Nancy J Stark, "“Clinical Trials: What to Do and How to Do It”, MDM Rosemont Conference & Exhibition, Rosemont, IL, 24 September 09.
Nancy J Stark, "Medical Device Adverse Events", Global ACRP Meeting,
Seattle, WA, 22 April 07.
Nancy J Stark, “From Claims to Protocols”, Regional RAPS Meeting,
Chicago, IL, 29 Sept 05.
Nancy J Stark, “Project Management
for Medical Device Trials”, two-day training at MedicoIndustrien, Copenhagen, Denmark, 15-16 Sept 05.
Nancy J Stark, “Biocompatibility
Testing & Management”, two-day training at MedicoIndustrien, Copenhagen,
Denmark, 13-14 Sept 05.
Nancy J Stark, "From Claims to Clinicals: How claims Set
the Specifications for Your Protocol", 2nd Meeting of Japan Forum of Clinical
Trials on Medical Devices, 3 Sept 05, Tokyo Japan.
Nancy J Stark, “European Medical
Device Regulation”, three-day training at FDA/CDRH, Washington, DC.
13-15 July 05.
Nancy J Stark, "A Comparison of ISO 14155 and ICH-GCPs",
Barnett/Paraxel Summit on Drug and Device Safety, 4 May 05, Philadelphia, MD
Nancy J Stark, "Data Management for Medical Devices:
Confusion and Controversy" DIA Data Management Conference, 9 Nov 04,
Amsterdam, The Netherlands.
Nancy J Stark, “Device
Clinical Trials in the European Union”, FDA/CDRH College, 27 April 04,
Rockville, MD.
Nancy J Stark,
“Clinical Research Practices in the Device Industry,” Center for Business
Intelligence conference on Pre-clinical and Clinical Trials for Medical Device
and Combination Products, 11-12 March 04, Minneapolis, MN.
Nancy J Stark,
“Regulated Databases: Navigating Computerized Systems Used in Clinical
Trials”, Center for Business Intelligence conference on Pre-clinical and
Clinical Trials for Medical Device and Combination Products, 11-12 March 04,
Minneapolis, MN.
Nancy J Stark,
“Project Management for Clinical Research,” ASQ New England, 18 Nov 03,
Needham, MA.
Nancy J Stark,
Keynote Address: “Clinical Research Practices in the Device Industry”, ASQ New
England, 18 Nov 03, Needham, MA.
Nancy J Stark,
“Basic Aspects and Principal Problems in the Management of a Clinical Study”,
DIA Second Latin American Congress of Clinical Research, 29 Sep-1 Oct 03,
Mexico City, Mexico.
Nancy J Stark,
“Clinical Databases and Part 11: The Regulated Database”, Orange County
Regulatory Affairs Society, 4-5 June 03, Irvine, CA.
Nancy J Stark,
“Clinical Databases and Part 11: A Layman’s Primer to System Documentation”,
DIA Device Conference, 24-25 Feb 03, San Francisco, CA.
Nancy J Stark, "HIPPA
Requirements and Their Effect on Clinical Research", RAPS Clinical Trials
Conference. August 5-6, 2002, Washington, DC.
Nancy J Stark, "Predicting the Future:
Clinical Research in the United States", SoCRA, Minnesota Local Chapter, June
13, 2002, Minneapolis, MN.
Nancy J Stark, "HIPPA--Health Insurance Portability
and Accountability Act", SoCRA, Minnesota Local Chapter, June 13, 2002,
Minneapolis, MN.
Nancy J Stark, "HIPPA--Health Insurance Portability and Accountability
Act", FDA/OCRA Educational Conference, June 3-4, 2002, Irvine, CA.
Nancy J Stark, "Case Study: Dulce Devices
Implementing ISO EN 14155-1 & 2", AAMI/FDA International Conference on Medical
Device Standards and Regulation, March 27-28, 2002, McLean, Virginia.
Nancy J Stark, "Current US Regulatory and Ethical
Issues in Clinical Research", Regulatory Affairs Professionals Society, March
20, 2002, San Francisco, CA.
Nancy J Stark, "Investigator Selection & Clinical
Study Monitoring", Medical Alley, March 13-20, 2002, St. Paul, MN.
Nancy J Stark, "Survey
of Clinical Research Practices: Medical Device Industry", July 18, 2001,
St. Paul, MN.
Nancy J Stark, "Current
Topics in Clinical Research", Biomedical Focus, July 18, 2001, St. Paul,
MN.
Nancy J
Stark, “Device Clinical Trials in the European Union”, FDA/CDRH College, 21
June 01, Rockville, MD.
Nancy J
Stark, “Current Topics in Clinical Research”, Medical Design & Manufacturing
East, 5 June 01, New York, NY.
Nancy J Stark, "Clinical Trials for Medical Devices",
Regulatory Affairs Professionals Society, October 2-4, 2000, Washington, DC.
Nancy J Stark, "Managing Subject Risk in Device
Trials", Association of Clinical Research Professionals, May 15-17, 2000, New
Orleans, LA.
Nancy J Stark, "Project Management: A Case Study,"
Institute for International Research Conference on Project Management for
Research & Development and Clinical Research, February 23-25, 2000,
Philadelphia, PA.
Nancy J Stark, "Clinical Trial Site Management",
Association of Clinical Research Professionals, April 21-24, 1999, Washington,
DC.
Nancy J Stark, "Clinical Trial Site Management",
Biomedical Focus, July 20-22, 1998, Minneapolis, MN.
Nancy J Stark, "Working with CROs", Biomedical Focus,
July 20-22, 1998, Minneapolis, MN.
Nancy J Stark, "Health-Based Risk Assessments",
Biomedical Focus, July 20-22, 1998, Minneapolis, MN.
Nancy J Stark, "Case Studies: Material Safety
Reviews", Medical Design & Manufacturing East97, June 1-5, 1997, New York, NY.
Nancy J Stark, "Using Foreign Clinical Data in US
Submissions", International Business Communications Conference, August 15-16,
1996, Williamsburg, VA.
Nancy J Stark, "Managing Positive Biological Safety
Result", Biomedical Focus X, July 15-17, 1996, Minneapolis, MN.
Nancy J Stark, "The Changing Clinical Research
Industry: A Challenge for the Future", Biomedical Focus X, July 15-17, 1996,
Minneapolis, MN.
Nancy J Stark, "Managing Positive Biological Safety
Results", Medical Design and Manufacturing West, February 6-8, 1996, Anaheim,
CA.
Nancy J Stark, "Policies of Quality and Management in
Cosmetic Dermatology", International Society of Cosmetic Dermatology, October
26, 1995, Montecatini Terme, Italy.
Nancy J Stark, "Solving Quality Problems in
Biocompatibility Management", Session Chair, Medical Design and Manufacturing
East, May 24-26, 1994, New York City, NJ.
Nancy J Stark, "Identity Documentation for
Materials", Medical Design and Manufacturing East, May 24-26, 1994, New York
City, NJ.
Nancy J Stark, "Materials and Surveillance
Screening—Why and How", Medical Design and Manufacturing East, May 25-27,
1993, New York City, NY.
Nancy J Stark, "Biological Safety: Design and
Planning Issues", Biomedical Focus VI Conference and Exposition, July 27-29,
1992, Bloomington, MN.
Nancy J Stark, "Materials Screening—Why and How",
Medical Design and Manufacturing West, February 4-6, 1992, Anaheim, CA.
