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Tuesday, June 20 • 10:30am - 11:45am
#219: Safety Evaluation: Transforming Information into Evidence

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

Safety evaluation is a continuous process taking place throughout the life cycle of a medical product. Safety concerns have often been the primary driver in stopping or delaying development for many drug candidates. The lack of necessary safety data can compromise the regulatory acceptance of a program or a decision on a drug reimbursement. What are the different sources of safety data? How can one gather the necessary safety information without adding too much to drug development cost and without delaying the process of taking the effective medicine to a patient? In this session, presenters will review different sources of safety data and present medical considerations and statistical strategies of looking at pre-marketing stage of drug development, post-marketing safety surveillance, and other sources of real world data, and discuss how to use the totality of information to generate evidence for regulators, payers, physicians, and patients.

Learning Objectives

Identify different sources of safety data; Discuss how to use the totality of information to generate evidence.


Olga V Marchenko, PhD, MS


Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
Richard C. Zink, PhD

Traditional Sources of Pharmacovigilance Data and How Social Media Listening Has Been Used as a Complementary Data Source
Lorrie Schifano, PharmD

Transforming Data into Evidence
Olga V Marchenko, PhD, MS

avatar for Olga Marchenko

Olga Marchenko

Vice President, Advisory Analytics, QuintilesIMS
Olga Marchenko is Vice President at QuintilesIMS. She is a head of Advisory Analytics at QuintilesIMS Consulting Unit. A leading expert working on adaptive designs and safety, she provides strategic leadership for design and analysis of clinical trials. Dr. Marchenko received her... Read More →

avatar for Lorrie Schifano

Lorrie Schifano

Director, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline
Lorrie is Director, Safety Evaluation and Risk Management at GSK. She has more than 16 years experience in the pharmaceutical industry. Dr. Schifano obtained a B.S. in Pharmacy at Duquesne University in Pittsburgh, PA and her Pharm.D. at University of North Carolina, Chapel Hill... Read More →
avatar for Richard Zink

Richard Zink

Adjunct Assistant Professor, University of North Carolina at Chapel Hill
Richard C. Zink is Principal Research Statistician Developer in the JMP Life Sciences division at SAS Institute. Prior to SAS, he spent eight years in the pharmaceutical industry. He is the 2018 Chair-Elect for the Biopharmaceutical Section of the American Statistical Association... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session