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Publications, Presentations, Courses Given, Webinars

   TEXTBOOKS:

    1. Pharmacovigilance from A to Z-Adverse Drug Event Surveillance.  Barton Cobert & Pierre Biron.  Blackwell 2001

     2. Manual of Drug Safety and Pharmacovigilance 1st edition. Barton Cobert. J&B Publications  2007

     3. Practical Drug Safety from A to Z. Barton Cobert and Pierre Biron. J&B Publications  2008

     4. 100 Questions & Answers About Your Child's Obesity. Barton and Josiane Cobert. J&B Publications 2009

     5. Drug Safety Data: How to Analyze, Summarize, and Interpret to Determine Risk. Michael Klepper & Barton        Cobert. J&B Learning 2010

     6. Cobert's Manual of Drug Safety & Pharmacovigilance 2nd edition. Barton Cobert. J&B Learning 2011

 

   PUBLICATIONS:

 1.   Hermansky-Pudlak Syndrome and Granulomatous Colitis. Annals of Internal Medicine 1980; 92:20

 2.   Additive Effects of Inducers and Fasting on Acetaminophen Hepatotoxicity.Biochemical Pharmacology 1980; 29:2219

 3.   Self-Induction by Triacetyloleandomycin of its own Transformation into a Metabolite Forming a Stable 456 nm Absorbing Complex with Cytochrome P-450. Biochemical Pharmacology 1981; 30:553

 4.   Hypoactivity of Cytochrome P-450 after Triacetyloleandomycin Administration. Biochemical Pharmacology 1981; 30:559

 5.   Hepatotoxicity of Trichloroethylene-Carbon Tetrachloride Mixtures in Rats. Gastroenterology 1982; 83:761

 6.   Failure of Trimipramine as an Antisecretory, Antiulcer Agent in the Rat (Abstract). Gastroenterology 1983; 84:1171

             7.   Pentoxifylline in Acute Nonhemorrhagic Stroke. Stroke 1988; 19:716

 8.   Efficacy and Safety of Pentoxifylline in Geriatric Patients with Intermittent Claudication.  Angiology 1989; 40:795

 9.   Effects on Sleep: A Double-Blind Study Comparing Trimipramine to Imipramine in Depressed Insomniac Patients.  Sleep 1989; 12:537

 10.  Dose-Response Effects of Pentoxifylline on Erythrocyte Filterability. Clin Pharmacol Ther 1990; 48:50

 11. A Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of Nocturnal Roxatidine in the Treatment of Active Duodenal Ulcer Disease.  American Journal of Gastroenterology 1992; 87:847

 12. A Multicenter, Randomized, Double-Blind Comparison of Roxatidine with Ranitidine in the Treatment of Patients with Uncomplicated Benign Gastric Ulcer Disease. Clinical Therapeutics 1995; 17:467

 13. A Template for Adverse Event Reporting in Licensing Agreements. Drug Information Journal 1996; 30:965

 14. The Internet, Adverse Events and Safety. International Journal of Pharmaceutical Medicine 1998; 12:83

 15.  The CIOMS III Criteria for Labeling Changes. A Survey at Schering-Plough. Drug Information Journal 1998; 32:1149

 16. The Internet and Drug Safety: What are the Implications for Pharmacovigilance. Drug Safety 1999 20(2): 95

 17.  Cardiovascular Profile of Loratadine. Clinical and Experimental Allergy 1999 Jul;29(S3):197-199

 18.  Drug Safety.  A Contrarian’s Point of View.  Food Drug & Law Journal 2007 Aug; 62:3:501-512

  19.  FDA Drug Safety Bill: How Safe are our Drugs?  Expert Opinion in Drug Safety 2008 Aug; 7(4): 345

 20. Drug Safety Registries: Are they useful? Chinese J of Clinical Pharmacology & Therapeutics (in Chinese) Jan 2009

 21.  Taking a proactive approach to product recalls and withdrawals.  Regulatory Affairs J Pharma.  February, 19 2011

   

TRAINING COURSES GIVEN AS INSTRUCTOR:

             DIA Training Session, How to Survive a Drug Safety Inspection. Horsham, PA. August 4, 2009.

