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Mandarin Oriental Washington D.C.

Jan 22, 2017 1:30 PM - Jan 22, 2017 5:00 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Short Course 4: FDA Pharmacovigilance Inspection Readiness

Instructors

Shiferaw  Kibriye, PharmD

Shiferaw Kibriye, PharmD

Medical Quality Assurance. Head of Inspection Management and GLP QA, 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.

LaShanda  Long, MS

LaShanda Long, MS

Supervisor, Office of Scientific Investigations, OC, CDER , FDA, United States

LaShanda Long is the branch chief of the Postmarketing Safety Branch (PSB) in the Office of Scientific Investigations, CDER, FDA. PSB monitors adherence to regulations and statutes governing postmarketing adverse drug experience reporting requirements, Risk Evaluation and Mitigation Strategies, and postmarketing requirements. LaShanda earned a BS in biology from Howard University, a MS in biotechnology from Johns Hopkins University and her US Regulatory Affairs Certification.

Representative Invited

Representative Invited

FDA, United States

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