Key Speakers

Jesper Kjær

Director of Data Analytics Centre

Danish Medicines Agency

John Cai

Executive Director, Real World Evidence and Analytics Innovation

Merck

Shrividya Iyer

Executive Director, Oncology Worldwide Real World Evidence (RWE) & US HEOR

Eisai

Yun Lu

Mathematical Statistician, Office of Biostatistics and Pharmacovigilance

FDA, CBER

David Martin

Vice President, Clinical Safety and Risk Management

Moderna

Kelly H. Zou

PhD, PStat®, FASA Head Global Medical Analytics and Real World Evidence

Viatris

Kenneth Quinto

Senior Medical Advisor for Real World Evidence Analytics

FDA

Khaled Sarsour

Vice President, Data Science Real World Evidence and Insights

Janssen

Welcome to the 10th IMPACCT RWE Summit

Optimizing Real World Evidence to Expedite Regulatory Approval, Reimagine Clinical Trials, and Deliver Value for Patients

Returning in person for its 10th year anniversary, the IMPACCT: Real World Evidence Summit will deep dive into the use of RWE for regulatory submissions and improved clinical trial design to help you navigate the regulatory landscape.

Following recent FDA and EMA guidelines, this comprehensive industry-led forum will address how drug developers can leverage RWE from beginning to end of study, ensure clinical studies are well-designed, include appropriate protections for their patients and upload data integrity.

Join 100+ senior leaders in RWE, RWD, real world analytics experts & epidemiologists from pharma and biotech to take part in this three day summit with over 18 hours of exclusive content.

What’s New in 2022?

This year brought a new regulatory landscape for real world evidence, broadening the horizons for the role of RWE in drug development. From regulatory approvals to improved trial design, this new landscape opens a new set of industry challenges.

The 10th IMPACCT RWE Summit will return in October to explore exclusive case studies on:

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Creating a robust, regulatory-compliant RWE framework and data package for successful IND filing

Navigating the global regulatory environment for RWE applications particularly for the FDA and EMA

Advancing data acquisition and analytics technology and techniques to enhance informed R&D and clinical decision making

Leveraging RWE in your clinical activities – from patient selection to synthetic control arms

 

Maximizing your product lifecycle through comprehensive observational data programs

 

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