 | |  | |  | |  | |  | |  | |  |
[To view/download the full text of a presentation or article, just click on the title below.]
Drugs & Biologics --Presentations
| To Jump To Another Page of Our Archives, Just Click on The Subject Button Below ... |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
| |
 |
Drugs & Biologics -- Articles
| For information on the Services we provide relating to FDA issues concerning Drugs & Biologics, click here ... |
| Speeches & Articles Archives |
Biosimilars -- Wave of the Future or Child of The Privileged Few? Licensing Executives Society
San Diego Chapter. February 21, 2012.
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.
Drug Development in Today's Regulatory Environment. NanoTecNexus Webinar. March 4, 2010.
Regulatory Pitfalls in Drug Development. American Chemical Society, San Diego Chapter.
November 18, 2009, San Diego.
Drug Safety. SDRAN/OCRA Drug Development Conference. November 4, 2009, Carlsbad, CA.
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. [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.
FDA Legal and Regulatory Strategies for Start-up Companies. Tech Coast Angels, BioMedTrak
Program, March 2003, La Jolla, CA.
San Diego Chapter. February 21, 2012.
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.
Drug Development in Today's Regulatory Environment. NanoTecNexus Webinar. March 4, 2010.
Regulatory Pitfalls in Drug Development. American Chemical Society, San Diego Chapter.
November 18, 2009, San Diego.
Drug Safety. SDRAN/OCRA Drug Development Conference. November 4, 2009, Carlsbad, CA.
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. [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.
FDA Legal and Regulatory Strategies for Start-up Companies. Tech Coast Angels, BioMedTrak
Program, March 2003, La Jolla, CA.
FDAAA – An Abbreviation in Search of Understanding: A Review of Selected Drugs and
Biologics Provisions of the Food and Drug Administration Amendments Act of 2007. RAPS
Focus 13(2), 27-33, 2008.
Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial
Speech, Drug Delivery Technology, July 2002.
Electronic Signatures Act – Feast or Famine for FDA-Regulated Industries? Swit, M and Edson,
J. FDLI Update, January 2001.
Profitability, Patient Populations and the Orphan Drug Act – or – “Should an Orphan Have
the Right to More Than One Parent?” Food, Drug, Cosmetic and Medical Device Law Digest,
New York State Bar Association, Food, Drug and Cosmetic Law Section, January 1992.
Biologics Provisions of the Food and Drug Administration Amendments Act of 2007. RAPS
Focus 13(2), 27-33, 2008.
Western States Medical Center – Supreme Court Reins FDA in on Regulating Commercial
Speech, Drug Delivery Technology, July 2002.
Electronic Signatures Act – Feast or Famine for FDA-Regulated Industries? Swit, M and Edson,
J. FDLI Update, January 2001.
Profitability, Patient Populations and the Orphan Drug Act – or – “Should an Orphan Have
the Right to More Than One Parent?” Food, Drug, Cosmetic and Medical Device Law Digest,
New York State Bar Association, Food, Drug and Cosmetic Law Section, January 1992.
| ||||||||||||||||||||||||
|