More than 100 audits worldwide (e.g. in Europe, Eastern Europe, US, Latin-American, Japan, Australia and China) as lead or co-auditor covering clinical trial center audits, system audits (e.g. as lead auditor laboratories, “drug supplies”, monitoring systems, archiving, CROs, safety systems, study reports, IRBs / IECs, pre-inspections and inspections by FDA, MHLW and local inspectorates; as co-auditor data management, CSV and informatics audits). Interactions with EMEA, FDA, Swissmedic, MHLW with regard to QA aspects of submissions.
As a member of the international assessment board participation at the request of the Dean of the University in the evaluation of the Faculty of Nursing Sciences of the University of Basel (2003).
Trainer of WHO monitors and auditors in GCP and GCP auditing matters and leader of an assessment of FERCAP in Bangkok (2010).
Initiated and leading the Roche Pharma Clinical Quality Risk Management (C-QRM) project first in collaboration with WCI and now with Booz & Company. C-QRM applies principles of 6-Sigma and FMEA to clinical development activities and pharmacovigilance to build processes allowing early detection of critical errors and implementation of corrective and preventive actions.
Specialties: In-depth quality, quality risk management and GCP experience