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Paul Below has done the following community presentations:
- "Employing a Quality Systems Management Approach to Improve Clinical Trial Monitoring"
ACRP Workshop Weekend, Las Vegas, NV
October 2008
- "Fraud at Investigator Sites - Tales from the Trenches and Lessons Learned"
Advocate Health Care "Achieving Excellence in Clinical Research" Conference, Chicago, IL
September 2008
- "FDA Inspections of Investigator Sites"
MAGI’s 2008 Clinical Trial Agreements, Budgets & Regulatory Conference – EAST, Arlington, VA
May 2008
See presentation & references
- "Employing a Quality Systems Management Approach to Improve Clinical Trial Monitoring"
ACRP 32nd Annual North American Conference, Boston, MA
May 2008
- "Where the FDA Regulations End and ICH GCP Begins"
North Central Regional Chapter SoCRA, Minneapolis, MN
April 2008
See presentation & references
- "Warning: Your Monitoring is Inadequate - Applying a Quality Systems Approach to Ensure Quality Monitoring"
ACRP Workshop Weekend, Baltimore, MD
October 2007
- "Where the FDA Regulations End and ICH GCP Begins"
SoCRA 16th Annual Conference, Denver, CO
September 2007
See presentation & references
- "Fraud at Investigator Sites – Tales
from the Trenches and Lessons Learned"
Minnesota Chapter ACRP, St. Paul, MN
Presented with Ann Marie Cisneros, Independent Clinical Research
Consultant
August 2007
- "Warning! Your Monitoring Is Inadequate: Applying a Quality Systems Approach to Ensure Monitoring Success" (1/2 day workshop)
ACRP 31st Annual North American Conference, Seattle, WA
Presented with Deidra Poucher, Independent Clinical Research Consultant
April 2007
See presentation & references
- "Fraud at Investigator Sites – Tales from the Trenches and Lessons Learned"
ACRP 31st Annual North American Conference, Seattle, WA
Presented with Deidra Poucher, Independent Clinical Research Consultant
April 2007
- "Fraud and Misconduct at Investigator Sites"
Chicagoland Chapter ACRP, Chicago, IL
November 2006
See presentation & references
- "Fraud and Misconduct at Investigator Sites"
SoCRA 15th Annual Conference, Chicago, IL
September 2006
See presentation & references
- "Monitoring Clinical Trials for Quality"
Class lecture - Understanding Medical Research (BIO 265), College of St. Catherine, St. Paul, MN
April 2006
- "State Laws That Impact Clinical Research"
Research Triangle Park Chapter ACRP, Durham, NC
November 2005
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Research Triangle Park Chapter ACRP, Durham, NC
November 2005
See presentation & references
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Atlanta Chapter ACRP, Atlanta, GA
October 2005
See presentation & references
- "Advanced Monitoring Workshop"
Medical Alley Clinical Studies Special Interest Group, Minneapolis, MN
October 2005
See presentation and references
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Central New York Chapter ACRP, Binghamton, NY
October 2005
See presentation & references
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Clinical Trials Office, State University of New York – Upstate Medical University, Syracuse, NY
October 2005
See presentation & references
- "State Laws and Clinical Research – What Investigator Sites Need to Know"
ACRP 29th Annual North American Conference, Orlando, FL
Presented with Janet Petrell, Independent Contract CRA
April 2005
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Southeast Louisiana Chapter ACRP, Metairie, LA
March 2005
See presentation & references
- "State Laws and Clinical Research – What Investigator Sites Need to Know"
Minnesota Chapter ACRP, Edina, MN
Presented with Janet Petrell, Independent Contract CRA
March 2005
See presentation & references
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Philadelphia Chapter ACRP, Cayman Islands (Cruise Symposium)
February 2005
See presentation & references
- "Advanced Monitoring Workshop"
Medical Alley Clinical Studies Special Interest Group, Minneapolis, MN
Presented with Barbara Westrum, Medtronic, Inc.
October 2004
- "Introduction to the Association of Clinical Research Professionals”
Mayo Clinic, Department of Cardiology – Research, Rochester, MN
October 2004
- "Fraud and Misconduct at Investigator Sites"
Southeast Louisiana Chapter ACRP, Metairie, LA
Presented with Kerrin Young, BioSante Pharmaceuticals
August 2004
- "A CRA’s and Auditor's Perspective on the Impact of the HIPAA Regulations”
ACRP 28th Annual North American Conference, San Diego, CA
Presented with Terri Kelly, GCP Consulting, Inc.
May 2004 (repeated twice)
See presentation & references
- "Utilizing Electronic Tools for Effective ACRP Chapter Communications”
ACRP 28th Annual North American Conference – Chapter Chairs Workshop, San Diego, CA
May 2004
- "Introduction to the Association of Clinical Research Professionals”
Anoka-Ramsey Community College, Biomedical Technology Class BMED 2297 – Field Experience and Seminar, Coon Rapids, MN
February 2004
- "Measuring Up as a Monitor"
Minnesota Chapter ACRP, St. Louis Park, MN
June 2003
- "Anatomy of an ACRP Chapter”
ACRP 27th Annual North American Conference – Chapter Startup Breakfast, Philadelphia, PA
April 2003
- "Clinical Study Monitoring Workshop"
Medical Alley Clinical Studies Special Interest Group, Minneapolis, MN
April 2003
- "Fraud and Misconduct at Investigator Sites"
Great Plains Chapter ACRP, Omaha, NE
March 2003
- "Similarities and Differences in Conducting Medical Device and Pharmaceutical Clinical Trials"
North Central Regional Chapter, Society of Clinical Research Associates and the Minnesota Chapter ACRP, Minneapolis, MN
Presented with Barbara Westrum, Medtronic, Inc.
