Designed for regulatory affairs professionals, this course covers key requirements for clinical trials and marketing authorisation, equipping you with the knowledge to navigate compliance with confidence.
By attending this training course between 12-14 April 2025 (in-person in London, UK or online), you will be able 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
✅ Earn 19 CPD hours
This course is part of our range of Masterclasses and is Module 23 in our MSc programme. Our Masterclasses are developed and delivered by a faculty of expert speakers and validated by the University of Hertfordshire.
Discounted rates are available for TOPRA MSc students, those working for regulatory or government agencies, academic institutions, charities, patient groups, or in full-time education.
