Pfizer Global Regulatory Operations, Belgium
Gabriella (Gaby) Di Matteo is currently the Director and Team Lead in Pfizer Clinical Trial Regulatory Operations (CTRO), where she leads a team of Clinical Trial Submissions Managers responsible for submitting clinical trials in Europe, Africa, and the Middle East. Within EFPIA, she is a member of the CTIS SME group led by EMA, which includes sponsors and member states CTIS SMEs as well as being part of the cross-industry team on EU CTR and CTIS. Gaby is also part of the COMBINE workstream for EFPIA as a CTIS SME, driving the implementation of COMBINE in CTRO and Pfizer.
She is a member of the EFPIA CT Reg Pillar group and an ad-hoc participant of the EFPIA CREG and Transparency groups. Gaby has participated in the ACT EU ICH E6 (R3) workshop organized by EMA. She has been involved in the European regulatory evolution from pre-CTD to CTR and CTIS implementation, being a member of the Pfizer workstreams implementing EU CTR and a tester of CTIS since UAT 1 in early 2016. EUDAMED testing is the next step in relation to the COMBINE project.
Gabry Di Matteo has over 30 years of experience in Early Clinical Research and Regulatory submissions, having spent many years in the Pfizer Phase 1 Clinical Research Unit from its inception until CRU managing increasingly complex studies.