February 2003
- "Good Clinical Practices in Pharmaceutical Research"
Clinical Trials Office, Iowa Methodist Hospital, Des Moines, IA
September 2002
- "Clinical Study Monitoring Workshop"
Medical Alley Clinical Studies Special Interest Group, Minneapolis, MN
Presented with Barbara Westrum, Medtronic, Inc.
April 2002
- "Understanding 21 CFR Part 11: Electronics Records and Signatures"
Minnesota Chapter ACRP, St. Louis Park, MN
January 2002
- "Advanced Clinical Study Monitoring Workshop"
Medical Alley Clinical Studies Special Interest Group, Minneapolis, MN
Presented with Barbara Westrum, Medtronic, Inc.
May 2001
- "The ICH Guidelines for Good Clinical Practice – Differences with FDA and the Impact on Investigator Sites"
Minnesota Chapter ACRP, St. Louis Park, MN
March 2001
Paul Below has done the following corporate presentations:
- "Medical Device GCP 2 Day Seminar (ACRP)"
Roche Diagnostics, Indianapolis, IN
October 2008
- "1 Day GCP Seminar"
Colorado Orthopedic Consultants, Aurora, CO
July 2008
- "Fraud at Investigator Sites – Tales from the Trenches and Lessons Learned"
Children’s Hospital Research Department, Dallas, TX
June 2008
- "2 Day GCP Seminar"
DaVita Clinical Research, Minneapolis, MN
March 2008
- "Fraud and Misconduct at Investigator Sites"
Clinical Operations Department, MGI Pharma, Bloomington, MN
November 2006
- "Fraud and Misconduct at Investigator Sites – A CRA’s Perspective"
Regional Clinical Research, Inc. (Investigator Site), Binghamton, NY
October 2005
- "Pediatric Clinical Trials"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Armonk NY
November 2003
- "State Laws and Clinical Research"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Armonk NY
November 2003
- "Investigator Database Overview"
Clinical Operations and Clinical & Scientific Affairs Divisions, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
November 2003 (three sessions)
- "HIPAA Privacy Rule"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals (by webcast)
June 2003 (two sessions)
- "Using Windows XP and Secure E-mail"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Tarrytown NY
May 2003
- "Fraud and Misconduct at Investigator Sites"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Tarrytown NY
May 2003
- "HIPAA Privacy Rule"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Tarrytown NY
May 2003
- "HIPAA Privacy Rule"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Tampa, FL
April 2003
- "FDA Inspections of Investigator Sites"
Medical Affairs Department, 3M Pharmaceuticals, St. Paul, MN
March 2003
- "Fraud and Misconduct at Investigator Sites"
Medical Communications Section, Medical Affairs Department, 3M Pharmaceuticals, St. Paul, MN
Presented with co-workers from the Clinical Operations Section
February 2003
- "Fraud and Misconduct at Investigator Sites"
Clinical Operations Section, Medical Affairs Department, 3M Pharmaceuticals, St. Paul, MN
Presented with co-workers from the Clinical Operations Section and the Compliance Audit Unit
September 2002
- "Introduction to Good Clinical Practice"
Quarterly new employee orientation of the Medical/Drug Regulatory Affairs Division, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
August 2001
- "Understanding 21 CFR Part 11: Electronics Records and Signatures"
Medical/Drug Regulatory Affairs Division, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
July 2001
- "History and Development of Food and Drug Regulation"
Quarterly new employee orientation, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
June 2001
- "FDA Inspections of Investigator Sites"
Clinical Field Operations and Regulatory Affairs Departments, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
February 2001
- "How State Laws and Regulations Affect Clinical Research"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
August 2000
- "Corporate Monitoring SOP and Working Instruction Revisions due to ICH"
Medical/Drug Regulatory Affairs Division (two sessions) and Clinical Field Operations Department (one session), Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
March-April 2000
- "Preventing Common Problems during Routine Site Visits"
Clinical Field Operations Department, Boehringer Ingelheim Pharmaceuticals, Norwich, CT
September 1999
Paul Below has done the following scientific presentations:
- "Thermoregulation during Exercise in the Heat"
Physical Therapy Department, University of Minnesota, Minneapolis, MN
November 2001
- “Reductions in cardiac output, mean blood pressure and skin vascular conductance with dehydration are reserved when venous return is increased”
Poster presentation at the American College of Sports Medicine National Meeting, Indianapolis, IN
June 1994
Published in: Medicine and Science in Sports and Exercise, 26(5): S 163, 1994
- “Fluid replacement and carbohydrate ingestion individually benefit intense exercise lasting about one hour”
Free communication at the American College of Sports Medicine National Meeting, Seattle, WA, June 1993
Published in: Medicine and Science in Sports and Exercise, 25(5): S3, 1993
- "Fluid Replacement for Marathon Runners"
Motorola Marathon Pre-Race Symposium, Austin, TX,
April 1995 and April 1996
- "Work and Fluid Replacement Guidelines to Prevent Heat Stress in Firefighters"
City of Austin Fire Department Cadet Training Class, Austin, TX
March 1993
- "Sports Nutrition for the Wheel Chair Athlete"
2nd Annual Wheel Chair Sports Symposium, Southwest Texas State University, San Marcos, TX
April 1992
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