Christophe Barcella

Oversaw and coordinated global QA (GCP) and regulatory affairs across Montreal, Edmonton and Paris offices

Organized quality management and regulatory affairs department including supervision, budget planning, resource allocation, training and project planning

Developed BCIRG SOP management system and designed company processes

Managed and conducted worldwide audits of processes, study files, investigator sites, electronic systems, central labs and subcontractors

Provided regulatory support for five phase III studies in chemotherapy and hormone therapy across 35 countries

Coordinated regulatory document review and approval and acted as regulatory intelligence with agencies

Reviewed internal validation plans for web-based registration/randomization and remote data capture systems

Drafted, reviewed and approved all SOPs including quality management, clinical monitoring, randomization, safety, data management, medical writing and regulatory affairs

Coordinated five global clinical trial applications including IND, annual reports and PSUR

Conducted benchmarking for CRO selection and set up investigator compliance database

Performed CSV audits of EDC, pharmacovigilance and site monitoring systems

Conducted multiple training sessions on global GCP, BCIRG SOPs, informed consent, Canadian regulations, FDA financial disclosure, ERES, regulatory inspections and quality management program

Supervised QA/QC unit of five staff

Established regulatory compliance programs under cGMP, GLP and GCP

Conducted audits of ongoing clinical studies including TMF, investigator sites, ethics committees, laboratories and CROs

Organized regulatory affairs department and coordinated submissions to FDA CDER and Health Canada TPD

Participated in preparation and approval of validation master plan for production and QC testing

Implemented operational quality plans in clinical research, regulatory affairs and quality unit

Deployed environmental monitoring program for non-sterile production

Prepared three pre-IND meeting packages and various FDA and TPD submissions including investigator’s brochure, annual IND reports, safety reports, CMC, DMF and protocol amendments

Performed cGMP audits in sterile and non-sterile production

Investigated microbiological contamination events and proposed cGMP-compliant solutions

Controlled quality of in-process and finished products and planned laboratory stability tests

Conducted potency assays and microbiological controls including sterility, pathogen detection, total counts and pyrogen testing

Managed batch documentation and delivered cGMP training for sterile production staff