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Thursday, April 8 • 11:00am - 11:30am
CASE STUDY: FIVE BIO-EQUIVALENCE STUDIES DURING COVID

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Health Authority Inspection Uncovered Critical Gaps in Quality and Forced Accelerated Re-Performance of Five Bioequivalence (BE) Studies During COVID 
  • Discuss background of study and inspection of previous In-Vivo BE studies for already established products
    • Gaps observed regarding efficacy and safety variables as well as data quality assurance
    • Lack of CRO oversight during original study
  • Understand the corrective action plan and GCP challenges related to having to redo the studies in an expedited nature and during COVID
  • Evaluate preventive action and lessons learned
Speakers
avatar for Ahmed Bashtar

Ahmed Bashtar

Quality Unit Lead, Dubai Hub, Middle East & Africa, BRISTOL-MYERS SQUIBB
Ahmed has ten years of experience in the pharmaceutical industry. He’sheld many posts in different fields e.g. R&D, quality control, quality assurance, Compliance auditing, supplier Quality Management, third parties Management, and supply chain management. He’s had experience... Read More →

Thursday April 8, 2021 11:00am - 11:30am EDT
  Presentation

Attendees (15)