Medical Devices

Vigilance and Trend Reporting

Tuesday, October 27, 2020

14:45 – 15:45 CET

Session Leader/Speaker(s)

Keith Morel, PhD

VP, Regulatory Compliance
Qserve Group Inc. - ENTERPRISE
Belmont, California, United States

Speaker(s)

Leonard Buchner, MS

Principle Consultant
Qserve Group
SAN JOSE, California, United States

Slides

Description: This session will endeavor to give attendees some initial thoughts on HOW TO go about performing such trend analyses, things to consider (i.e. trade offs between false negatives and false positives), what is "statistically significant" and what is "practically significant" and what needs to be trended (and reported) - i.e. untangling the complex language in Art. 88. This will give the attendees knowledge they can use when reviewing/approving, or providing guidance for, plans/protocols/procedures which describe the methods and techniques for meeting Art 88.

Learning Objectives:

1. Upon completion, participants should understand HOW to identify statistically significant trends. i.e. appropriate statistical techniques. They should have an understanding of trade-offs between false negatives and false positives.
2. Upon completion, participants should understand WHAT needs to be trended (and reported) - i.e. untangling the complex language in Art. 88.
3. Upon completion, participants should understand what is "statistically significant" and what is "practically significant", and the consequences thereof (e.g. meeting Art 88 requirements, what to report).