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Twin Cities Chapter: Preparing for GCP Inspections Under the MDR Paradigm

2.0
RAC Credits
Thursday, 27 February 2020 (5:30 PM) - Thursday, 27 February 2020 (8:30 PM) Central Time (US & Canada)
9750 Rockford Rd
Plymouth, Minnesota, USA, 55442-2893

*Student: $20
RAPS Member: $30

Nonmember:  $45

*Fax/email in a completed registration form to get the student rate.

Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be observed for designing, conducting, recording and reporting on clinical trials that involve the participation of human subjects. Being properly prepared for GCP inspections is critical to getting devices approved for market.

Come join others from the local regulatory community to hear an interactive presentation on this important process, specifically under the paradigm for the EU’s new Medical Device Regulation (MDR). Our presenter will cover pressing questions including:

  • With the change to the EU MDR 2017/745, what can we expect competent authorities to be looking for when they inspect clinical investigation sites?
  • How can we prepare clinical investigation sites, CROs and your internal processes to be able to show strong compliance with expectations?

This program, hosted by St. Cloud State University at Plymouth, is brought to you by the RAPS Twin Cities Chapter to promote knowledge sharing and engagement among local regulatory professionals. Dinner will be provided, and RAC holders may claim two RAC recertification credits.

Featured Speaker:
Jackie Torfin, vice president, regulatory, quality and clinical, CHF Solutions Inc.

 

Register