Profile: Over 31 years’ experience within pre-clinical, clinical R&D & pharmacovigilance (PV) operations helping biotech & pharmaceutical companies worldwide achieve compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Vigilance Practice (GVP), Good Distribution Practice (GDP) & Quality Assurance (QA). Over 21 years’ experience of conducting audits & investigations most of the world geographies (EU, USA, Canada, Eastern Europe, Middle East, North Africa, Asia (Japan, India, China, Malaysia, Singapore, etc.), Australia & Latin America & within disciplines governed by GCP, GVP, GCLP, GDP & GLP of: Investigator Sites, Clinical Central Labs., Clinical Research Organizations (CROs), other vendors (e.g. Clinical Supplies, & Distribution Depots, etc.), Corporate audits, Due Diligence of Business Partners & any acquired companies, Essential Clinical Documents, Clinical & Safety Databases, Pharmacovigilance System/Process/Vendors, Pharma Company Affiliates, HQ operations, & GLP Facilities. Can audit in any country. . Languages spoken: English (native), German (conversational), French (conversational), Persian/Farsi (Conversational) and Arabic (Fluent). Based in United Kingdom.
© Copyright 2023. All Rights Reserved.