Module 8
Summary
This module will provide you with an overview of the regulatory aspects of global clinical development processes and the documentation needed for the clinical sections of CTD (Modules 2 and 5). The clinical sections are especially important when completing a marketing authorization of a new product or when labeling a product. The sections are also important in helping you meet the needs of patients and also when marketing the product.
The module is relevant for you if you are a regulatory employee who wishes to gain a better understanding of the interrelationships and complexities in clinical development and the current regulatory requirements for developing a new treatment. Our course also provides clinical development staff with the opportunity to gain a better understanding of the relationship between regulatory and clinical strategies as well as the documents that must be prepared prior to regulatory approval.
OTHER COURSE PARTICIPANTS SAY:
"The course was well-structured with many really relevant topics and interesting presenters. This course really helps put together the bigger picture when working with clinical development."
Malene Olesen, Senior Regulatory Professional.
Keywords
- Global clinical development
- Global regulatory requirements
- Clinical study
- Early clinical development
- Clinical efficacy and safety trials
- Target product profile
- Biomarkers as clinical endpoints
- Pharmacokinetic, pharmacodynamics and special populations
- Clinical protocol
- Interactions and drug/drug interactions
- Statistics in clinical trials
- Pediatric development
- Clinical summaries and clinical overview
- Benefit-risk assessment tools
- Post-approval studies
- Pharmacovigilance
- Health Technology Assessment (HTA)
- Interactions with health authorities
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
PLEASE NOTE:
As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.
Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.
Course leader(s) & Lecturer(s)
- Dorte Bjørn-LarsenCourse leaderSenior Regulatory Affairs Manager
Novo Nordisk A/S - Christina Balslev RindshøjCourse leaderSenior Director
Ozack ApS - Christina RindshøjCourse leaderSenior Director
Ozack ApS - Stefan HerdiniusLecturerExecutive Regulatory Science Director, Early Respiratory & Immunology
AstraZeneca AB, Sweden - Jeannet KnudsenLecturerLead GCP Auditor
Novo Nordisk A/S - Joris WilmsLecturerChief Operating Officer
Atrium - Tina ZinckLecturerRegulatory Affairs Project Director
Novo Nordisk A/S - Kirsten DahlLecturerClinical Pharmacology Director
Novo Nordisk A/S - Michael BeckertLecturerConsultant
CaRACS Michael Beckert Consulting - Tine Aggerholm BækdalLecturerSenior Clinical Pharmacology Advisor
Novo Nordisk A/S - Ida Katrine LundLecturerGlobal Regulatory Lead
Novo Nordisk A/S - Lars EndahlLecturerMSc, PhD, EMM, Statistical Vice President, Biostatistics
Novo Nordisk A/S - Louise BuurLecturerClinical Pharmacology Senior Specialist, Clinical Pharmacology
H. Lundbeck A/S - Jens HeisterbergLecturerVP, Regulatory Policy and Intelligence
Novo Nordisk A/S - Eva BøgeLecturerRegulatory Project Manager
Zealand Pharma A/S - Samuel David RamsdenLecturerHead of Risk Management Office
Boehringer Ingelheim Pharma GmbH & Co. KG - Jane Møll PedersenLecturerDirector
Novo Nordisk A/S - Janina KarresLecturerScientific Officer
EMA - European Medicines Agency - Jannik NielsenLecturerSenior Safety Surveillance Adviser, Global Safety
Novo Nordisk A/S - Mette Duelund SimonsenLecturerSafety Surveillance Manager
Novo Nordisk A/S - Jeff CravenLecturerPrincipal Medical Writer
Contura International - Martin Strandberg-LarsenLecturerSenior Director Market Access
Veracyte Inc. - Alice Bjerregaard LarsenLecturerManager
LEO Pharma A/S - Trine MoulvadLecturerVP
Zealand Pharma A/S - Steven JohnsonLecturerHead of US Regulatory Affairs
UCB - Martin FriedrichsenLecturerM.Sc., PhD, Senior Clinical Pharmacology Scientist, Clinical Pharmacology Obesity
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