             .  DIA Training Session, How to Survive a Drug Safety Inspection. Horsham, PA. December 7, 2009.

             .  DIA Training Session, Introduction to Clinical Trial Pharmacovigilance. Horsham, PA. Feb 16-17, 2010.

             .  DIA Training Session, Introduction to Post-Marketing Pharmacovigilance. Horsham, PA. Feb 18-19, 2010.

             .  The Foresight Group: PV University: PV & Drug Safety Inspections. Livingston, NJ. Feb. 19, 2010.

             Health Canada (Government): PSUR Training. Ottawa, Canada. March 8-11, 2010.

             .  DIA Training Session, How to Survive a Drug Safety Inspection.  Horsham, PA. May 6, 2010.

             .  DIA Training Session, How to Survive a Drug Safety Inspection.  DIA Annual Meeting, Washington DC. June 13, 2010

             DIA Training Session, How to Survive a Drug Safety Inspection.  Horsham, PA. October 15, 2010

             .  DIA Training Session, “Pre-Approval & Post-Approval Drug Safety & PV” Horsham, PA, November 15-18, 2010.

             .  DIA Training Session, How to Survive a Drug Safety Inspection.  DIA Annual Pharmacovigilance Meeting, Washington DC. January 9-12, 2011.

             .   DIA Training Session, “Pre-Approval & Post-Approval Drug Safety & PV” Horsham, PA, March 21-24, 2011.

             .   Drug Safety Research Unit Changing Global Regulatory PV Environment -The US Perspective - How to Satisfy the FDA. London, UK May 18, 2011

 DIA Training Session, “Pre-Approval & Post-Approval Drug Safety & PV” Horsham, PA
October 2011
March 2012
August 2012



PRESENTATIONS:

                .     Presenter, Financial Implications for Drug Safety & PV, DIA Annual Meeting, San Diego, CA.  June 23,    
                      2009.
     

.      Presenter, Risk Management: Update from the US. University of Montreal Therapeutic Risk Management Conference, Montreal, Canada. June 4, 2009.

 .     Presenter, Annual Update Your Dermatology, Tufts New England Medical Center, Drug Safety & China, Boston, MA. November 1, 2008.

 .     Session Chair, Annual DIA Meeting: Source Systems and Maintaining Data Integrity in Clinical Research, Boston, MA. June 25, 2008. 

 .     Presenter, Neurology Department Conference, Brigham & Women’s Hospital: Update on Drug Safety. Boston, MA June 24, 2008. 

 .     Presenter, Annual DIA Conference and Exhibition: Data Management in Transition: Annual DIA Conference and Exhibition: The FDA Revitalization Act, Drug Safety and Data Management”, Washington, DC. March 18, 2008.

 .     Presenter, Chinese Food & Drug Administration (SFDA) training session, “Current Practice of Drug Safety”, “Inspection Best Practices”, “Drug Safety Surveillance”, “Risk Management – Review of a Product”, Sanya, China Dec 15-19, 2007.

 .     Presenter, DIA Canada Annual Meeting “Where is drug safety going?” Montreal, Canada October 28, 2007.

 .     Presenter, DIA Annual Meeting “Lessons Learned in the World of Security as it Relates to Computerized Clinical Systems” (substitute speaker for Dr. Nelson Kopyt), Atlanta, GA June 21, 2007.  

 .     Presenter, DIA Canada Annual Meeting “Industry’s Perspective on Spontaneous AEs & PSUR Data”, Ottawa, Canada October 30, 2006. 

 .     Presenter, Interactive Web Conference (Webseminar), “International Drug Safety and Risk Management”, Barnett Educational Services, October 11, 2005.

  .     Presenter, DIA Canada Annual Meeting “Pharmacovigilance: Great Expectations or Bleak House? Montreal, Canada  September 25, 2005. 

.     Presenter, “Drug and Device Safety Summit” Topic: Defining Risk and the Limitations of Risk Management.  Barnett International Conference. Philadelphia, PA. May 2-3, 2005.

.     Presenter, Montreal Pharmacovigilance Forum. Topic: Pharmacovigilance.  Where is it going?  Montreal, Canada. May 19, 2004.

  .     Guest Lecturer, “Pharmacovigilance Post-Graduate Course” Topic: Adverse event reporting in the pharmaceutical industry. (Lecture given in the French language). “Université de Montréal, Canada. November 19, 2001. 

 .     Presenter, “Adverse event reporting: avoiding and solving problems” The Applied Clinical Trials European Summit. Advanstar Communications, Paris, France May 14-15, 2001.

  .     Presenter, “Transitioning to MedDRA from a Global and a Corporate Perspective” Institute for International Research, Arlington, VA. July 27 and 28, 2000.

 .     Presenter, “When does a Safety Signal Trigger a Label Change?”  Pharmaceutical Education & Research Institute (PERI), Philadelphia, April 10, 2000.

 .     Chair and Presenter, “Overcoming the Practical Pproblems of Carrying Out Effective Pharmacovigilance in a Global Licensing Agreement.”  IIR Limited, London, January 24-25, 2000.

  .     Guest Lecturer, "Pharmacovigilance Post-Graduate Course” Topic: Adverse Event Reporting & MedDRA. (Lecture given in the French language). "Université de Montréal, Canada. October 5, 1999. 

 .     Presenter & Panelist, “Complying with International Regulatory Requirements for the Provision of Product Information” IIR Limited, London, September 22-23, 1999.

 .     Presenter & Panelist, “Improvements in Pharmacovigilance Communication – The Internet,” The WHO Anniversary Symposium on The current State of Pharmacovigilance – A Critical Examination.  Stockholm, December 9-11, 1998. 

 .     Presenter, “Understanding and Meeting FDA Requirements for Successful AE/ADR Reporting in the USA”, IIR Limited, London, September 15-16, 1998.

 .     Chair and Presenter, “Examining the Role of the Internet in Collection Adverse Drug Reaction Data and the Implications for Pharmaceutical Companies. IBC UK Conferences, London, May 18-19, 1998.

  .     Presenter, “Use of the Internet for Safety Data and Surveillance.”  Pharmacovigilance: Information Highway Tools for Adverse Drug Reactions (ADRs). CODATA/European Society of Pharmacovigilance Meeting, Chambery, France April 20-21, 1998.

 .     Presenter, “La Pharmacovigilance des Antihistaminiques” (Presentation done in French), Schering Plough France Antihistamine-Allergy Meeting, Kenilworth, NJ, March 10, 1998.

  .     Presenter, “Successfully Meeting Reporting Regulations for ADRs in Europe” Topic: Understanding and meeting the requirements of the FDA to ensure successful adverse event/ADR reporting in the USA”. Institute for International Research, London, February 9 and 10, 1998.

 .     Presenter, “Successfully Meeting Reporting Regulations for ADRs in Europe  Topic: Understanding and meeting the requirements of the FDA to ensure successful adverse event/ADR reporting in the USA”. Institute for International Research, London, November 24 and 25, 1997.

     Presenter, “The Internet and Pharmacovigilance” Fifth Annual Meeting of the European Society of Pharmacovigilance. Berlin, Germany. September 15, 1997.

  .     Chair and Presenter, “Regulatory Reporting Requirements for Adverse Drug Reactions & Adverse Events”: Topic: Examining the role of the Internet in Collecting Adverse Event Information and the Implications for Pharmaceutical Companies. IBC UK Conferences, London, September 11 and 12, 1997.

 .     Presenter and Roundtable Participant, “Preserving Clinical Trial Ethics” Topic: Outsourcing, Safety and Ethics: Privacy Issues. Institute for International Research, Washington, D.C, July 28, 1997.

 .     Presenter, “Successfully Meeting Reporting Regulations for ADRs”  Topic: Understanding and meeting the requirements of the FDA to ensure successful adverse event/ADR reporting in the USA”. Institute for International Research, London, June 11 & 12, 1997.

