Global Regulatory Strategies

Regulatory strategic considerations during global drug development

21. Sep 2022

3 days course

English

18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

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

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

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Course leader(s) & Lecturers

  • Anne Vinding Sillemann
    Course leader
    Regulatory Principal Specialist, RA Rare Endocrine Disorders
    Novo Nordisk A/S
  • Helen Shennan
    Course leader
    Regulatory Affairs Head
    AstraZeneca A/S
  • Allan Dahl Rasmussen
    Lecturer
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
  • Ann Christine Korsgaard
    Lecturer
    CEO, Regulatory Executive
    OZACK
  • Daniel Brath
    Lecturer
    Head of IVS
    AstraZeneca A/S
  • Dorte Bjørn-Larsen
    Lecturer
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
  • Eva Bøge
    Lecturer
    Senior Regulatory Project Manager
    Zealand Pharma A/S
  • Lars Sparre Conrad
    Lecturer
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
  • Maiken Gy Kongstad
    Lecturer
    LCM Portfolio Director, R&D Program & Portfolio Leadership
    LEO Pharma A/S
  • Mette Maegaard Sonne
    Lecturer
    Senior Manager
    Ferring Pharmaceuticals A/S
  • Stefan Herdinius
    Lecturer
    Executive Regulatory Science Director, Early Respiratory & Immunology
    AstraZeneca AB, Sweden
See all

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

  1. How to develop a regulatory strategy for products in various stages of the product life cycle
  2. How to analyze strengths and weaknesses of a product in order to develop regulatory strategies and target product profiles
  3. How to use best practices when communicating a regulatory strategy to the company project team or top management
  4. 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

  1. A regulatory professional who can play an active, effective and crucial part in the entire development and decision-making process
  2. A regulatory professional who can develop a regulatory strategy for products in various stages of the product life cycle
  3. A regulatory affairs professional who can communicate a regulatory strategy to the company project team or top management
  4. A regulatory affairs professional who can operate in a highly dynamic and constantly changing environment

Course calendar

Starting 21. Sep 2022
21. Sep 2022 9:00-16:00

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
22. Sep 2022 9:00-16:00

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
    23. Sep 2022 9:00-16:00

    DAY 3

    • Development of a regulatory strategy – practical example
    • Life cycle management strategies
    • Communication and yourself
    • Group work
    Practical information

    Related exams

    31. Oct 2022 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    24. Aug 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Sometimes things change. This is the expected programme.

    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

    Examination will take place about 4-6 weeks after the course. The exam is online.

    This course is a part of this programme

    Regulatory 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

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    Course leader(s)

    Anne Vinding Sillemann
    Regulatory Principal Specialist, RA Rare Endocrine Disorders
    Novo Nordisk A/S
    Helen Shennan
    Regulatory Affairs Head
    AstraZeneca A/S

    Lecturers

    Allan Dahl Rasmussen
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
    Ann Christine Korsgaard
    CEO, Regulatory Executive
    OZACK
    Daniel Brath
    Head of IVS
    AstraZeneca A/S
    Dorte Bjørn-Larsen
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
    Eva Bøge
    Senior Regulatory Project Manager
    Zealand Pharma A/S
    Helen Shennan
    Regulatory Affairs Head
    AstraZeneca A/S
    Lars Sparre Conrad
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
    Maiken Gy Kongstad
    LCM Portfolio Director, R&D Program & Portfolio Leadership
    LEO Pharma A/S
    Mette Maegaard Sonne
    Senior Manager
    Ferring Pharmaceuticals A/S
    Stefan Herdinius
    Executive Regulatory Science Director, Early Respiratory & Immunology
    AstraZeneca AB, Sweden

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    WANT TO KNOW MORE OR NEED HELP?

    Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

    Send ME A MESSAGE