Stefania Ragone PhD

Stefania is a regulatory professional with expertise in CMC and regulatory strategy. As the EMA Quality Rapporteur for the Drug/Device Combination (DDC) guideline until March 2018 and as a member of the Cross-Agency working group for DDC products she has developed specialist knowledge in DDC products. She has extensive knowledge of enteral feeding tube (EFT) administration as co-coordinator of the internal MHRA enteral feeding tube group and member of the quality working for the party on minimum data required for the authorization of medicines administered via enteral tubes until March 2018.

As a Senior Pharmaceutical Assessor at the MHRA, she is responsible for critically evaluating the CMC aspects of marketing authorization applications and variations, submitted via Centralised, Decentralised, Mutual Recognition, and National procedures for central nervous system products including nicotine addiction (e-cigarette and transdermal system) products. She also provides regulatory and strategic input into CMC development plans in pre-submission scientific advice meetings, SAWP, and national scientific advice meetings.

Stefania holds a Ph.D. in biochemistry specialized in crystallography from Universita’ Degli Studi di Torino, Italy, for research conducted at and in collaboration with Cambridge University, UK. She is a registered UK Pharmacist since 2007. Prior to her Ph.D., Stefania worked as a Pharmacy Manager in a registered pharmacy for preparing unlicensed medicines in Milan, Italy.