(presence in front or backup room)
13 years experience End Stage Renal Disease (Head Male nurse Kliniek Zwarte Zusters).
Subsequent to University, 28 years’ QA experience in all therapeutic area’s (Bristol-Myers Squibb and Quintiles (IQVIA), mainly GCP (conducted amongst other 450+ Investigator Site Audits - ISA’s in most EU countries, Latin America and USA).
Executive Director within Quintiles (IQVIA’s) multinational QA Department (managed up to 30+ QA and 25+ Clinical Operations staff members).
Lead and participated in EMA and FDA inspections in Europe; in-house, on-site and Customer inspections, in total 40+ inspections, (majority Investigator site inspections, in- house and on-site), e.g.Belgium, France, Greece, Germany, Poland, Romania, Russia, The Netherlands, Switzerland, Ukraine; In addition, conducted two in-house audits in Japan, and on-site audits in Latin-America and USA). Lead two in-house Regulatory Inspections, (UK and US office inspection on Customer’s behalf).
During previous years teaching assignments as member of the faculty at: