Archives -- Clinical Research

Publications

Good Clinical Practices:  A Review of FDA’s Enforcement Activity.  A Detailed Management Report. FDANews.Com.  January 2013. 

Presentations

GCP Enforcement Trends: Lessons Learned from FDA Inspections of Sponsors, Sites and IRBs.  A FDANews.com Webinar.  July 21, 2015. 


The Small Company Clinical Study Sponsor -- Roles & Duties Vis-à-vis Liability.  Outscourcing in Clinical Trials:  Southern California.  Arena Conferences.  September 24, 2014.  San Diego.


FDA Enforcement in the Clinical Research Setting.  Webinar sponsored by the Drug Information Association (DIA) GCP/QA Community.  July 24, 2014.


Clinical Studies -- An Overview of FDA Regulation.  Barney & Barney In-House Presentation.  July 7, 2014. San Diego.


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.  San Diego.


Informed Consent:  Promise, Pledge, Contract or Platitude?  DIA Annual Conference.  June 27,  2013. Boston.


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:  Panacea or Pablum?  Association of Clinical Research Professionals Annual Conference.  May 3, 2011, Seattle.  [AUDIO RECORDING -- click here]


Guilty 'Til Proven Innocent: A Look at IRB Liability.  Association of Clinical Research Professionals Annual Conference.  April 30, 2011,  Seattle.  


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, Washington, D.C.  

Ethics in Clinical Trials -- the Key Role of Informed Consent.  ACI International Clinical Trials Conference. February 24, 2010, New York.  


Clinical Trial Registries.  DIA Annual Meeting. June 24, 2009, San Diego.  


Ensuring FDA Compliance in 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.  


Clinical Trial Registries.  University of Southern California Regulatory Affairs Masters Program. July 27, 2007.  Irvine, CA.


Guilty Until Proven Innocent: A Look at IRB Liability.  ACRP Annual Conference, April 23, 2007, Seattle.  


INFORMED CONSENT:  Pledge, Promise, Contract or Platitude?  Key Aspects of Informed Consent for the Regulatory Professional?  RAPS Annual Conference, October 18, 2006, Baltimore.  


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.  


Managing Sponsor/Investigator Relationships.  5th National Conference on Managing Legal Risks in Structuring & Conducting Clinical Trials, American Conference Institute., September 27-29, 2006, Boston.  


Clinical Trial Registries & Databases: An Update.  OCRA/FDA Annual Educational Conference., May 23, 2006, Irvine, CA.  


Impact of Significant Payments of Other Sorts (SPOOS) on Clinical Research.  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]  


Clinical 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 – Duties and Strategies for Clinical Studies. 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, Tucson, AZ.  


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. 

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