Beat Widler

Basel Area, Switzerland Switzerland

Managing Partner

Medical / Health Care / Pharmaceuticals

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 Nursi...