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) & Lecturer(s)
- Anne Vinding SillemannCourse leaderRegulatory Principal Specialist, RA Rare Endocrine Disorders
Novo Nordisk A/S - Helen ShennanCourse leaderReguatory Affairs Head Nordic
AstraZeneca A/S - Ann Christine KorsgaardLecturerCEO, Regulatory Executive
Ozack ApS - Lars Sparre ConradLecturerPhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
H. Lundbeck A/S - Martin Strandberg-LarsenLecturerSenior Director Market Access
Veracyte Inc. - Eva BøgeLecturerRegulatory Project Manager
Zealand Pharma A/S - Stefan HerdiniusLecturerExecutive Regulatory Science Director, Early Respiratory & Immunology
AstraZeneca AB, Sweden - 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 KongstadLecturerVP & Global Program Head, Tralokinumab
Leo Pharma A/S
IS THIS COURSE FOR YOU?
You have a minimum of 2 years regulatory affairs experience, and you would like to improve your regulatory competencies.
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
- The role of regulatory affairs
- Introduction to regulatory strategy
- Target labelling – key elements, sources of information and the studies
- Regulatory strategy plan - the clinical studies supporting the target labelling
- Intellectual Property (IP) – activities in the pharma world
- Group work
DAY 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan – non-clinical
- Regulatory strategy plan – CMC development strategy
- Group Work
DAY 3
- Development of a regulatory strategy – practical example
- Life cycle management strategies
- Communication and yourself
- Group work
Registration
Registration deadline24 Aug 2022
Lersø Parkallé 101
2100 København Ø
DAY 1
- The role of regulatory affairs
- Introduction to regulatory strategy
- Target labelling – key elements, sources of information and the studies
- Regulatory strategy plan - the clinical studies supporting the target labelling
- Intellectual Property (IP) – activities in the pharma world
- Group work
DAY 2
- Regulatory strategies and strategic considerations with focus on the USA
- Regulatory strategies and strategic considerations with focus on the EU
- Regulatory strategy plan – non-clinical
- Regulatory strategy plan – CMC development strategy
- Group Work
DAY 3
- Development of a regulatory strategy – practical example
- Life cycle management strategies
- Communication and yourself
- Group work
Registration
Registration deadline26 Apr 2023
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will receive information about mandatory and optional readings. Please familiarize yourself with the mandatory reading before starting the course. The mandatory reading is also a 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.
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)
Novo Nordisk A/S
AstraZeneca A/S
Lecturer(s)
AstraZeneca A/S
Ozack ApS
H. Lundbeck A/S
Veracyte Inc.
Zealand Pharma A/S
AstraZeneca AB, Sweden
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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