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stefansky

Prof. David Stepensky

Head of Pharmacy School and leading researcher in pharmacokinetics and drug delivery. Advisor to regulators and pharma innovators worldwide.
Areas of experties:
• Pharmacokinetics & Pharmacodynamics • PK–PD Modeling • Drug Delivery Systems • Preclinical & Clinical Development • Pharmaceutical R&D
ilan

Dr. Ilan Volovitz

Senior immunology researcher and FACS technology specialist. Advisor to biotech companies across the full product development lifecycle.
Areas of experties:
• Flow Cytometry (FACS) • Immunology and Cancer Research • Translational R&D • Biotechnology Product Development • Biomedical Research Strategy
mike

Mike Zaavi

Senior consultant in software validation and regulatory IT compliance. Expert in 21 CFR Part 11, Annex 11, and quality systems for biomedical software.
Areas of experties:
• Computerized Systems Validation (CSV) • Software Quality Assurance • 21 CFR Part 11 & Annex 11 • Regulatory IT Compliance • Biomedical and Clinical Systems
Ofer

Dr. Ofer S. Dubinsky, Ph.D.

Senior consultant and former pharmaceutical executive with deep QC and CMC expertise. Founder of Bio-Pharm Knowledge and long-standing industry lecturer.
Areas of experties:
• Pharmaceutical Quality Control • CMC & Analytical Sciences • Biotechnology Manufacturing • Regulatory Affairs & Due Diligence • Professional Training & Education

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Blog highlights

Software Validation in the Biomedical Industry – More Than Just a Regulatory Checkbox

Risk Management in Medical Devices – The Heart of Medical Device Safety

The Journey – How Pharmacokinetics (PK) and Pharmacodynamics (PD) Drive Drug Success

The Hidden Risk in Non-Sterile Drugs

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