KU RA M2: The EU Regulatory Environment - Procedures and Applications

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

7 Sep 2022
6 Sep 2023

3 days course

English

21,200 DKK ex VAT
(app. 2,850 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

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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.

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Course leader(s) & Lecturer(s)

  • Eva Maiken Holck
    Course leader
    Regulatory Affairs senior RA CMC specialist
    Nykode Therapeutics
  • Mette Due Theilade Thomsen
    Course leader
    Managing Director
    PIP Adviser
  • Hans Hoogland
    Lecturer
    Senior Regulatory 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
    German Federal Institute for Drugs and Medical Devices (BfArM)
  • 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
    Regulatory Consultant
    Zwiers Regulatory Consultancy BV
  • David Jones
    Lecturer
    BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
    UNKNOWN
  • 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 7 Sep 2022
Starting 6 Sep 2023
7 Sep 2022 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
8 Sep 2022 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
9 Sep 2022 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
10 Aug 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
7 - 9 Sep
6 Sep 2023 8:30-18:00

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
7 Sep 2023 8:30-18:00

DAY 2

  • Scientific Advice from CHMP and National Competent Authorities
  • Group Exercise
  • Post Approval Activities
  • Paediatrics – Procedural Perspective
  • Paediatrics – Case Story
  • Group Work
8 Sep 2023 8:30-16:30

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
9 Aug 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
6 - 8 Sep
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. 

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 senior RA CMC specialist
Nykode Therapeutics
Mette Due Theilade Thomsen
Managing Director
PIP Adviser

Lecturer(s)

Hans Hoogland
Senior Regulatory 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
German Federal Institute for Drugs and Medical Devices (BfArM)
David King
Senior Director of Regulatory Affairs at HealxStirling, Scotland, United Kingdom
Healx
Janina Karres
Scientific Officer
EMA - European Medicines Agency
Ingrid Prieschl
Regulatory Consultant
Zwiers Regulatory Consultancy BV
David Jones
BSc, MSc, EurBiol, CBiol, MIBiol, Registered Toxicologist, Independent consulting
UNKNOWN
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

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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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