When: 12-14 May 2025
Where: Online
Day 1 start time: TBC| Day 3 end time: TBC
Also available as a face to face course, please click here to register for the face to face 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.
CPD: This course provides 15 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Programme
Download a copy of the draft agenda here.
Module Leader
Module Leader for this Masterclass to be confirmed.
Presenters
Speakers for this Masterclass to be confirmed.
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 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.