Module 5
Summary
As a regulatory affairs expert, you play an active part in the entire drug development process. This is crucial if you wish to develop new and effective drugs, and at the same time meet the expectations of a faster and more efficient drug development process.
On this course, you will delve deep into regulatory decisions and strategies and get an in-depth understanding of how and why they are made. Regulatory courses normally focus on laws, guidelines, and directives, but offer little insight on the role of regulatory experts in project teams. Our course delves much deeper into the guidelines and explores the background of global regulatory strategies and the preceding considerations. If you are a regulatory affairs employee, then you will benefit greatly from this insight, which will be delivered by a number of internationally experienced lecturers.
Keywords
- Regulatory Affairs Involvement in Product Development
- Regulatory Strategies
- Consultation with Authorities Throughout Development
- Regulatory Intelligence
- The Development of a Target Label
- Regulatory Planning
- Intellectual Property Rights
- Pricing and Reimbursement Negotiations
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Course leader(s) & Lecturers
- Helen ShennanCourse leaderRegulatory Affairs Director
AstraZeneca A/S - Anne Vinding SillemannCourse leaderSenior Global Regulatory Lead
Novo Nordisk A/S - AnnChristine Christine KorsgaardLecturerCEO
OZACK - Lars Sparre ConradLecturerPhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
H. Lundbeck A/S - Daniel BrathLecturerHead of IVS
Atrium - Eva BøgeLecturerSenior Regulatory Project Manager
Zealand Pharma A/S - Stefan HerdiniusLecturerExecutive Regulatory Science Director, Early Respiratory & Immunology
AstraZeneca A/S - Allan Dahl RasmussenLecturerDirector, Head of Regulatory Toxicology & Safety Assessment
H. Lundbeck A/S - Mette Maegaard SonneLecturerDirector
Ferring Pharmaceuticals A/S - Dorte Bjørn-LarsenLecturerSenior Regulatory Affairs Manager
Novo Nordisk A/S - Maiken Gy KongstadLecturerLCM Portfolio Director, Tralokinumab & Actinic Keratosis
LEO Pharma 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
- How to develop a regulatory strategy for products in various stages of the product life cycle
- How to analyze strengths and weaknesses of a product in order to develop regulatory strategies and target product profiles
- How to use best practices when communicating a regulatory strategy to the company project team or top management
- To operate in a dynamic and changing environment, where internal as well as external business partners and authorities must understand the rationale of the product development
What your company will get
- A regulatory professional who can play an active, effective and crucial part in the entire development and decision-making process
- A regulatory professional who can develop a regulatory strategy for products in various stages of the product life cycle
- A regulatory affairs professional who can communicate a regulatory strategy to the company project team or top management
- A regulatory affairs professional who can operate in a highly dynamic and constantly changing environment
Course calendar
DAY 1
- Introduction
- The role of Regulatory Affairs
- Introduction to regulatory strategy
- Target labeling
- Key elements, sources of information and the studies
- Regulatory strategy plan: The clinical studies supporting the target labeling
- Interllectual property (IP)
- Activites in the pharma world
- Group work 1
- Interllectual property
- Networking
DAY 2
- Summary of day 1 and introduction to day 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory Intelligence
- Pharmacoeconomics
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan: Case story
- Non-clinical
- Group work 2: Development of a regulatory strategy
- Practical example
DAY 3
- Summary of day 2 and introduction to day 3
- Regulatory strategy plan: CMC Development strategy
- Life cycle Management strategies
- Communication and yourself
- Group work 3: Implementation of the Regulatory strategy
- End of module 5
Registration
Registration deadline17. Aug 2021
Lersø Parkallé 101
2100 København Ø
DAY 1
- Introduction
- The role of Regulatory Affairs
- Introduction to regulatory strategy
- Target labeling
- Key elements, sources of information and the studies
- Regulatory strategy plan: The clinical studies supporting the target labeling
- Interllectual property (IP)
- Activites in the pharma world
- Group work 1
- Interllectual property
- Networking
DAY 2
- Summary of day 1 and introduction to day 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory Intelligence
- Pharmacoeconomics
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan: Case story
- Non-clinical
- Group work 2: Development of a regulatory strategy
- Practical example
DAY 3
- Summary of day 2 and introduction to day 3
- Regulatory strategy plan: CMC Development strategy
- Life cycle Management strategies
- Communication and yourself
- Group work 3: Implementation of the Regulatory strategy
- End of module 5
Registration
Registration deadline24. Aug 2022
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, 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 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 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
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)
AstraZeneca A/S
Novo Nordisk A/S
Lecturers
AstraZeneca A/S
OZACK
H. Lundbeck A/S
Atrium
Zealand Pharma A/S
AstraZeneca A/S
H. Lundbeck A/S
Ferring Pharmaceuticals A/S
Novo Nordisk A/S
LEO Pharma 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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