Regulatory Challenges in Paediatric Research

29th July: Regulatory Challenges in Paediatric Research

Speakers

Viviana Guiannuzzi

Viviana is PharmD and PhD in Cellular Biochemistry and Pharmacology and coordinates the Research & Innovation Department of Fondazione per la Ricerca Farmacologica Gianni Benzi – ETS. She is also a member of the Paediatric Committee of the European Medicines Agency (EMA) and Vice-Chair of EPTRI.

 

 

 

 

Breda Kearney

Breda is Clinical Regulatory Lead at BSI, with expertise in medical device regulation, clinical evaluation and regulatory strategy. She has extensive experience supporting manufacturers in meeting international regulatory requirements and is involved in Team-NB activities related to clinical and post-market surveillance.

Marc Dooms

Marc Dooms is Senior Orphan Drug and Medical Device Pharmacist at University Hospitals Leuven, with extensive experience in clinical trials, rare diseases, innovative therapies and clinical pharmacy. He has contributed to several international scientific networks and has authored more than 100 peer-reviewed publications. He is actively involved in European initiatives supporting the development and translation of innovative therapies, including TRANSFORM.