Archives -- Outsourcing & Contracting
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Outsourcing & Contracting Presentations
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Contract Terms for Clinical Trials, North Texas Chapter, ACRP October 16, 2004,
Dallas, Texas.
Crisis Management
Food & Food Additives
Generic Drugs
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 Organization. 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.
Outsourcing & Contracting Articles
Before Merging, Check for FDA Problems, National Law Journal, September 4,
2000, pages B13-B14.
For information on the Services I
provide relating to
Outsourcing &
Legal Aspects of Outsourcing for Drug and Device Companies.  Outsourcing 101
Conference.  Jointly Sponsored by OCRA and SDRAN.  November 19.  San Diego.

Regulatory, Clinical and Quality Challenges in Contracting and Due Diligence: The
Forgotten Keys to Biopharma Transactions.  
DIA Annual Conference. June 2013.
[Moderator;
no slides]

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.
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mswit@fdacounsel.com
Michael A. Swit