克服当今主要监管挑战的行之有效的方法.pdf

1、Sponsored byMichael Thomas,Innovasis IncSharon Starowicz,OSMA FellowRyan Belaney,Phoenix KineticsProven Ways to Overcome Todays Top Regulatory ChallengesProven Ways to Overcome Top Regulatory ChallengesOSMA:Addressing Challenges as an IndustryThe Orthopaedic Surgical Manufacturers Association(OSMA)i

2、s a nonprofit organization composed exclusively of manufacturers specializing in orthopaedic surgical appliances,implants,instruments,equipment,and orthobiologics.OSMA is one of the longest-standing trade associations devoted to the manufacture of medical devices used in orthopaedic surgical procedu

3、res.OSMA Member CompaniesOSMA Mission:Striving to meet our vision through the following strategic objectives Session Agenda The Use of Real-World Evidence for Regulatory Submissions Orthopedic Alliance Roundtable MR Testing and LabelingProven Ways to Overcome Top Regulatory ChallengesReal-World Evid

4、enceIntroduction:Real-World Data(RWD)/Real-World Evidence(RWE)Challenge:Leverage RWE to increase regulatory approval efficiency and reduce clinical trial costs Objective:Explain the concept of real-world evidence(RWE)in the context of medical devices.Discuss current regulatory guidance and compare E

5、U and FDA perspectives Outline steps to use RWE to enhance product approval efficiency.Definition of Real-World Evidence(RWE)What is RWD/RWE?RWD:Healthcare data collected from sources other than clinical trials RWE:Derived from RWDImportance of RWE:Used today:To complement clinical trial data.Provid

6、es insights into long-term effects and broader patient populations.Uses tomorrow:Gain confidence to utilize RWE over:Post-market clinical trials Specific pre-market clinical trialsTypes of Real-World Data(RWD)RWD Sources:Electronic Health Records(EHRs):Clinical data from patient visits.Claims and Bi