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Monday, June 17 • 3:30pm - 4:30pm
#148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-547-L04-P; CME 1.00; RN 1.00

This session delves into the latest guidance on real-world data (RWD) and real-world evidence (RWE), offers insights from case studies in which such data were critical for regulatory decisions, and discusses how to prepare the next generation of medical writers for this complex landscape.

Learning Objectives

Analyze the FDA’s current stance and guidance on real-world data (RWD) and real-world evidence (RWE) in regulatory submissions; Compare real-world applications of RWD and RWE, showcased through several case studies; Outline educational strategies for equipping future regulatory and medical writers with the skills and understanding needed to effectively incorporate RWD and RWE into documentation.

Chair

Jeanette Towles, MA

Speaker

Industry Update
Craig Ostroff, PharmD

Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Tina Schlecht, PharmD, MBA


Speakers
avatar for Jeanette Towles

Jeanette Towles

President and CEO, Synterex, Inc., United States
Jeanette Towles, MA, RAC, is the CEO of Synterex, Inc., a woman-owned, disability-owned clinical and regulatory consulting firm specializing in agile-based project management methodology, automation, and AI-driven technologies. Prior to that, she held in-house consulting and FTE medical... Read More →
CO

Craig Ostroff

Chief Executive Officer, Mill Street Consulting, LLC, United States
avatar for Tina Schlecht

Tina Schlecht

Chief Pharmacy Officer, RxE2, United States
Tina Schlecht, PharmD, MBA is Chief Pharmacy Officer at RxE2 In. She brings 25 years of experience in pharmacy and industry to RxE2. She began her career at CSM, where she led the growth of CTRP services and went on to be President of Center Point Clinical Services. She also worked... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session