Global Regulatory Strategies, module 5

Regulatory strategic considerations during global drug development

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22 - 24 May 2024

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On location

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English

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19,200 DKK ex VAT

(app. 2,581 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

Module 5

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 three day 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 & lecturers

  • Anne Vinding Sillemann
    Course leader
    Regulatory Principal Specialist, GRL, RA Rare Endocrine Disorders
    Novo Nordisk A/S
  • Helen Shennan
    Course leader
    Regulatory Affairs Director
    AstraZeneca A/S
  • Mette Maegaard Sonne
    Lecturer
    Director
    Ferring Pharmaceuticals A/S
  • Martin Bostrup
    Lecturer
    PhD, Senior Director Market Access
    Veracyte Inc.
  • Lars Sparre Conrad
    Lecturer
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
  • Jens Thing Mortensen
    Lecturer
    Sr. Director, Non-Clinical Safety
    Genmab A/S
  • Annette Mattsson
    Lecturer
    Vice President Regulatory Affairs
    Camurus AB
  • Anne Louise Kirkegaard
    Lecturer

    FluoGuide A/S
  • Alma Sahl
    Lecturer
    Regulatory Specialist, Global Regulatory Lead
    Novo Nordisk A/S
See all

Is this course for you?

This course is for you if you are an experienced Regulatory Affairs professional, employed in the industry, a regulatory agency, or a consulting firm.

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 22 May 2024
22 May 2024 8:30-17:00
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
23 May 2024 8:15-16:10
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
    24 May 2024 8:30-15:30
    Day 3
    • Development of a regulatory strategy – practical example
    • Life cycle management strategies
    • Communication and yourself
    • Group work
    Practical information

    Related exams

    20 Jun 2024 10:00-13:00
    Go to exam page

    Registration

    Registration deadline
    14 May 2024
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    22 - 24 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 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 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 a diploma

    Diploma in Regulatory Affairs

    The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

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    Course leaders

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

    Lecturers

    Mette Maegaard Sonne
    Director
    Ferring Pharmaceuticals A/S
    Martin Bostrup
    PhD, Senior Director Market Access
    Veracyte Inc.
    Lars Sparre Conrad
    PhD, European Patent Attorney, Chief Patent Specialist, Corporate Patents & Trademarks
    H. Lundbeck A/S
    Helen Shennan
    Regulatory Affairs Director
    AstraZeneca A/S
    Jens Thing Mortensen
    Sr. Director, Non-Clinical Safety
    Genmab A/S
    Annette Mattsson
    Vice President Regulatory Affairs
    Camurus AB
    Anne Louise Kirkegaard

    FluoGuide A/S
    Alma Sahl
    Regulatory Specialist, Global Regulatory Lead
    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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