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Virtual

Nov 07, 2022 10:00 AM - Nov 07, 2022 2:30 PM

Short Course: How Good is Good Enough? Fit-for-Purpose Considerations for RWD/RWE for Regulatory Purposes

This is a Pre-Conference Short Course in conjunction with the Real-World Evidence Conference

Instructors

Representative Invited

Representative Invited

United States

Anna  Vlahiotis, MA

Anna Vlahiotis, MA

Director, Oncology/Precision Medicine RWE Scientist, RWE Center of Excellence, Pfizer, United States

Anna is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where she designs RWE strategy and works with teams across the drug development lifecycle to generate RWE in support of organizational decision making and regulatory engagement. Anna has more than 15 years’ experience utilizing real-world and clinical data to conduct healthcare research. Her prior work includes leading study teams in the design and implementation of outcomes research studies in the payer space, and on behalf of pharmaceutical and medical device companies in support of regulatory submission and post-marketing commitment. Over the course of her career, Anna has published extensively, and won the AMCP Award for Research Excellence.

Jonathan  Assayag, DrSc, PhD, MSc

Jonathan Assayag, DrSc, PhD, MSc

Director, RWE Scientist Oncology, RWE Platform, Pfizer, Canada

Jonathan is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where he designs and executes on RWE strategy and works with teams across the drug development lifecycle. Jonathan has more than 10 years’ experience utilizing real-world and clinical data to conduct and communicate healthcare research. His prior work includes working in medical affairs where he also led RWE education initiatives for Pfizer colleagues. Jonathan holds a PhD from McGill University in Pharmacoepidemiology where he is also currently an instructor in the department of Medicine.

Jaclyn  Bosco, PhD, MPH, FISPE

Jaclyn Bosco, PhD, MPH, FISPE

Vice President and Global Head of Epidemiology, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

Jillian Mae Rockland, MPH

Jillian Mae Rockland, MPH

Director, Regulatory Strategy, Flatiron Health, United States

Jillian Rockland leads Flatiron Health’s Regulatory Strategy team, which supports Flatiron Health’s life science partners in using RWD/E for regulatory decision-making. Previously, she oversaw Flatiron RWE product and operations, managing the scoping, creation and delivery of research-question specific real-world datasets to partners for regulatory use. Prior to joining Flatiron, Jillian managed clinical research teams in executing industry-sponsored, multi-site clinical trials and then led strategy and development for several healthcare technology products. Jillian received her undergraduate degree in Neuroscience from Northeastern University and her MPH in Epidemiology and Biostatistics from Columbia University.

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