Setting the Standard for Real-World Evidence: Research Methods and Data Quality for Medical Devices

The use of real-world evidence (RWE) in medical-device evaluation continues to gain traction across the medical-device ecosystem, including in applications for regulatory purposes. Understanding what constitutes valid scientific evidence remains a challenge to the use of this approach.

To meet this need, operable standards are being developed to ensure relevance and reliability of data used in RWE studies, and these standards are being tested with user groups who design, execute, submit and interpret RWE studies. The NESTcc Research Methods and Data Quality Frameworks are intended to serve as guides and playbooks for medical-device ecosystem stakeholders to ensure the quality of data and research methodology. The frameworks build upon existing bodies of work and leverage expert stakeholders’ knowledge and experience from similar initiatives, including PCORnet, FDA’s Sentinel Initiative, and MDEpiNet.

Featuring panelists with industry, regulator and health-system perspectives, this workshop will outline the key principles and considerations in designing and executing an RWE study that demonstrates the fitness for purpose of real-world data.

Registration Fees & Deadlines

28 March 2022 – 5 July 2022: Early Bird $150 Member | $175 Nonmember

6 July 2022 – 5 August 2022: Regular $175 Member | $200 Nonmember

Learning level

Strategic - Content is intended for individuals who are well-versed in most/all concepts associated with the topic(s) and are involved in translating knowledge into effective plans and strategy. They work with other teams throughout the product lifecycle. Typical job titles at this level are director/vice president/executive director/CEO/experienced reviewer/section manager/division director.

Learning Objectives:

• Define expectations for methods and data sources for executing different types of real-world evidence studies
• Describe specific recommendations on research methodology and data quality for regulatory applications
• Identify key approaches to demonstrating the fitness for purpose of real-world data

Agenda

20 min introductory presentation; 45 min panel discussion; 10 min Q&A

Presenter:

Sandra Siami, MPH, NESTcc

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.

Questions