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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Hosted Session/Non-CE: Case Study hosted by Parexel: Transforming Evidence Generation: Scalable Solutions for Complex Requirements

Session Chair(s)

  Sponsored Sessions

Sponsored Sessions

United States

Parexel is conducting a post-authorization safety study (PASS) and registry build to assess the long-term safety of a drug treating a rare neurological disease. The study, mandated by EMA's PRAC, aims to characterize and quantify potential risks and address queries from European regulators. With the development of a novel data ingestion and analysis engine to process over 15 disparate sources, data is transformed into a common model for segmentation and analysis. This creative approach allows our customer to effectively assess product safety in line with regulatory mandates while maintaining access to the novel medicine for the rare and vulnerable patient population.

Learning Objective : Featured Topics:
  • Innovative frameworks and infrastructure for all stakeholder needs
  • Integrated evidence platforming across the product lifecycle
  • Best practices for scalable evidence generation

Speaker(s)

Mike  D’Ambrosio

Exhibitor

Mike D’Ambrosio

Parexel, United States

Senior Vice President and Global Head, Real World Research (RWD/RWE)

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