The EU Regulatory Environment - Procedures and Applications

EU Applications for Marketing Authorizations, Pediatric Investigation Plans, Clinical Trials and Orphan Drug Designation

28. Sep 2021
7. Sep 2022

3 days course

English

20,700 DKK ex VAT
(app. 2,783 EUR ex VAT)

Module 2

Summary

This module will provide you with a solid basis for evaluating the opportunities and consequences related to different types of products and submissions. It will also teach you how to plan and operate within the framework of the various application procedures.

While Module 1, "The Pharmaceutical Law Frameworks in the EU", provides you with knowledge of the pharmaceutical legislation in the EU, Module 2 focuses on the implementation of this legislation, e.g., on the procedural and operational aspects when applying for marketing authorizations, clinical trials and orphan drug designations in the EU. You will also learn how to comply with the EU requirements for pediatric investigation plans and risk management plans as well as how to obtain scientific advice from EU authorities.

Keywords

  • Regulatory Affairs in the EU
  • Marketing Authorization Applications
  • Scientific Advice
  • Post-Approval Activities
  • Pediatric Procedures
  • Clinical Trials Applications
  • Risk Management
  • Orphan Medicinal Products

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

    PLEASE NOTE:

    As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

    Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.

    Read more

    Course leader(s) & Lecturers

    • Eva Maiken Holck
      Course leader
      Regulatory Affairs Specialist RA CMC & Devise, Diabetes and Obesity
      UNKNOWN
    • Mette Due Theilade Thomsen
      Course leader
      Managing Director
      PIP adviser
    • Hans Hoogland
      Lecturer
      Senior Regulatory Intelligence Specialist
      LEO PHARMA A/S
    • Caroline Pothet
      Lecturer
      Regulatory Affairs Officer, Human Medicines - Committtees and Quality Assurance
      EMA - European Medicines Agency
    • Beatriz da Silva Lima
      Lecturer
      Professor of Pharmacology
      Universitet Lissabon (University of Lisbon)
    • Peter Bachmann
      Lecturer
      Head International Liaison Office and Conferences, Executive Department European Union and International Affairs
      Atrium
    • David King
      Lecturer
      Senior Director of Regulatory Affairs at HealxStirling, Scotland, United Kingdom
      Healx
    • Janina Karres
      Lecturer
      Scientific Officer
      EMA - European Medicines Agency
    • Ingrid Prieschl
      Lecturer
      Assoc. Director Regulatory Affairs
      MSD Oss
    • David Jones
      Lecturer
      BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist
      MHRA - Medicines & Healthcare Products, Regulatory Agency
    • Ida Palsberg Hummelmose
      Lecturer
      Global Senior Market Access Manager
      LEO PHARMA A/S
    • Samuel David Ramsden
      Lecturer
      Head of Risk Management Office
      Boehringer Ingelheim Pharma GmbH & Co. KG
    See all

    IS THIS COURSE FOR YOU?

    Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills. 

    What you will learn

    1. To understand the EU regulatory framework and the various types of applications and procedures
    2. How to evaluate the opportunities and consequences related to different types of products and submissions
    3. How to analyze the overall strategic choices for the regulatory procedures used during development, application, and maintenance of the medicinal product
    4. How to use best practices when handling various applications and procedures as well as when interacting with the European Authorities

    What your company will get

    1. A regulatory professional who understands and can operate within the framework of the various application procedures in the EU
    2. A regulatory professional who can evaluate and analyze the strategic choices related to different types of submissions
    3. A regulatory professional who can provide valuable input to the regulatory procedures used during the development, application, and maintenance of the medicinal product
    4. An employee who can play an important strategic role in any project team working on obtaining a marketing authorization in the EU

    Course calendar

    Choose your starting date
    Starting 28. Sep 2021
    Starting 7. Sep 2022
    28. Sep 2021 8:00-19:00

    DAY 1

    • Marketing Authorisation Applications – Overview, Terminology and Organisation
    • The Centralised Procedure – EMA Perspective
    • The Centralised Procedure - Examples of a discussion in CHMP
    • New Applications in the Decentralised/Mutual Recognition Procedure
    • Brexit – Aspects with regards to Medicinal Products
    • Group Work
    29. Sep 2021 8:00-17:00

    DAY 2

    • Scientific Advice from CHMP and National Competent Authorities
    • Group Exercise
    • Post Approval Activities
    • Paediatrics – Procedural Perspective
    • Paediatrics – Case Story
    • Group Work
    30. Sep 2021 8:00-16:30

    DAY 3

    • Clinical Trial Applications in a Pan-European View
    • Risk Management
    • Health Technology Assessment - HTA
    • Orphan Medicinal Products
    • Group Work
    Practical information

    Registration

    Registration deadline
    31. Aug 2021
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    7. Sep 2022 9:00-16:00

    DAY 1

    • Marketing Authorisation Applications – Overview, Terminology and Organisation
    • The Centralised Procedure – EMA Perspective
    • The Centralised Procedure - Examples of a discussion in CHMP
    • New Applications in the Decentralised/Mutual Recognition Procedure
    • Brexit – Aspects with regards to Medicinal Products
    • Group Work
    8. Sep 2022 9:00-16:00

    DAY 2

    • Scientific Advice from CHMP and National Competent Authorities
    • Group Exercise
    • Post Approval Activities
    • Paediatrics – Procedural Perspective
    • Paediatrics – Case Story
    • Group Work
    9. Sep 2022 9:00-16:00

    DAY 3

    • Clinical Trial Applications in a Pan-European View
    • Risk Management
    • Health Technology Assessment - HTA
    • Orphan Medicinal Products
    • Group Work
    Practical information

    Registration

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

    Course information

    Literature

    Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

    Please familiarize yourself with the mandatory readings before starting the course.

    The mandatory readings are also 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.

    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 20% 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 usually held 4-6 weeks after the course. It is a digital exam in the University of Copenhagen’s digital exam system. You can therefore take the exam in your own country.

    Please let us know if this is relevant for you as we can conduct exams at embassies, universities and so on worldwide.

    This course is a part of this programme

    Master of Medicines Regulatory Affairs (MRA)

    Are you a regulatory affairs professional and are you concerned with your ongoing learning and development consider these courses, offered in development with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA)

    Read more
    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)

    Eva Maiken Holck
    Regulatory Affairs Specialist RA CMC & Devise, Diabetes and Obesity
    UNKNOWN
    Mette Due Theilade Thomsen
    Managing Director
    PIP adviser

    Lecturers

    Hans Hoogland
    Senior Regulatory Intelligence Specialist
    LEO PHARMA A/S
    Caroline Pothet
    Regulatory Affairs Officer, Human Medicines - Committtees and Quality Assurance
    EMA - European Medicines Agency
    Beatriz da Silva Lima
    Professor of Pharmacology
    Universitet Lissabon (University of Lisbon)
    Peter Bachmann
    Head International Liaison Office and Conferences, Executive Department European Union and International Affairs
    Atrium
    David King
    Senior Director of Regulatory Affairs at HealxStirling, Scotland, United Kingdom
    Healx
    Janina Karres
    Scientific Officer
    EMA - European Medicines Agency
    Ingrid Prieschl
    Assoc. Director Regulatory Affairs
    MSD Oss
    David Jones
    BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist
    MHRA - Medicines & Healthcare Products, Regulatory Agency
    Ida Palsberg Hummelmose
    Global Senior Market Access Manager
    LEO PHARMA A/S
    Samuel David Ramsden
    Head of Risk Management Office
    Boehringer Ingelheim Pharma GmbH & Co. KG

    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