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Live, Intensive Online Courses by Top Global Experts
Practical, certified, and ROI focused learning in Quality, Regulation & Clinical
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Pharmacokinetic and Pharmacodynamic (PK/PD) Analysis in Drug Development
A practical introduction to pharmacokinetic and pharmacodynamic (PK/PD) analysis in drug development, covering PK processes, exposure-response relationships, and modeling approaches used in preclinical and clinical studies.
Ideal for professionals working in drug development, clinical research, regulatory affairs, and pharmacology.
Course Date: 24/04/2026
Outsourced Operations: Using Contract Facilities
A practical training on managing outsourced pharmaceutical operations, including CDMOs, contract laboratories, quality agreements, contractor oversight, and regulatory expectations from FDA, EMA, and EU GMP.
Ideal for professionals responsible for outsourcing, quality systems, regulatory compliance, and contractor management.
Course Date: 24/04/2026
Microbial Control Strategy: Managing Risks in Non-Sterile Manufacturing
A practical training on designing microbial control strategies for non-sterile pharmaceutical manufacturing, including environmental monitoring, water system oversight, microbial limits testing, and regulatory expectations from FDA and USP <1111>.
Ideal for professionals in quality, microbiology, manufacturing, and regulatory compliance.
Course Date: 24/04/2026
Computerised Systems & Artificial Intelligence (AI) in GMP
A practical regulatory course covering AI, computerized systems, and upcoming GMP updates including FDA / EMA guidance, Annex 11, and the new Annex 22.
Designed for pharmaceutical professionals who need to understand AI governance, data integrity, digital systems validation, and regulatory expectations for AI adoption in GMP environments.
Course Date: 24/04/2026
Medical Device Risk Management (ISO 14971)
Master practical risk management for medical devices.
This intensive live course teaches professionals how to implement ISO 14971:2019 risk management processes, maintain compliant Risk Management Files, and align development activities with EU MDR and global regulatory expectations.
Ideal for R&D, QA, Regulatory Affairs, and medical device development teams.
Course Date: 24/04/2026
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Prof. David Stepensky
• Pharmacokinetics & Pharmacodynamics • PK–PD Modeling • Drug Delivery Systems • Preclinical & Clinical Development • Pharmaceutical R&D
Dr. Ilan Volovitz
• Flow Cytometry (FACS) • Immunology and Cancer Research • Translational R&D • Biotechnology Product Development • Biomedical Research Strategy
Mike Zaavi
• Computerized Systems Validation (CSV) • Software Quality Assurance • 21 CFR Part 11 & Annex 11 • Regulatory IT Compliance • Biomedical and Clinical Systems
Dr. Ofer S. Dubinsky, Ph.D.
• Pharmaceutical Quality Control • CMC & Analytical Sciences • Biotechnology Manufacturing • Regulatory Affairs & Due Diligence • Professional Training & Education
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