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Past Presentations
- Liability Issues with Clinical Trials
Robert Klepinski, Officer with Fredrikson & Byron, P.A.
September, 2008 - view presentation PowerPoint (777 KB)
(NOTE: Mr. Klepinski's slides are available on our web site for your educational use to supplement the live presentation. These copyrighted slides are not to be copied for any commercial purpose. You may not copy or use them, other than as an aid in your understanding the subject matter of our class).
- Statistics: Considerations in Clinical Study Design and Execution
An Liu, MS., Principle Statistician, Medtronic, Inc. and President, A & L Consulting, LLC
November, 2007
- Topics in Clinical Research
Joy Frestedt, PhD, RAC, CCTI, Vice President/President-Elect, MN-ACRP
Sonali Gunawardhana, Regulatory Counsel, Office of Compliance, Division of Bioresearch Monitoring, Center for Devices and Radiological Health, U.S. Food and Drug Administration
October, 2007
- Clinical Trial Monitoring Service for Academic Sponsor-Investigators
Harvey M. Arbit, PharmD, MBA, RAC, Director, IND/IDE Assistance Program, Academic Health Center, University of Minnesota
Kathleen M. Mischke, BA, EMT,Clinical Trial Monitor, Academic Health Center, University of Minnesota.
September, 2007
- Fraud at Investigator Sites: Tales from the Trenches and Lessions Learned
Paul Below, CCRA , Principal, P. Below Consulting Inc.
Ann Marie Cisneros, MBA, BS, MT, President, CRA Solutions, Inc
August, 2007
- Clinical Trial Budgets and Contracts
Aaron Rodriguez, Senior Legal Counsel, Medtronic, Inc.
Andrew Snyder, Director of Research Administration, St. Paul Heart Clinic
Laura Williams, Senior Grants and Contract Administrator, University of Minnesota
Panel Members: Debra Dykhuis, Associate Director, Research Services Organization, University of Minnesota, and Kathryn Jones, Clinical Research Institute, Inc.
May, 2007
- Coaching: How to get MORE of what you want in life
Sayre Darling, Principal, Courageous Communications
February, 2007 - view presentation PowerPoint (683 KB)
- FDA Clinical Trial Requirements Conference
Numerous FDA and industry speakers
August 2006
- How to Prepare for an FDA Inspection
Christine Boes, Senior Manager, Clinical Quality, Cardiac Rhythm Disease Management, Medtronic, Inc.
March 2006 - view presentation PowerPoint (154 KB)
- Dos and Don’ts of Monitoring: An Interactive Discussion Between a CRA and CRC
Sarah Moeller, Principal Consultant, Integra CTS, and Karla McBrady, Marketing and Recruitment Coordinator & Clinical Research Coordinator, Clinical Research Institute
February 2006 - view Sarah Moeller's presentation PowerPoint (847 KB) and Karla McBrady's presentation PowerPoint (856 KB)
- Five Dysfunctions of a Team
Louise M. Miner, Organization Development Consultant, Mironet Consulting, Inc.
January 2006 - view presentation PowerPoint (261 KB)
- FDA's Critical Path Initiative: History, Objectives, Approach
Amy Johnson, Public Affairs Specialist, Minneapolis District Office, FDA.
November 2005 - view presentation PowerPoint (497 KB)
- Introduction to Statistics
Chris Mullin, Senior Statistical Consultant, Integra Clinical Trial Solutions.
October 2005 - view presentation PowerPoint (928 KB)
- Dirty Laundry Dialogue (Part II): Dirt from the Clinical Site Perspective
Andrew Snyder, MBA, FACMPE, PMP, Administrative Director of Research, and Beth Jorgenson,
RN, CCRC, St. Paul Heart Clinic, PA
May 2005 - view presentation PowerPoint (517
KB)
- State Laws and Clinical Research: What Investigator Sites Need to Know
Paul Below, Clinical Research Consultant, P. Below Consulting, Inc., and Janet Petrall, Independent Contract CRA
March 2005 - view presentation PowerPoint (1.48
MB)
- FDA Sponsor Inspections: How to Prepare and Survive
Christine Boes, Senior Manager, Clinical Quality, Cardiac Rhythm Management, Medtronic, Inc.
