The EU Paediatric Regulation

The EU Paediatric Regulation
This Masterclass will enable delegates to understand the legislative framework and practical aspects of the EU Paediatric Regulation and considerations around designing paediatric clinical trials.


When: 12-14 May 2025
Where: Lincoln Plaza London Hotel, 2 Lincoln Plaza, Canary Wharf, London, E14 9BD
Day 1 start time: 12:30 | Day 3 end time: 16:30 BST

This course is also available to attend online.

Suitable for

This course is essential for:

  • 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
  • Students on the TOPRA MSc programme.

Note: this course is also Module 23 of the MSc Regulatory Affairs.

Course information

This course is designed for regulatory affairs professionals to develop 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 critically evaluate 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.
  • Develop a detailed understanding of the Paediatric Investigation Plan (PIP) including waivers, the content of a PIP, and interactions with regulatory bodies.
CPD: This course provides 19 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

You can view and download the course programme here.

Module Leader

     Evgenia Mengou FTOPRA, Owner, EV Pharma Solutions Ltd

Presenters

Presenters for this training course include:                        

  • Michelle Blake MTOPRA, Associate Director and Senior Regulatory Consultant, DLRC Regulatory Consultancy
  • Harris Dalrymple, Camden and King’s Cross Research Ethics Committee
  • David Jones MTOPRA, BSc, MSc, EurBiol, CBiol, FRSB, ERT, FBTS, Experienced Regulatory Affairs Professional
  • Christian Maasch, Head Product Quality & Regulatory Affairs CMC Compliance/LCM and Change Control Management, Takeda 
  • Dr. Martine Dehlinger-Kremer MTOPRA, Vice President Scientific Affairs, Pediatric SME at ICON Plc and President & Chair of the Paediatric WG at EUCROF
  • Steve Pinder, Owner, Envestia Ltd
  • Angeliki Siapkara, Senior Director Regulatory Affairs, AstraZeneca
  • Harriet Gray Stephens, Medical Director, Boyds
  • Mette Due Theilade Thomsen, Owner, PIP Adviser
  • Dominik Karres, Scientific Officer, EMA
  • Paula Muñiz, Senior Director Model Informed Development, CTI Clinical Trial and Consulting Services
  • Monica Rodriguez, Managing Director, Global Laboratory, Pharmacometrics & Site Services, CTI Clinical Trial and Consulting Services

Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member		 £1,900.00 + VAT*
 Standard Price
 Non-member		 £2,375.00 + VAT* 
 TOPRA MSc Students
  		 £1,650.00 + VAT*

Save on the full cost of membership and £180 on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
 
 Discounted training course registration fees
 Event Registration Type Price (GBP)
 Government or academic rates
 TOPRA Member
 £1,425.00 + VAT*
 Government or academic rates 
 Non-member
 £1,781.25 + VAT*
 Charities, patient groups, full-time education rates
 TOPRA Member		 £950.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
  £1,187.50 + VAT*

Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
 

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

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

 
When
12/05/2025 - 14/05/2025
Where
Lincoln Plaza Hotel London E14 9BN UNITED KINGDOM
Sign in or create an account to register Last day to register is 12/05/2025
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