B21 – Opportunities and Challenges With Real World Clinical Data and Regulatory Initiative

Recently FDA has taken the initiative encouraging the use of real world data (RWD) for regulatory submissions. This brings in new opportunities and challenges in terms of a new innovative and cost effective approach to design clinical trials and observational studies.

 

The symposium will discuss the

(1) international scenario in the use of real world primary / ambulatory care data to generate population level evidences;

(2) new opportunities with the FDA initiative of using RWD;

(3) the opportunities and challenges in designing late phase clinical trials and observational studies with RWD; and

(4) the Australian scenario with RWD.

 

Chairperson:  Professor Sanjoy Paul, Melbourne EpiCentre, University of Melbourne