Key Abbreviations
[To view/download the full text of a presentation or article, just click on the title below.]
Product/Corporate Life Cycle -- Strategies & Tactics -- Presentations
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Moderator, Entrepreneur Panel. 11th BVS La Jolla Biotech Day.  Biotech Vendor
Services.  December 11, 2013.  San Diego. [no slides; moderated only] [
Click here for
recording of session]

Creative Strategies in Dealing with FDA.  Compliance2Go. Webinar.  February 21,
2013.

Get to the Clinic on Time. LARTA NIH-CAP Commercialization Workshop,
November 1, 2011. Los Angeles.

Challenges of Orphan Drug Regulation.  The Weinberg Group Inc. Webinar, February
23, 2011.

Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful
Transactions.  The Weinberg Group Inc. Webinar, June 23, 2010.

Regulatory Pitfalls in Drug Development.  American Chemical Society, San Diego
Chapter.  November 18, 2009, San Diego.

Regulatory Update.  Ophthalmic Drug and Delivery Summit. Pharmaceutical
Education Associates.  September 22, 2009, San Diego.

Drug Development.  Moderator, Biotech Vendors Services.  July 22, 2009, San Diego.  
[
moderator; no slides]

Drug Safety.  Orange County Regulatory Affairs (OCRA)/FDA Annual Educational
Conference.  June 10, 2009, Irvine, CA.

Regulatory Developments for Drug Delivery.  Third Annual Drug Delivery Summit.  
Arrowhead Conferences. May 14, 2009, San Francisco.

Drug Safety:  Perspectives on Industry's Duties in the Post-Vioxx Age.  FDLI Annual
Conference.  April 22, 2009, Washington, D.C.

Regulatory Aspects of Ophthalmic Drug Development.  Pharmaceutical Education
Associates Ophthalmic Drug Delivery Conference.  September 22-24, 2008, San Diego

Clearing the US and EU Regulatory Path to Product Approval.  Swedish American
Chamber of Commerce.  Swedish-American Entrepreneurial Days. April 9, 2008, San
Diego.

Keynote Presentation on FDA Regulatory Developments.  Pharmaceutical Education
Associates’ 2nd Annual Skin Summit Conference, February 20, 2008, Philadelphia.

International Drug Development. Pharmaceutical Education Associates Pipeline to
Product Conference, November 30, 2007, Alexandria, VA.

Regulatory Pitfalls in Drug Development. Pharmaceutical Education Associates
Pipeline to Product Conference, November 30, 2007, Alexandria, VA.

Keynote Presentation on FDA Regulatory Developments. Pharmaceutical Education
Associates Annual Nasal Drug Delivery Conference, October 4, 2007, Philadelphia.

FDA Regulatory Developments.  Keynote Presentation at Pharmaceutical Education
Associates Annual Ophthalmic Drug Delivery Conference, September 10, 2007, San
Diego.

Keynote Presentation on FDA Regulatory Developments.  Presented at the  
Pharmaceutical Education Associates Annual Drug Delivery Conference, June 6, 2007,
San Diego.

The Impact of the Democratic Congress on the Biotech Industry.  Moderated Panel at
the BayBio Annual Meeting, April 26, 2007, San Francisco. [
panel; no slides]

Alternative Approaches to Drug/Biologics Approvals.  SDRAN, November 28, 2006,
San Diego.

Strategies in Designing Clinicals for Fixed-Combination Drugs.  DIA Annual Meeting,
June 19, 2006, Philadelphia.

California Stem Cell Research And Cures Act.  RAPS West Coast Conference &
Exhibition, March 22-24, 2005, San Francisco, CA.

Strategies in Designing Clinicals for Fixed-Combination Drugs.  Combination Drug
Development Conference sponsored by Barnett International Conferences, March 7-8,
2005, San Diego, CA.

Financial and Legal Implications of Risk Management: The Broader Picture.  
Developing a Risk Management Strategy: A Hands-On Workshop sponsored by the
Pharmaceutical Education & Research Institute (PERI), November 10-11, 2004,
Washington, DC.

FDA Legal and Regulatory Strategies for Start-up Companies. Tech Coast Angels,
BioMedTrak Program
, March 2003, La Jolla, CA.
Crisis Management
Food & Food Additives
Generic Drugs
Product/Corporate Life Cycle -- Strategies & Tactics -- Articles
Before Merging, Check for FDA Problems. National Law Journal, September 4, 2000,
For information on the Services I
provide relating to FDA issues in
the
Corporate Life Cycle, click here
...
Archives -- Product Lifecycle - Strategy
For information on the Services I
provide relating to FDA issues in
the
Corporate Formation, click here
...
© 2014   Michael A. Swit.  
ALL RIGHTS RESERVED.


Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit