Live Webinar Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

This webinar highlights some of the potential uses of RWD, and describes the factors that FDA considers when evaluating whether specific RWD is of sufficient quality to inform or support a regulatory decision. It will also clarify when an Investigational Device Exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device.


Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. 

Examples of RWD include data derived from electronic health records (EHRs), claims and billing data, data from product and disease registries, patient-generated data including in home- use settings, and data gathered from other sources that can inform on health status, such as mobile devices. RWD sources (e.g., registries, collections of EHRs, and administrative and healthcare claims databases) can be used as data collection and analysis infrastructure to support many types of trial designs, including, but not limited to, randomized trials, such as large simple trials, pragmatic clinical trials, and observational studies (prospective and/or retrospective ). 

Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. 

Under the right conditions, data derived from real world sources can be used to support regulatory decisions. RWD and associated RWE may constitute valid scientific evidence depending on the characteristics of the data. 

Why you should attend:

Under the right conditions, RWE may be suitable to support the clearance or approval of a new device, or the expansion of the indications for use of devices that are already on the market. RWE may also be used to supplement the total evidence required for such clearances or approvals. Other applications of RWE in premarket decision-making may also be possible, particularly as RWD systems and analysis methodology advance. 
Additionally, aggregation of RWD (e.g., in medical device registries) may prove useful as a postmarket control suitable for providing ongoing device safety surveillance and additional evidence for effectiveness.

Areas Covered

- Introduction and Scope
- Background
- Real-World Evidence
- Regulatory Context in Which RWE may be used
- Characteristics of RWD
        • Relevance
        • Reliability
                ? Data accrual
                ? Data assurance – QC
- Examples where RWE is used
        • Expanded Indications for Use
        • Postmarket Surveillance Studies
        • Post-Approval Device Surveillance as Condition of Approval
        • Control Group
        • Supplementary Data
        • Objective Performance Criteria and Performance Goals

Who will Benefit

•    Quality Managers
•    Quality Engineers
•    Regulatory Affairs
•    Small business owners
•    GxP 
•    Consultants
•    Quality VPs
•    IT VPs

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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