Global Regulatory Strategies, module 5

Regulatory strategic considerations during global drug development
21 Sep 2022
24 May 2023

3 days course

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 Market Access
    Veracyte Inc.
  • Eva Bøge
    Lecturer
    Regulatory Project Manager
    Zealand Pharma A/S
  • Stefan Herdinius
    Lecturer
    Executive Regulatory Science Director, Early Respiratory & Immunology
    AstraZeneca AB, Sweden
  • 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

Choose your starting date
Starting 21 Sep 2022
Starting 24 May 2023
21 Sep 2022 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
22 Sep 2022 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
    23 Sep 2022 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

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

    Registration

    Registration deadline
    24 Aug 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    21 - 23 Sep
    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

      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

      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 Market Access
      Veracyte Inc.
      Eva Bøge
      Regulatory Project Manager
      Zealand Pharma A/S
      Stefan Herdinius
      Executive Regulatory Science Director, Early Respiratory & Immunology
      AstraZeneca AB, Sweden
      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

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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