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Course 1: PBRER


Instructors

  • Christina  Phan

    Christina Phan

    • Assoc. Director Safety Evaluation and Reporting, Worldwide Safety and Regulatory
    • Pfizer, Inc, United States

    Christina Phan has over 8 years of Drug Safety and Pharmacovigilance experience in the Pharma/Biotech industry at companies including Amylin Pharmaceuticals, Allergan, OSI Pharmaceuticals and currently at Pfizer as an Associate Director in Safety Evaluation and Reporting. Her experience includes coordinating and authoring aggregates reports including PBRER/PSURs, DSURs and PADERs, risk management/RMPs and case processing. Christina is a licensed pharmacist with a BS from University of California, Irvine and a Doctor of Pharmacy from the University of Southern California.

  • Valerie E. Simmons, MD, FFPM

    Valerie E. Simmons, MD, FFPM

    • EU QPPV, Global Patient Safety
    • Eli Lilly and Company Ltd, United Kingdom

    Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

  • Alison  Turney, PharmD

    Alison Turney, PharmD

    • Surveillance Business Process Advisor, Global Patient Safety
    • Eli Lilly and Company, United States

    Dr. Turney is a Surveillance Business Process Advisor in Global Patient Safety (GPS) at Eli Lilly and Company. She is responsible for coordination of activities and processes within GPS and between GPS and global and local functions within the company to maintain compliance with regulatory requirements worldwide. Alison has over 14 years of experience in Pharmacovigilance and is responsible for the strategy and development of processes to enable appropriate characterization and communication of the benefit risk balance of products for patients including Safety Surveillance, the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER).

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Other Preconference Short Courses

Pharmacovigilance and Risk Management Planning

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

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


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Pharmacovigilance and Risk Management Strategies Conference