 .     Presenter, “Adverse Drug Reaction Reporting” Topic: Incorporating AE Reporting into Licensing Deals. Institute for International Research, Washington, D.C., March 6, 1997.

 .     Presenter, “Regulatory Reporting Requirements for Adverse Drug Reactions Throughout Europe” Topic: The Role of the Internet in Collecting Adverse Event Information and the Reporting Implications. IBC Technical Services, London, December 11 & 12, 1996.

 .     Presenter, “Adverse Drug Reaction Reporting,” Topic: Incorporating AE Reporting into Licensing Deals. Institute for International Research Inc., Philadelphia, October 8 & 9, 1996.

  .     Presenter, “A US Industry View of Pharmacovigilance in Europe,” Drug Information Association (DIA) Annual Meeting, San Diego, June 12, 1996.

  .     Presenter, “Adverse Events ‘96”Collecting,” Topic: Reengineering & Implementing a Worldwide Adverse Event Reporting System. Barnett International Inc., Philadelphia, May 9 & 10, 1996.

 .     Presenter, “Collecting, Managing and Presenting ADR Information to Effectively Meet Reporting Regulations in Europe” Topic: One Company’s Experience with Re-engineering.  IIR Ltd. London, Feb. 5 & 6, 1996.

  .     Presenter, Collecting, “Meeting Global Regulatory Requirements for Adverse Drug Reaction Reporting” Topic: How to Handle AE Reporting When Setting Up Licensing Deals. IIR Ltd. Washington, Oct. 18-20, 1995.

 .     Presenter, “Collecting, Managing and Presenting ADR Information to Effectively Meet Reporting Regulations in Europe” Topic: ADR Reporting in the US-Learning from the US Experience.  IIR Ltd. London, Sept. 4 & 5, 1995.

 .       Presenter, DIA Meeting on Harmonization of Worldwide Pharmaceutical Labelling. Topic: “The OTA Report on Labeling.” Arlington, VA., September 10-11, 1992.

  .        Presenter, DIA Meeting on Global Compliance Perspectives of Good Clinical Practice on Clinical Research. Topic: "Update on the International Harmonization Meeting." Philadelphia, November 18 - 20, 1991.

 .     Presenter & Roundtable Participant, First Meeting of the International Committee on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Meeting.  Topic: "Approaches to Harmonization: Good Clinical Practices"  Brussels November 5 - 7, 1991.

 .     Presenter, The Blood Bank Groningen-Drenthe Symposium on Blood Transfusion - "Beta Thromboglobulin - A Story of Value?" Groningen, Holland 1981.

 .     Presenter, New York University School of Medicine, Advances in Gastroenterology Course - "The Small Bowel Biopsy in Clinical Practice" New York 1979

 .     Presenter, DIA Canada Annual Meeting "REMS in the US" Ottawa, Canada. November 3, 2009


WEBINARs:

.     Presenter, Webinar: "FDA Pharmacovigilance 2010: New Initiatives & Compliance Matters". Apcer Pharma Solutions. October 15, 2009.

.     Presenter, Webinar: " Drug Safety Survival: Two or three critical documents you must prepare and have ready to make your drug safety department ‘audit-proof’" FOI Services Webinars. September 13, 2010

.     Presenter, Webinar: " A Drug Recall Case Study: Lessons Learned from a Widespread Drug Recall at a Major Pharmaceutical Company. Thompson Interactive Webinars. September 14, 2010

.    Presenter, Webinar: "FDA Pharmacovigilance 2010: New Initiatives & Compliance Matters". Thompson Interactive Webinars. October 15, 2010

.    Presenter, Webinar: "FDA Compliance for Drug Recalls & Withdrawals" FOI Services Webinars. October 21, 2010

.    Presenter, Webinar: "Drug Safety: What you don’t know can hurt you” " Pharmalot Webinars. November 17, 2010

.    Presenter, Webinar: “SOPs and Drug Safety” FOI Services Webinars. March 17, 2011

.    Presenter, Webinar DIA: How to survive a drug safety audit/inspection. April 2012

                .    Presenter, Webinar FOI Services: The new EU safety regulations. August 2012

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