This course will no longer be available to access. 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.
This online course consists of 3 modules, each one taking around one hour to complete. All modules are supported by additional resources and include interactive exercises to reinforce what you have learnt.
Why you should take this course
- It will enable you to successfully negotiate the pitfalls and complications of the paediatric regulation
- It will equip you with the knowledge you need to advise your project teams on the right steps to take
- It is interactive, enjoyable and easy to follow
- You can complete it at your own pace
- You will have access to a large library of resouces for a whole year
- It will allow you to learn from your peers as well as the course authors through comments from participants
Who should take this course?
- Regulatory professionals who want to gain an understanding of the EU Paediatric Regulation
- Individuals that have limited experience in the area, but have been working in a different area of regulatory affairs for a number of years
On completion of the course, you will be able to understand the background to the paediatric regulation; why and how it came into being, its significance and impact and what a regulatory professional needs to know.
Module overview
| Module 1: Background to the European Paediatrics Regulation |
Module 2: Developing a PIP |
Module 3: Working with a PIP and other considerations |
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This introductory module will help you understand the background of the regulation
- Why the paediatric 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
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This module will give you a detailed understanding of the Paediatric Investigation Plan (PIP), including waivers, the content of a PIP, how a PIP is put together and interactions with regulators
- What is PIP?
- What stages are involved in the PIP process?
- What is the content of a PIP?
- Who writes the PIP?
- Who reviews the PIP?
- How does the PIP get agreed and how long does it take?
- What interactions can I have with the regulators? And when and how can I interact with them?
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This module will help you understand the considerations around designing paediatric trials
- What happens if we do not have a PIP?
- How can I prove compliance?
- When and how do we need to modify the PIP?
- What are the incentives?
- What if I have or need multiple PIPs?
- What are the considerations when designing clinical trials for paediatrics?
- What else is there in paediatric regulation I need to know about?
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Course authors
Our two course authors have a wealth of experience in regulatory affairs and both play key roles in the implementation of the Paediatrics Regulation
- Azzurra Ravizza - Director - Worldwide Regulatory Strategy, Pfizer, UK
- Joanne Phipps - Senior Regulatory Programme Manager, Roche Pharmaceuticals, UK
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.
If the course is not accessed within 12 months of purchase, the course access will expire and you will not be entitled to a refund.
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 3 hours to complete, you will therefore receive 3 CPD hours upon completion.
How to register
- Sign into this website, or create an account
- Click 'Register myself'
- Go to your basket and pay for the course
- TOPRA will email you full instructions
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 fee
Registation fee: £415+VAT
All fees are shown in Pounds Sterling and do not include VAT
If you have already registered for Module 1 and you would now like to complete modules 2 and 3 please contact meetings@topra.org for a discount code.