Global Regulatory Strategies, module 5

Regulatory strategic considerations during global drug development

24 - 26 May 2023

On location

English

18,450 DKK ex VAT

(app. 2,481 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

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Course leader(s) & Lecturer(s)

  • Anne Vinding Sillemann
    Course leader
    Regulatory Principal Specialist, RA Rare Endocrine Disorders
    Novo Nordisk A/S
  • Helen Shennan
    Course leader
    Reguatory Affairs Head Nordic
    AstraZeneca A/S
  • Ann Christine Korsgaard
    Lecturer
    CEO, Regulatory Executive
    Ozack ApS
  • Lars Sparre Conrad
    Lecturer
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
  • Martin Strandberg-Larsen
    Lecturer
    Senior Director Global Market Access & Health Economics
    Veracyte Inc.
  • Eva Bøge
    Lecturer
    Regulatory Project Manager
    Zealand Pharma A/S
  • Stefan Herdinius
    Lecturer
    Head Global Regulatory Affairs
    Unknown
  • Allan Dahl Rasmussen
    Lecturer
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
  • Mette Maegaard Sonne
    Lecturer
    Director
    Ferring Pharmaceuticals A/S
  • Dorte Bjørn-Larsen
    Lecturer
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
  • Maiken Gy Kongstad
    Lecturer
    VP & Global Program Head, Tralokinumab
    Leo Pharma A/S
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 24 May 2023
24 May 2023 8:30-18:00

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
25 May 2023 8:15-16:15

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
    26 May 2023 8:15-14:30

    DAY 3

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

    Related exams

    15 Jun 2023 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    26 Apr 2023
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    24 - 26 May
    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

    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

    Diploma in Regulatory Affairs

    This diploma in regulatory affairs 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 more

    Course leader(s)

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

    Lecturer(s)

    Helen Shennan
    Reguatory Affairs Head Nordic
    AstraZeneca A/S
    Ann Christine Korsgaard
    CEO, Regulatory Executive
    Ozack ApS
    Lars Sparre Conrad
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
    Martin Strandberg-Larsen
    Senior Director Global Market Access & Health Economics
    Veracyte Inc.
    Eva Bøge
    Regulatory Project Manager
    Zealand Pharma A/S
    Stefan Herdinius
    Head Global Regulatory Affairs
    Unknown
    Allan Dahl Rasmussen
    Director, Head of Regulatory Toxicology & Safety Assessment
    H. Lundbeck A/S
    Mette Maegaard Sonne
    Director
    Ferring Pharmaceuticals A/S
    Dorte Bjørn-Larsen
    Senior Regulatory Affairs Manager
    Novo Nordisk A/S
    Maiken Gy Kongstad
    VP & Global Program Head, Tralokinumab
    Leo Pharma A/S

    You may also be interested in these courses

    WANT TO KNOW MORE OR NEED HELP?

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

    Send ME A MESSAGE