- To create, analyze and evaluate a regulatory strategy plan for the clinical development of a new drug
- To understand the principles of clinical development from phase I to IV
- To learn how to create competitive product information by optimizing the clinical development plan and supporting the desired labeling
What your company will get
- A regulatory professional who is able to analyze and evaluate a regulatory strategy plan for the clinical development of a new drug
- A regulatory affairs professional who has a good understanding of the interrelationships and complexities in clinical Development
- A regulatory affairs professional who is able to challenge and ask the right questions with respect to the clinical related documentation
Course calendar
DAY 1
- Global clinical development
- Global regulatory requirements and new trends
- Clinical study
- Workshop 1 – GCP in clinical development
- Early clinical development
- Clinical efficacy and safety trials
- Pharmacokinetics & pharmacodynamics
- Workshop 2 - Clinical protocol
DAY 2
- Special populations
- Interactions and drug/drug interactions
- Statistics in clinical trials
- Workshop 3
- Biomarkers as clinical endpoints
- Target product profile – Global focus
- Product information texts – summary of product characteristics (SMPC)
DAY 3
- Paediatrics development
- Benefit-risk – assessment tools
- Workshop 4 – benefit/Risk case
- Clinical summaries
- Clinical overview
- Single pivotal trial approvals
- Post-approval studies
- Integrated clinical study report (ICH e 3)
- Content and structure of the clinical study report (CSR)
- Workshop 5 – late phase development
DAY 4
- Pharmacovigilance
- HTA
- Workshop 6 – Drug safety
- Interactions with health authorities
Registration
Registration deadline27 Sep 2022
Lersø Parkallé 101
2100 København Ø
DAY 1
- Global clinical development
- Global regulatory requirements and new trends
- Clinical study
- Workshop 1 – GCP in clinical development
- Early clinical development
- Clinical efficacy and safety trials
- Pharmacokinetics & pharmacodynamics
- Workshop 2 - Clinical protocol
DAY 2
- Special populations
- Interactions and drug/drug interactions
- Statistics in clinical trials
- Workshop 3
- Biomarkers as clinical endpoints
- Target product profile – Global focus
- Product information texts – summary of product characteristics (SMPC)
DAY 3
- Paediatrics development
- Benefit-risk – assessment tools
- Workshop 4 – benefit/Risk case
- Clinical summaries
- Clinical overview
- Single pivotal trial approvals
- Post-approval studies
- Integrated clinical study report (ICH e 3)
- Content and structure of the clinical study report (CSR)
- Workshop 5 – late phase development
DAY 4
- Pharmacovigilance
- HTA
- Workshop 6 – Drug safety
- Interactions with health authorities
Registration
Registration deadline26 Sep 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 usually held 4-6 weeks after the course.
It is a digital exam in the University of Copenhagen’s digital exam system.
This course is a part of this programme
Are you a regulatory affairs professional and are you concerned with your ongoing learning and development consider these courses, offered in development with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA)
Read moreRegulatory 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
Read moreCourse leader(s)
Novo Nordisk A/S
Ozack ApS
Ozack ApS
Lecturer(s)
AstraZeneca AB, Sweden
Novo Nordisk A/S
Atrium
Novo Nordisk A/S
Novo Nordisk A/S
CaRACS Michael Beckert Consulting
Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk A/S
H. Lundbeck A/S
Novo Nordisk A/S
Zealand Pharma A/S
Boehringer Ingelheim Pharma GmbH & Co. KG
Novo Nordisk A/S
EMA - European Medicines Agency
Novo Nordisk A/S
Novo Nordisk A/S
Contura International
Veracyte Inc.
LEO Pharma A/S
Zealand Pharma A/S
UCB
Novo Nordisk A/S
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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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