Marco Barra Email & Phone Number

Italy

Consultant in Pharmaceutical Field:- Project Management- Data Integrity- Computer Systems Validation (CSV) &Computer Software Assurance (CSA) in GxP Regulated Environment- GAMP, 21 CFR Part 11, EU Annex 11- Documentation Production for Verification Process in V-Model Life-Cycle- Testing and Reporting- GxP Assessments- GxP Critical Systems- Standard Operating Procedures- Laboratory Systems- Production Systems- Serialization Projects- Manufacturing Execution System (MES)- Distributed Control System (DCS)- Electronic Batch Record System (EBR)- Quality Assurance (QA)

Utrecht, Paesi Bassi

Research at "Institute for Risk Assessment Sciences" (IRAS) involved in "MIP-DILI Project", in order to develop pre-clinical and clinical trials for idiosyncratic drug induced liver injury reactions.Title: "Trovafloxacin and drug induced liver injury: the role of NF-kB"Drug-induced liver injury (DILI) is an important reason for market withdrawal, representing a major problem for pharmaceutical company and healthcare systems. After an high incidence of severe hepatic adverse events, the fluoroquinolone trovafloxacin (TVX) was withdrawn from market. Further investigations revealed that TVX synergistically interacts with tumor necrosis factor (TNF) in vivo and in vitro, respectively causing severe liver damage and hepatocyte apoptosis. It has been shown that TVX/TNF combination induced hepatocyte apoptosis via replication stress in HepG2 cells. It is well known that both DNA damage response and TNF receptor activation initiate the cascades of two intracellular pathways: NF-kB and MAPKs. We tried to clarify the mechanisms involved in TVX/TNF-induced apoptosis focusing on the kinetics of NF-kB, MAPKs activation.Under the supervision of dr. Raymond Pieters and dr. Giulio Giustarini

Qualifying Examination For The Membership In The Order Of Pharmacists

Master Of Science (M. Sc.), Pharmaceutical Chemistry And Technology