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

Objectives:

  • 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, Karen.Snaza@abbott.com

 

Location:

Abbott

First Floor Auditorium

5050 Nathan Lane North

Plymouth, MN 55442

 

Directions:

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

 

Agenda

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.