Biography

Amer Alghabban has over 27 years track record in the pharmaceutical industry GxP (GCP, GVP, GCLP, GLP & GDP) QA. He has presented & chaired at over 110 international Congresses, Universities & WHO. He was the Assistant Editor for 11 Medical & Pharmaceutical journals. He is the sole author for 2 books “The Pharmaceutical Medicine Dictionary” in Apr01, “The Dictionary of Pharmacovigilance” May04 & currently writing 3rd book, Dictionary of Clinical & Pharmaceutical Development. He has managed & hosted over 66 Regulatory Authority (RA) inspections & inspection readiness projects. He has over 16 yrs GxP auditing experience of clinical services providers (CROs, Pharmacovigilance), Business Partners/Due Diligence, Investigator Sites, Clinical Central (& specialist labs e.g. Biomarkers) Labs (GCLP), Vendors (ECG, MRI, DM, etc), EC/IRBs, Mock Inspections, Essential Documents (Protocol & Amendments, ICF, CSR/CTR, Submission Dossier, etc), Clinical & Safety Database Audits, PhV System/ Process/ Vendors, Pharma Company Affiliates, HQ operations, GMP sites, GLP Test Facilities compliance with applicable regulations.

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Research Interest

Biosimilars, GCP, GVP, GCLP, GLP & GDP