When: 12-14 May 2025
Where: TOPRA Office, 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: TBC | Day 3 end time: TBC
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 draft programme here.
Module Leader
Presenters
Presenters for this training course include:
- Melissa Blake
- Harris Dalrymple, Executive Director, Centre for Pediatric Clinical Development, ICON plc
- David Jones
- Christian Maasch, Head Product Quality & Regulatory Affairs CMC Compliance/LCM and Change Control Management, Takeda
- Steve Pinder, Owner, Envestia Ltd
- Harriet Gray Stephens, Medical Director, Boyds
- Mette Due Theilade Thomsen, Owner, PIP Adviser
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.