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Course 3: Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs


Instructors

  • Richard  Abate, MS, RPh

    Richard Abate, MS, RPh

    • Lead Consumer Safety Officer
    • FDA, United States

    Richard Abate serves as the Postmarketing Adverse Drug Experience (PADE) Compliance Team Leader in CDER's Office of Compliance. Rick joined FDA in 2006 as a Safety Evaluator in CDER's Office of Surveillance and Epidemiology and moved to Office of Compliance in 2013. Rick obtained a BS in Pharmacy from the University of Maryland and a MS in Pharmacy Practice from the University of North Carolina.

  • Marcia  Gelber, PharmD, RPh

    Marcia Gelber, PharmD, RPh

    • Pharmacist
    • Food and Drug Administration, United States

  • 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.

  • Michael  Richardson, MD, FFPM

    Michael Richardson, MD, FFPM

    • International GPV&E and EU QPPV
    • Bristol-Myers Squibb, United Kingdom

    Currently International Head of BMS’s Pharmacovigilance Function and EU QPPV based in the UK. He is medically qualified graduating from Stellenbosch University and specialised in Obstetrics and Gynaecology. He practiced in Cambridge prior to joining the Pharmaceutical industry in Clinical Research and then Medical affairs. He has worked in major MNCs across the globe and heading up Research and Development in Asia. He is also a long serving member of the EFPIA PV committee, served on ICH E2C(R2) EWG and Q&A IWG. Additionally Heads BMS Global Risk Management function.