The EU Paediatrics Regulation: Module 1

The EU Paediatrics Regulation: Module 1
This course will no longer be available to access as the course content is currently being updated. A new course on Paediatrics Regulation will be made available in 2024. In case you are interested in the new course and would like to be added to the waiting list, please send us an email to meetings@topra.org. Module 1 of this new, unique online course, the only one available on this topic, will give you a comprehensive background to the Paediatric Regulation.


Why take this course?

The new online course will give you all the information you need on the Paediatric Regulation.

All regulatory professionals developing medicines for Europe need a good understanding of the Paediatric Regulation. A key part of the regulatory role lies in advising your project team in the right steps to take. This essential course, the first of its kind, will provide you with all the information you need.

The course consists of 3 modules, each one taking about an hour to complete and supported by additional resources containing a wealth of information. Interactive exercises and case studies are included to reinforce the learnings.

Who should take this course?

This introductory module is ideal for all regulatory professionals who want to gain an understanding of the EU Paediatric Regulation. You may be new to regulatory affairs, or may have been working in a differ you may have been working in another area of regulatory affairs for a number of years.

Module 1: Background to the European Paediatrics Regulation


This introductory module will help you understand the background of the regulation:

  • Why the paediatrics regulation is important, how it came about and the impact it has had
  • The key stakeholders and regulators involved 
  • where to go for guidance 
  • An introduction to the PIP: When, who and how
  • Paediatric requirements outside the EU

Further information

Modules 2 and 3 are available to book. If you have purchased module 1 you will receive a discounted price for modules 2 and 3.

Frequently asked questions
How long will the course take?
You have 365 days access to this course, during this time you can complete the course at your own pace. You can exit the course at any point and all of your answers will have been automatically saved.

What do I have to do to complete the course?
To complete the course you must go through each topic and answer a selection of questions. Once you have completed the course you will receive a completion certificate.

How many CPD hours will I receive?
We recommend that this course should take you 1 hour to complete, you will therefore receive 1 CPD hour upon completion. 

Please read the training terms and conditions before booking onto this course. By booking a place on this course you are agreeing to the training terms and conditions.

Course price
Module 1 registration fee: £250+VAT
All fees are shown in Pounds Sterling and do not include VAT

 

How to register

  1. Sign into this website, or create an account 
  2. Click 'Register myself'
  3. Go to your basket and pay for the course
  4. TOPRA will email you full instructions
Where
Can Be Taken on Any Date Online Paediatrics
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