Twin Cities Minnesota

SOCRA Twin Cities Chapter Meeting

Annual Education Conference

Saturday March 3, 2018 9:00-4:00 pm

Abbott Plymouth Campus Auditorium

Registration opens at 8:45 am


  • Impact of ICH E6 update and FDA guidance on monitoring
  • Methods for identifying risks, determining thresholds, and corrective and preventative actions
  • How to prioritize monitoring to focus on critical data, patient safety, and regulatory risk
  • Practical risk management strategies for sites
  • Identify the contents of a Clinical Evaluation Report per MEDDEV 2.7/1 rev. 4;
  • Identify submission requirements;
  • Understand purpose of each of the elements and their application in demonstrating clinical evidence of the medical device;
  • Introduction to MEDDEV 2.7/1 REV. 4, A3 Device Description and Alignment with Medical Device Labeling, Technical Files and Design Dossiers
  • Identify recent trends that are influencing patient recruitment
  • Discuss traditional patient recruitment tactics and how those methods are expanding
  • Successes and Struggles in the changing landscape
  • Encourage participants to think differently in the way they approach patient recruitment and retention
  • Discuss the different ways that fraud is committed by sponsors and investigators including the possible civil and criminal penalties
  • Describe the False Claims Act and protections afforded to whistleblowers
  • Review the February 2010 proposed rule that requires sponsors to report suspected falsification of data to the FDA


Please RSVP to: Karen Snaza,




First Floor Auditorium

5050 Nathan Lane North

Plymouth, MN 55442



Hwy 169 and Schmidt Lake Road (49th Ave)

Please enter at the main entrance on Nathan Lane (circular driveway).

Please check-in at the receptionist desk-someone will escort you to the meeting room



9:00 am                        Welcome

9:10 am                        Susan Wiskow-ICH E6 Updates and Impact on Monitoring

10:10 am                      Janice Kruse and Anita Whitaker-Clinical Evaluation Report (CER)

11:15 am                      Break

11:30 am                      Brianna Nelson and Allison Wood (Threewire)-Patient Recruitment in Light of Recent Industry Trends

12:30 pm                      Networking onsite

1:45-3:45 pm                Paul Below-You’ve Discovered Fraud-Now What Do you Do?                       

4:00 pm                        Closing Remarks and Adjourn


CE: SOCRA members will have the opportunity to earn 5 CEUs.

Certificate of Attendance for SOCRA members will be provided at the conclusion of the conference.