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Registries: Supercharging Real-World Evidence for Drug Development and Approval

 
  May 15, 2024  
     
 
Xtalks, Online
2024-06-06


Discover an informative webinar that focuses on the evolving role of registry data in product development, approval and post-marketing value demonstration, as well as the advantages they offer.

The use of real-world evidence (RWE) in drug development has been fueled by the increased acceptance of RWE by stakeholders such as regulatory agencies, health technology assessment bodies and payers, as well as the plethora of real-world data (RWD) sources.

Protocolized disease registries are purpose-built for research, making them one of the most clinically rich sources of RWD. Registries allow the collection of fit-for-purpose data and are an acknowledged source for observational RWE generation, especially in rare diseases where a small number of patients are distributed across broad geographies.

Registries are most often used to fulfill post-approval safety commitments, to monitor or compare treatment patterns and effectiveness outcomes in the real world and to describe the natural history of diseases. In this webinar, the speakers will focus on the following topics:

The type of RWD that can be collected in registries
How RWD can be used to conduct nested, customized registry-based studies
Within one registry, how can it be ensured that data are collected consistently across patients, practice settings, geography and time?
Is there an existing registry that collects the required data or is a bespoke registry required?
What do regulators say about using RWD from registries to inform their decision-making?
Can registry data be used and linked to other data sources?
How can you go from data to actionable insights?

Read more...

Register for this webinar to gain insights into how RWE and RWD from registries enhance clinical development, approval and post-marketing analyses, particularly for rare diseases.

Keywords: Drug Development, Drug Discovery, Clinical Research, Clinical Data, Regulatory, Rare Diseases/Orphan Drugs, Commercialization/HEOR/Market Access
 
 
Organized by: Xtalks
Invited Speakers: Peter Wahl, MLA, MS, ScD, Vice President and Global Head of Scientific Affairs, CorEvitas, part of the PPD clinical research business of Thermo Fisher Scientific
Heather Litman, PhD, Vice President of Biostatistics, CorEvitas, part of the PPD clinical research business of Thermo Fisher Scientific
Delphinie Saragoussi, MD, MScPH, Executive Director, Real-World Evidence, Epidemiology and Scientific Affairs, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific
Nahila Justo, PhD, MBA, Executive Director, RWE Integrated Solutions, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific
Javier Cid, MD, DrPH, MBA, Senior Research Scientist, Data Analytics, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific
 
Deadline for Abstracts: 2024-06-06
 
Registration: Free Registration
E-mail: tristan@xtalks.com
 
 
   
 
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