The Chicagoland Chapter of ACRP is proud to announce that we will be hosting Barbara Rusin, Sr. Manager Regulatory Compliance at MMS Holdings Inc., and a former FDA Investigator, for an educational event exploring patient eligibility, medical histories, and their regulatory implications on Wednesday, October 2nd, 2019.
Barbara’s presentation, ”Everyone Has a Medical History Worth Knowing – Especially Your Study Patient,” 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.
The event will be held at the Erie Café, 536 W Erie St, Chicago, IL 60654, with doors opening at 4:30pm. Agenda is as follows:
4:30 – 6 pm – Registration & Networking
6:00 – 7:30 pm – Educational Presentation
7:30 – 8:00 pm – Q&A
8:00 – 8:30 pm – Networking
Additional details and the link to registration will be available soon. Keep an eye out and mark your calendars!