When: 12-14 May 2025
Where: TOPRA Office, 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN, UK
Day 1 start time: TBC | Day 3 end time: TBC

Also available as a virtual course, please click here for the registration option

Course overview

This course is designed for regulatory affairs professionals to develop and deepen their understanding of all aspects of EU Paediatric regulations. It will allow them to examine the regulatory requirements imposed on drug development, the processes of preparing regulatory documentation for clinical trial authorisation and marketing authorisation.

Benefits for delegates

This course will enable you to:

• Demonstrate the ability to critically analyse the legal documentation of the EU Paediatric Regulation and relevant guidelines.
• Select and adapt appropriate advanced problem-solving strategies for complex issues related to fulfilling the regulatory obligations of the EU Paediatric Regulation and obtaining regulatory approvals of paediatric clinical trials.
• Appraise and evaluate critically, research articles and scientific communications from a range of diverse sources including regulatory bodies.
• Analyse and evaluate incomplete and/or contradictory data and evidence both critically and systematically, to communicate conclusions and recommendations clearly to specialist and non-specialist audiences.

To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

Module Leader

Presenters

Suitable for

• Students of the TOPRA MSc programme
• Delegates from the pharmaceutical industry who wish to develop their knowledge
• Delegates from allied industries who wish to have a comprehensive understanding of the subject

Pricing

Type
TOPRA MSc Student: £1650 plus VAT*
TOPRA Member: £1900 plus VAT*
Non Member: £2100 plus VAT*

* VAT, if applicable, is charged at the rate of 20%   

Discounted place

• Those working for regulatory agencies, government agencies or academic institutions receive 25% discount.
• Those working for charities, patient groups or in full-time education receive 50% discount.

A limited number of discounted places are available at the rates below. Please note that discounted places are not valid for those enrolled on the MSc course.
Please email us at meetings@topra.org for a discount code before making your booking.

Terms and conditions

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