Clinical Evidence Writing for Medical Device Regulatory Submissions

Data used to support regulatory submissions comes from many sources. Clinical evidence can be found in the published literature, company complaints, and in publicly available databases like the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. In this web seminar, we will review how to gather and extract pertinent data from these sources to develop an appropriate analysis for your product and submission. Attendees will learn how to identify quality clinical evidence and utilize it in regulatory submissions.

• Discuss the different types of clinical evidence available
• Identify the limitations of clinical evidence
• Describe the content of clinical evidence analysis

• Regulatory Affairs Professionals
• Medical Writers

Joy Frestedt, Ph.D., C.P.I., R.A.C., F.R.A.P.S.

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$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-15-083-L01-P. Released: 8/15. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.