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Omni Shoreham Hotel

2018年1月21日 (日) 午後 1:30 - 2018年1月21日 (日) 午後 5:00

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

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

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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