Quality and Reusability of Real World Data

Project Scope 

Within this project we will make a list of available data sources and pros and cons. We will discuss what documents and requirements we need to show the FDA in the pre-alignment meeting and we will try to point to or create an outline and/or requirements for those documents. If possible, we will align with the FDA on this.

Ashwin Rai, Thermo Fisher Scientific 

ashwin.rai@thermofisher.com

Berber Snoeijer, ClinLine

b.snoeijer@clinline.eu

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global 

Understanding the Data Quality Issues in Real World Data through Real World Examples

Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products

RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making