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Clinical Research Presentations
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|Archives -- Clinical Research
|Clinical Trial Liability Concerns for Small Companies. Arena International’s 2nd Annual
Outsourcing in Clinical Trials Southern California, La Jolla, CA, September 23-24, 2014.
FDA Enforcement of GCP Requirements: A Review of Key Warning Letters (2010-2012). DIA GCP
QA Community. Webinar. July 24, 2014.
Regulation of Clinical Research in the U.S. Barney & Barney In-house Briefing. July 7, 2014. San
Global Regulatory Considerations in Clinical Trials. National Institutes of Health In-House
Seminar. March 26, 2014. Bethesda, MD.
FDA Enforcement in the Clinical Research Arena. Compliance2Go Webinar. October 30, 2013.
FDA Enforcement in the Clinical Research Arena. ACRP San Diego Chapter. September 19, 2013.
Informed Consent: Promise, Pledge, Contract or Platitude? DIA Annual Conference. June 27, 2013.
Clinical Trials: Regulatory and Privacy Issues. THE BLUEPRINT™ Webinar Legal Series for
Emerging Life Sciences Companies, jointly sponsored by the California Healthcare Institute and
Duane Morris LLP. May 14, 2013.
An Overview of Issued FDA Warning Letters: What Happened and What Can be Learned. ExL
Pharma’s 2nd Quality Oversight of Clinical Vendors Conference. October 18, 2011. Washington, D.C.
Regulatory Challenges in Executing Global Clinical Studies. The Conference Forum’s 2nd Annual
Executing Global Clinical Trials Conference. September 15, 2011, Philadelphia.
Clinical Trial Registries. Association of Clinical Research Professionals Annual Conference. May 3,
2011, Seattle. [AUDIO RECORDING -- click here]
IRB Liability. Association of Clinical Research Professionals Annual Conference. April 30, 2011,
Case Study: The Dying Child and the Newly-Unapproved Drug. Ethics in Clinical Trials Conference.
Leo Intelligence Group. March 3, 2011, San Diego.
Informed Consent – Pledge, Platitude or Contract? DIA Annual Conference, June 16, 2010,
Ethical Issues for Clinical Trials. ACI International Clinical Trials Conference. February 24, 2010,
Clinical Trial Registries. DIA Annual Meeting. June 24, 2009, San Diego.
FDA Enforcement Issues for International Clinical Trials. ACI International Clinical Trials
Conference. February 26, 2009, New York.
Roadmap to Emerging Regions -- Clinical Trials in Developing Countries. ACI International Clinical
Trials Conference. February 26, 2009, New York.
Compliance in Clinical Research. Eighth Annual Pharmaceutical Regulatory Compliance Congress
and Best Practices Forum, November 8, 2007, Washington, D.C.
Guilty Until Proven Innocent: A Look at IRB Liability. ACRP Annual Conference, April 23, 2007,
Informed Consent: Promise, Pledge, Platitude or Contract? RAPS Annual Conference, October 18,
State Regulation of Clinical Trials. 5th National Conference on Managing Legal Risks in Structuring
& Conducting Clinical Trials, American Conference Institute., September 27-29, 2006, Boston.
Sponsor -- CRO-Investigator Relations. 5th National Conference on Managing Legal Risks in
Structuring & Conducting Clinical Trials, American Conference Institute., September 27-29, 2006,
Clinical Trial Registries: Balm or Bane? OCRA/FDA Annual Educational Conference., May 23,
2006, Irvine, CA.
Specific Payments of Other Sorts -- Understanding SPOOS. Clinical Trials – Controlling Costs
Conference, Institute for International Research (IIR), September 28, 2005, Philadelphia.
Specific Payments of Other Sorts – Understanding SPOOS and Clinical Research. DIA Annual
Meeting, June 29, 2005, Washington, DC.
Managing Financial Disclosure in Clinical Trials. West Coast Drug Development Forum:
Challenges in the Development of Therapeutic Products, DIA, October 25-27, 2004, San Francisco,
CA. [no slides]
Study Contracts: Do You Understand What You Just Signed? North Texas Chapter, ACRP, Annual
Education Symposium, October 16, 2004, Dallas, Texas.
How to Negotiate Other Important Contract Terms. 14th International Contracting & Negotiating
Clinical Trials. Strategic Research Institute. September 27-28, 2004, La Jolla, CA.
State Regulation of Clinical Research. Society of Quality Assurance Annual Meeting, Clinical Track,
Washington, D.C., October 2003.
What Every Clinical Director Must Know About FDA Regulatory Compliance. DIA Annual Meeting,
Half-Day Tutorial, June 2003, San Antonio.
Financial Disclosure in Clinical Research. ACRP, San Diego Chapter, January 2003, San Diego.
“Specific Payments of Other Sorts:” Sifting Through the SPOOS. Barnett-Parexel Conference on
Financial Disclosure, Half-day Workshop, November 2002, Philadelphia.
Financial Disclosure Issues in Clinical Research. FDA Regulatory Law Breakfast Briefing, “What You
Need to Know Before Beginning Your Clinical Trial,” October 2002, San Diego.
Indemnification in Clinical Research. DIA Good Clinical Practice Conference, February 2001,
The Institutional Review Board (IRB) and the Clinical Investigator -- Legal/Regulatory Requirements
and Perspectives. FDA/Orange County Regulatory Affairs (OCRA) Discussion Group Annual
Educational Conference, July 2000. Irvine, CA.
||© 2014 Michael A. Swit.
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Contact me @ 760-815-4762
Clinical Research Publications
Good Clinical Practices: A Review of FDA’s Enforcement Activity. A FDANews Publication.
December 2012. For more info, click here..