Biopharmaceuticals (includes Biologics)
Applied
Daryl Spinner, PhD
Managing Director, Real-World Value & Strategy; Precision & Transformative Medicine
Evidera
Seema Betigeri, MS, PhD
Director Global Regulatory Affairs
Merck & Co., Inc
Sabine Haubenreisser, MSc, PhD
Principal Scientific Administrator
European Medicines Agency
Laura Koontz, PhD
Director, Regulatory Policy
Joshua Ransom, PhD
Head of RWE Implementation and Innovation
Medidata Solutions
Real-world data can come from many sources – the analysis of such data can generate real-world evidence that can support safety information on products. The US FDA recently released their framework for using real-world evidence in support of effectiveness decisions. The increasing amount of data available through registries, electronic health records and/or social media provides the opportunity to consider leveraging real-world evidence in any development program to ultimately save time and cost.
The 21st Century Cures Act mandate the FDA to develop a real-world evidence framework to support using such data for effectiveness decisions.
The session will analyze the framework including any subsequently released guidance through case studies to guide the regulatory affairs professional in efficient implementation of real-world data use to support the development program. What constitutes ‘regulatory grade’ real-world data, how should it be presented and what is the best use to support regulatory decision making on effectiveness decisions? Presentations by industry experts and regulators as well as a ‘mock up live’ case study, participants will gain strategic insights to leverage real-world data in real-world evidence generation.