Julia joined NDA in 2014, she is an expert in paediatric drug development, clinical development and marketing authorisation applications including orphan drugs.
Julia’s extensive experience provides vital direction & guidance to clients, in all phases of development from drug development to post-marketing.
Key Areas Of Expertise
- Extensive experience in regulatory affairs including:
- Assessment of paediatric investigation plans,
- Applications for orphan drug designations
- Assessment of significant benefit as part of orphan drug designation
- Clinical dossiers of marketing authorisation applications
- OTC switch assessments
- High stakes EU meetings
- Direct involvement in developing European legislation, including the Paediatric Regulation.
Before Joining The NDA Advisory Board
Julia was the former Head of Special Populations Unit, Medicines and Healthcare Regulatory Products Agency, UK; Paediatric Committee and Pharmacovigilance Risk Assessment Committee member, European Medicines Agency.
Secondments to both the Office of Paediatric Therapeutics, Food and Drug Administration, US, and to the Pharmaceuticals Unit, European Commission; Committee for Human Medicinal Products and Committee for Orphan Medicinal Products member, European Medicines Agency.
She was also the Chairman European Council Working Party on the Paediatric Regulation
(Regulations (EC) Nos 1901/2006 and 1902/2006); Rapporteur for European Guideline on Paediatric Pharmacovigilance; Management Board Member, UK Medicines for Children Research Network and EU rapporteur for ICH guideline on Paediatric Medicine Development
Julia Co-edited the Pediatric Drug Development 2nd edition and co-led FDA cross-divisional working group on extrapolation of efficacy from adults to the paediatric population; globalisation of paediatric clinical trials
Royal College of Physicians (London UK), Royal College of Paediatrics and Child Health (Honorary)
Dr Julia Dunne