Consulting ApS
UCB
Data Standards Decisions Aps
Atrium
UNKNOWN
Novo Nordisk A/S
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