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Mandarin Oriental Washington D.C.

Jan 22, 2017 10:00 AM - Jan 22, 2017 5:00 PM

1330 Maryland Avenue, SW, Washington, DC 20024

Short Course 2: ICH E2C(R2): The Quantum Leap from PSURs to Benefit-Risk Evaluation

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

Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom

Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety 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 focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

Alison  Turney, PharmD

Alison Turney, PharmD

Sr. Director, Global Patient Safety (GPS) Signal Management Process Owner, Eli Lilly and Company, United States

Alison Turney, PharmD 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 15 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 Post-Marketing Safety Surveillance, the Development Safety Update Report (DSUR) and the Periodic Benefit Risk Evaluation Report (PBRER).

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