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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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.
28 March 2022 – 5 July 2022: Early Bird $150 Member | $175 Nonmember
6 July 2022 – 5 August 2022: Regular $175 Member | $200 Nonmember
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.
20 min introductory presentation; 45 min panel discussion; 10 min Q&A
Sandra Siami, MPH, NESTcc
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 firstname.lastname@example.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 email@example.com with the event title, name of the original registrant and the contact information for the new attendee.
RAPS will send an electronic letter or a certificate of attendance at the following the workshop.