Before Merging, Check for FDA-related Problems, National Law Journal, September 4, 2000, pages B13-B14.
Author, “How Data Integrity Issues Sunk a $4.3 Billion Drug Company Acquisition – Lessons Not Just for Quality Professionals, But Also Their Top Management. Legal Letter from America. GMP Review,. October 2018. Volume 17, No. 3, pp. 18-20.
Due Diligence: The Regulatory, Quality and Clinical Challenges Posed by Transactions Involving Highly-Regulated Biotech Products and Companies. Moderator. 19th Annual FDA-OCRA Educational Conference. May 5, 2016. Irvine. CA. [moderator; no slides]
Legal Aspects of Outsourcing. Outsourcing 101. SDRAN/OCRA Conference. November 19, 2014. Carlsbad, CA.
Quality Aspects of Due Diligence for Biopharmaceutical Transactions. DIA Annual Conference. June 21, 2011, Chicago.
Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful Transactions. The Weinberg Group Inc. Webinar, June 23, 2010.
The Forgotten Keys to Bio-Pharma Transactions -- Regulatory, Clinical & Quality Challenges in Contracting and Due Diligence. Cambridge Healthcare Institute Second Annual Bridging the Business Development-Alliance Management Interface Conference. November 6, 2008, Boston.
How to Negotiate Other Important Contract Terms. 14th International Contracting & Negotiating Clinical Trials. Strategic Research Institute. September 27-28, 2004, La Jolla, CA.
Legal and Regulatory Concerns in the Sourcing of FDA-Regulated Products, Components & Services. Center for Professional Advancement -- In-House Seminar on "Vendor & Supplier Qualification." Siemens, Concord, California. January 2004.
Part 1 – The Impact of FDA Legal & Regulatory Requirements on Device Company Sourcing Activities
Part 2 – The Contract and Related Legal Strategies
Legal Strategies in Sourcing of FDA-Regulated Goods and Services – Seeking a Win-Win Relationship with Your Contract Manufacturing rganization. IBC Conference on “Scale-Up: From Bench to Clinic”, August 2002, San Diego.
Legal and Regulatory Strategies in Sourcing of Products, Components and Services for FDA-Regulated Companies. Biotechnology Industry Organization (BIO) Annual Conference, June 2001, San Diego, CA.
Indemnification in Clinical Research. DIA Good Clinical Practice Conference, February 2001, Tucson, AZ.