This meeting will focus on paediatric requirements in the US and EU, with time for a Q&A session and roundtable discussion.
Please note that this meeting will be in-person only and not held as a webinar. Light refreshments will be provided.
Speakers
Jo Dewhurst, Director, Centre for Paediatrics Clinical Development - ICON
The Centre for Paediatric Clinical Development (CPCD) is a fully dedicated team of paediatric experts at ICON created to address the complex needs of paediatric drug development. We support ICON and our clients working with paediatric participants, including pregnant and lactating women, neonates, children, adolescents and young adults.
Ross Davidson is an Associate Director, Regulatory Submission - Medpace and has 17 years regulatory experience gained in CRO/Pharma. Ross currently leads and oversees various sub teams at Medpace and has interest in continual improvement of clinical trial applications that include paediatric subjects.
Agenda
Under the August 2017 Research to Accelerate Cures and Equity (RACE) for Children Act, amendments were made to the FD&C requiring pediatric investigations of new cancer drugs with molecular targets, if those targets were found to be of relevance to the pediatric population. This had broad implications, extending the need for PSPs to drugs that previously would have been eligible for a Waiver, including drugs for orphan conditions in the adult population. Given the implications of these changes to drug developers, the next TOPRA in Scotland Session will focus on these changes and their relevance to developers.
Extending the theme, in the second part of the meeting the TOPRA in Scotland group will reflect on lessons learned on managing paediatric clinical trial applications and the unique concerns surround paediatric clinical development. Finally, the meeting will conclude with a round table discussion where the Steering Committee will seek input on planning for 2025; we will welcome all TOPRA Members in Scotland to come along and actively contribute to the future of the organisation in Scotland.
Pricing
TOPRA Members: Free
Non-member: £45.00
How to register
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