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Friday, June 18 • 12:00pm - 1:00pm
#516 OD: Aggregated Clinical Safety Evaluation Utilizing Real-World Data and Randomized Clinical Trial for Safety Decision Making

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Component Type: Session
Level: Intermediate

Aggregated clinical safety evaluation is a continual and iterative process. Well-designed observational study and advanced statistical analysis in integrating randomized clinical trials (RCTs) and real-world data (RWD) can be used to answer regulatory safety question, both pre- and post- marketing.

Learning Objectives

Describe the potential role for randomized clinical trials (RCTs) and real-world data (RWD) in safety decision-making; Discuss the opportunities and challenges in aggregated clinical safety evaluation with both real world and clinical trial data sources.


Li-An Lin, PhD


Industry Perspective
Ranjeeta Sinvhal, MD

Integrative Analysis of Randomized Clinical Trial and Real-World Study
Li-An Lin, PhD

Advanced Machine Learning Methods for Casual Inference
Birol Emir, PhD

Walter Straus, DrMed, MD, MPH, FACP

avatar for Walter Straus

Walter Straus

Vice President, Safety and PV, Moderna, United States
Dr. Straus’ team oversees global clinical safety for investigational products as well as post-licensure safety monitoring and assessment for the Merck portfolio in vaccines and infectious disease therapeutics. He is trained as an internist, gastroenterologist, and epidemiologist... Read More →

Ranjeeta Sinvhal

Group Medical Director, Medical Safety Evaluation, AbbVie, United States
Have extensive experience in both post-marketing and clinical trials in pharmacovigilance for 15 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Intimate knowledge of processes and regulations in ICSR, aggregate reporting and signal... Read More →

Li-An Lin

Associate Principal Biostatistician, Merck & Co., Inc., United States
Li-An Lin is associate principal biostatistician supporting late stage oncology and general medicine therapeutic areas at Merck. Prior to Merck, he received a PhD degree in biostatistics from The University of Texas at Houston. Dr. Lin’s research areas include safety signal detection... Read More →

Birol Emir

Adjunct Professor, Columbia University; Senior Director, Pfizer Inc, United States
Birol Emir, PhD, is Senior Director and RWE Statistics Group Lead in the Statistical Research and Data Science Center at Pfizer Inc. In addition, he is a lecturer at Columbia University in New York and External PhD Committee Member at Rutgers University. Recently, his primary focuses... Read More →

Friday June 18, 2021 12:00pm - 1:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Session |   11: Statistics, Session |   20: Early Access Content, Session