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Course 4: Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking


Instructors

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

    • Vice President, Pharmacovigilance Excellence and QPPV
    • AbbVie, Inc., United Kingdom

    Vicki Edwards qualified as a pharmacist and spent time in hospital pharmacy and community pharmacy before going GlaxoWellcome in 1995 to begin her career in pharmacovigilance – she began life as a case processor. She moved to AstraZeneca in 2000 as head of Safety and Medical Iformation at the UK marketing company and moved to Abbott as QPPV in 2005. When Abbott split into Abbott and AbbVie in 2013 Vicki became AbbVie QPPV and Head of Affiliate Vigilance Excellence. Today Vicki is Vice President, Pharmacovigilance Excellence and QPPV.

  • Shiferaw  Kibriye, PharmD

    Shiferaw Kibriye, PharmD

    • Medical Quality Assurance. Head of Inspection Management
    • Pfizer Inc., United States

    Shiferaw is currently the Head of Inspection Management, within Medical Quality Assurance at Pfizer. Previous to his current role, he was an Executive Director, Therapeutic Area Head within Safety Evaluation and Reporting within the Worldwide Safety organization at Pfizer. Previous to these roles, Shiferaw worked in the Global Investigator Initiated Research (IIR) group as a Director/Team Leader in charge of all IIRs in the Specialty Care and Emerging Markets Business Units.

  • Helen  Powell

    Helen Powell

    • Principal Consultant
    • NDA Regulatory Science Ltd, United Kingdom

    Helen Powell has over 30 years’ experience in the pharmaceutical industry in large pharma, CRO and consultancy sectors. She brings significant expertise in auditing (GCP, PV and auditing of corporate legal risks), has managed global audit teams across the USA, Asia Pacific and Europe, as well as facilitating PV and GCP inspections in these territories.