Archives -- Product Lifecycle & Strategy

Articles

Before Merging, Check for FDA-related Problems, National Law Journal, September 4, 2000, pages B13-B14.

Presentations & Panel Discussions

 

Ensuring  FDA Success for Biomedical Companies -- Key Lessons for Start-Ups.  Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the  Small Business Development Center (SBDC) at UCI Applied Innovation. October 25, 2018.  Irvine, California. 


Alternative Approaches to FDA Approval for Drug and Device Firms. Joint Orange County Regulatory Affairs (OCRA)/FDA Annual Educational Conference. May 6, 2016. Irvine, CA. 


Alternative Approaches to FDA Approval for Drug and Device Firms. San Diego Regulatory Affairs Network. February 12, 2015. 


Alternative Approaches to FDA Approval for Drug and Device Firms. A Compliance2Go Webinar. January 29, 2015. 


Entrepreneur Panel. Moderator.11th BVS La Jolla Biotech Day.  Biotech Vendor Services.  December 11, 2013.  San Diego. [no slides; moderated only] [Click here for video recording of session]


Creative Strategies in Dealing with FDA for Approval of Drugs and Medical Devices.  PSC Creative Learning Webinar. July 10, 2013. 


Alternative Approaches to FDA Approval for Drug and Device Firms.  Compliance2Go Webinar. February 21, 2013. 


Leaping the Valley of Death: Keys to Successfully Going From the Lab to the Clinic for Pharmaceutical Products. Moderator.  Drug nformation Association (DIA) Annual Conference, Session Chair.  June 26, 2012. Philadelphia. [no slides; moderated panel] 


Regulatory Considerations in Product Development. LARTA NIH-CAP Commercialization Workshop, November 1, 2011. Los Angeles. 


Orphan Drugs – the Challenges and Benefits of Navigating FDA’s Regime Governing Therapies for Rare Diseases. The Weinberg Group Inc. Webinar, February 23, 2011. 

 

Drug Development in Today's Regulatory Environment.  NanoTecNexus Webinar.  March 4, 2010.  


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


Selected Regulatory Issues in Ophthalmic Drug Development.  5th Annual 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]


The Top Ten Ways to Ensure Successful FDA Meetings.  Webinar. The Weinberg Group. March 2, 2009.


FDA Regulatory Issues and  Ophthalmic Drug Development.   Pharmaceutical Education Associates Ophthalmic Drug Delivery Conference. September 22-24, 2008, San Diego.


FDA Regulatory Considerations for  Life Sciences Companies.  Swedish American Chamber of Commerce. Swedish-American Entrepreneurial Days. April 9, 2008, San Diego.


The Regulatory Horizon.  Keynote presentation at the Pharmaceutical Education Associates’ 2nd Annual Skin Summit Conference, February 20, 2008, Philadelphia.

 

Key Current Issues In European Regulation.   Pharmaceutical Education Associates Pipeline to Product Conference, November 30, 2007, Alexandria, VA.  


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


The Regulatory Horizon.  Keynote Presentation on FDA Regulatory Developments at 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.
 

Alternative Approaches to FDA Approval for Drug and Device Firms.  SDRAN, November 28, 2006, San Diego. 


FDA Legal and Regulatory Strategies for Start-up Companies. Tech Coast Angels, BioMedTrak Program, March 2003, La Jolla, CA.  


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