5 October - 14:00 -15:00 BST / 15:00 – 16:00 CET

The role of real-world evidence in regulatory decision making: current use and future potential 

The consideration of Real-World Evidence (RWE) in regulatory decision making is nothing new, and for decades such evidence has been used in the post-authorization phase, predominantly to monitor post-marketing safety. What has changed, is the tremendous increase in both the supply and demand of RWE and real-world data (RWD) in support of regulatory decision making. 

Supply-wise, data acquisition has dramatically accelerated, facilitated by modern digital technologies, leading to increased data volume and variety in health data. On the demand side, we are facing a rapidly changing evidence generation landscape with increased relevance for RWE in support of regulatory decision-making, not only to inform on risks but also on benefits of new health technologies. 

Although the acceptance of these data in the regulatory context is still an evolving area, the ongoing releases of guidance documents on the use of RWE by both EMA and FDA underscores the growing importance of RWE in regulatory decision making. 
As a result, regulatory and drug development professionals need to understand RWE's potential applications, along with the strengths and limitations of various approaches.

This webinar will describe the current state of RWE scientific advancements and provide context for the regulatory and research implications of RWD and RWE. 

Learning objectives: 
• Define real-world data/real-world evidence (RWD/RWE) and highlight current examples 
• Elaborate upon the regulatory perspective & provide key understandings from their (draft) guidance documents, frameworks, and ongoing initiatives. 
• Evaluate future prospects for RWE as it continues to evolve, including strengths and opportunities for development

Who will benefit:
• Regulatory affairs staff
• R&D personnel
• Medical affairs staff 
 
Presenters


Dr Chantal Van Gils, NDA Advisory Board: Director of Epidemiology and Real-World Evidence

Chantal is a seasoned specialist in real-world research, epidemiology and health economics. She brings extensive knowledge and a wealth of professional experience in harnessing population-specific analyses and quantitative methods to inform both interventional and observational clinical studies including pragmatic trials, natural history of diseases, registry-based data, patient-related outcome reports or multi-dimensional molecular medicine data.

This expertise is critical to inform development and regulatory decision-making along the value chain and product life cycles, based on integrated evidence planning.  

She provides strategic advice and scientific leadership to support clients in clinical development, registration strategy, submission, early post-approval strategy or other health authority interactions for high priority programs and/or non-interventional studies across all therapeutics areas, and notably oncology and ATMP.
 
 This webinar is sponsored by NDA Group.

Disclaimer: Whilst TOPRA is running this webinar for NDA Group, this is not an endorsement of NDA Group, NDA Group's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

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Pricing

• Members: free
• Non-members: free

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