Profile: GVP auditor with 8-year experience in PV operations & 5 years’ experience in audits. Lead auditor for all types of GVP audits. Support to global & local PV HA inspections. Expertise are GVP Audits: System, Affiliate, vendor, distributor, partner audits, GVP Health authority inspections support (MHRA, TGA, ANSM), European PV regulation, ICH, US, Canada, Switzerland regulations. Languages known: English - C1 (CEFR) French - native Spanish - B2 (CEFR) German - A2 (CEFR). Technical skills are Audit management tools: Veeva, Trackwise, Safety databases: Argus, Safety-easy, Computer System Validation, MedDRA dictionary. Based in Belgium.