MARTIAL VERSCHOOT

Martial Verschoot

Key Responsibilities


In-House auditing clinical trials

Conducting Investigator Site Audits

Facilitation of Regulatory Inspections

(presence in front or backup room)

GCP Quality Assurance Training

Experience


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:

  • Rotterdam Hogeschool, The Netherlands; ESAME Foundation, Spain; University Limoge, France, BARQA (RQA), Masterclass, Cranfield University, UK; University of Antwerp, Belgium
  • During career, delivered QA presentations to BfArM, Italian, Romanian, Egyptian Regulators
  • Lead Auditor (Quintiles) at the EMA/FDA inspection(s) related to the Inspection Harmonization Initiative (presented conclusions at the Drug Information Association (DIA) meeting, Genève, Switzerland in presence of participating inspectors).
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