Use of RWE in Clinical Development to Enhance Regulatory Submission

Register free: http://www.appliedclinicaltrialsonline.com/act_w/enhance

Event Overview:

More pharmaceutical companies are working to understand how real-world evidence can strengthen their submission packages and identifying opportunities to do this across their portfolios. Pragmatic trials that combine the benefits of randomized controlled trials and real-world research are emerging to produce evidence that is fit for regulatory purposes and more. Innovative long-term follow-up methods drive efficiencies, particularly for gene therapies. External comparators provide context for clinical trials including submissions of single-arm trials. Regulatory agencies have signaled increased receptivity to the use of real-world evidence (RWE) in regulatory submission in both the U.S. and global markets.

Register for this Webinar to hear first-hand from a unique combination of real-world experts focused on hybrid study designs who have achieved regulatory success in bringing innovative methods forward.

Key Learning Objectives:

• Improved understanding of global receptivity to RWE in Regulatory Submission including FDA, EMA, and Japan

• Understand how to identify an opportunity for RWE to inform submission package for your product or portfolio

• Use cases of real-world evidence in Regulatory Submission for effectiveness, especially for label expansions

Speakers: Nancy Dreyer, PhD, MPH, FISPE, Fellow, DIA, Chief Scientific Officer, IQVIA Real World Solutions, IQVIA

Nathalie Horowicz-Mehler, PhD, MPH, Senior Principal, Head of Real World Evidence Strategy, IQVIA

Time and date: Tuesday, Apr. 7, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until Apr. 7 2021.

Sponsor: IQVIA 

Register free: http://www.appliedclinicaltrialsonline.com/act_w/enhance