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Amer Alghabban

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Bristol Myers Squibb
Amer Alghabban

R&D Quality Regulatory Authority Inspection Management at Bristol Myers Squibb

  Uxbridge, England, United Kingdom

About me

Amer is a GxP QA leader with 35+ yrs exp. spanning R&D QA, compliance, Clin R&D & PV. Currently, his role is R&D Regulatory Authority Inspection Management at BMS. Across his career, Amer managed & hosted >180 inspections. Prev. roles include: VP GxP QA, Compliance & Training at Karyopharm, executive quality leadership roles at Merck Serono & Arpida. He was former MHRA PV Compliance Officer & Assistant Editor of 11 medical journals. He's the author of Ref books in Pharmaceutical Medicines & Pharmacovigilance & peer reviewed articles. Invited Speaker at over 200+ conferences & universities. Passionate Trainer & AI Enthusiast

Schedule

My Session

Building Inspection-Ready Pharmacovigilance Systems: From GVP Compliance to Regulatory Authority Confidence

A Regulatory Authority and Sponsor-Side Perspective on Pre-Inspection Preparation, During-Inspection Excellence, and Post-Inspection CAPA Management

  • Understand what regulatory authorities specifically assess during routine PV inspections—moving beyond generic compliance checklists to inspector-led operational scrutiny
  • Apply the Six Pillars framework (PSMF Governance, Data Integrity, Signal Detection Robustness, Case Processing Quality, Vendor Oversight, Safety Committee Governance) to conduct self-assessment and identify gaps
  • Master pre-inspection preparation strategies, including mock inspection scenarios, staff coaching, and evidence compilation
  • Develop post-inspection CAPA management protocols anchored in ICH Q9 risk-based root cause analysis and regulatory citation closure

Amer Alghabban

R&D Quality Regulatory Authority Inspection Management at Bristol Myers Squibb

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