February 2005 - view presentation PowerPoint (1.24
MB)
- Conducting European Clinical Trials
Ann Quinlan-Smith, VP & Executive Principal Consultant,
Alquest, Inc., JeanAnn Hurm, Principal Consultant, Alquest, Inc.,
and Chris Cain, RN, MBA, Clinical Research Manager, CVRx.
December 2004
- Improving the Readability of Informed Consent and HIPAA Authorization Documents
Mark Hochhauser, Ph.D., Readability Consultant
November 2004
- A Dirty Laundry Dialogue: Coming Clean about IRBs, Sponsors & Study Sites
Tamara J. O’Black, CIP, Regulatory Affairs Administrator, Park Nicollet Institute
October 2004 - presentation PowerPoint (530
KB)
- Bioresearch Monitoring in Medical Devices: What's New and How to Prepare
Susan Rockwell, BA, MEd, Manager of Clinical Trials and Clinical
Development at Medical Device Consultants, Inc
September 2004
- Bridging the Gap in Site-Sponsor Communications
Deb Lasher, Park Nicollet Institute, and Judith Parker, Research Service
Organization - University of Minnesota
March 2004 - view
presentation PowerPoint (426 KB)
- Effective Scientific Communication: From the Scientist and Clinician to the Layperson
Mary Knatterud, Department of Surgery - University of Minnesota, and John Logie, Department of Rhetoric - University of Minnesota
February 2004
- Research Management Software: Take Operational and Financial Control of Your Research Efforts
Andrew Snyder, St. Paul Heart Clinic
November 2003 - view presentation PowerPoint (1.10 MB)
- Measuring Up as a Monitor - Making the Grade
Paul Below, Clinical Research Consultant, P. Below Consulting, Inc.
June 2003 - view presentation PowerPoint (1.19 MB)
- Fraud and Misconduct at Investigator Sites
Kerrin Young and Jeri Weigand, 3M Pharmaceuticals
April 2003 - view presentation PowerPoint
- Similarities & Differences in Conducting Medical Device & Pharmaceutical Clinical Trials
Paul Below, 3M Pharmceuticals, and Barb Westrum, Medtronic
February 2003 - view presentation PowerPoint
- INDs & IDEs: What They Are, Why We Need Them
Harvey Arbit, Academic Health Center - University of Minnesota
February 2003 - view presentation PowerPoint (293 KB)
- Study Site Feasibility in Academic and Private Practice Settings
Lisa Hostetler, Research Service Organization - University of Minnesota, and Kimberly Knish, Minnesota Eye Consultants
December 2002 - view presentation PowerPoint (669 KB)
- HIPAA - Are Your Ready?
Grace Wiechman, Park Nicollet Health Services
September 2002 - view presentation as PowerPoint (3.0 MB)
- Statistics in Clinical Research
Robyn Andersen, International Diabetes Center - Park Nicollet Clinic
June 2002 - view presentation PowerPoint (232 KB)
- Effective Recruiting Techniques: The Case for a Dedicated Recruiter…
Jeff Cosgrove, DaVita Clinical Research
March 2002 - view presentation PowerPoint (235 KB)
- Understanding CFR Part 11: Electronic Records and Signatures
Paul Below, Boehringer Ingelheim Pharmaceuticals
January 2002 - view presentation PowerPoint (329 KB)
- Research Subject Recruitment: Issues and Strategies (full day symposium)
Various Speakers
November 2001
- The ICH Guidelines for GCP: Differences with FDA Regulations and Their Impact on Investigator Sites
Paul Below, Boehringer Ingelheim Pharmaceuticals
March 2001 - view presentationPowerPoint (1.93 MB)
