Evaluation expires on 11/2/2019

Barbara Rusin, Sr. Manager Regulatory Compliance at MMS Holdings Inc., and a former FDA Investigator, will be presenting “Everyone Has a Medical History Worth Knowing – Especially Your Study Patient.” She will discuss regulatory implications of enrolling ineligible subjects – to the sponsor and clinical site – and how to prevent this by obtaining and properly reviewing medical histories, and what to do when records are not readily available. The presentation will also touch on the differences in the regulatory landscapes of the US and the EU regarding patient eligibility, health records, and study waivers.

Learning Objectives:

The regulations and guidelines relevant to enrollment of eligible subjects in the EU and US
Why enrollment of an ineligible subject is so concerning to regulatory authorities and the impact on study analysis
Regulatory outcomes of enrollment of ineligible subjects
What medical histories are necessary and how to maintain adequate documentation
How to review medical histories and manage conflicting information
Difficulties with obtaining medical histories
What to do when medical histories are not readily available
Use of waivers in US vs EU

Barbara Rusin MS

Senior Manager Regulatory Compliance, MMS Holdings, Inc.

Appearances