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Omni Shoreham Hotel

21 ene 2018 1:30 p.m. - 21 ene 2018 5:00 p.m.

2500 Calvert Street NW, , Washington, DC 20008 , USA

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

Instructors

Vicki  Edwards, RPh

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

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.

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, the majority of time in QA conducting audits in GCP, Pharmacovigilance and auditing of corporate legal risks. Prior to becoming an auditor, Helen worked in laboratory research, as a sales representative and a Clinical Research Associate. She has managed global audit teams across the USA, Asia Pacific and Europe, as well as facilitating Pharmacovigilance and GCP inspections in these territories.

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