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Brand/Generic Drug Regulatory and Competition -- Presentations
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| Speeches & Articles Archives |
Brand/Generic Drug Regulatory and Competition -- Articles
Update on Generic Biologics. RAPS Focus 12(2), 30-35, 2007.
Hurdles on the Scientific Path to a Biogeneric Approval. RAPS Focus 10(3):43-46,
2005.
Getting Your Generic Drug Approved. Washington Business Information, Inc.,
Editor, 1995.
Hurdles on the Scientific Path to a Biogeneric Approval. RAPS Focus 10(3):43-46,
2005.
Getting Your Generic Drug Approved. Washington Business Information, Inc.,
Editor, 1995.
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Regulation of Generic, OTC and Orphan Drugs, and Cosmetics. Lecture at SDRAN
RAC Review Course. July 27, 2011, San Diego.
BioSimilars. Orange County Regulatory Affairs Discussion Group/FDA Annual
Educational Conference. June 9, 2011, Irvine, CA.
BioSimilars. RAPS Annual Conference. October 25, 2010, San Jose, CA.
BioSimilars. Foley & Lardner Life Sciences Day. September 30, 2009, San Diego,
CA.
Course on Generic Drug Approvals. In-House at Teva Parenterals. September 1 and
2, 2009, Irvine, CA. Three presentations: (1) Introduction to Generic Drug Law (2)
Basics of Waxman-Hatch (3) Bioequivalence
Update on Generic Drugs and BioSimilars Orange County Regulatory Affairs
Discussion Group/FDA Annual Educational Conference. June 2009, Irvine, CA.
The Future of BioSimilars, BioGenerics, Follow-on Biologics – A Rose by any Other
Name? New York Biotechnology Association Annual Meeting. April 21, 2009, New
York.
Panel Discussion on Generic Biologics. Licensing Executives Society, San Diego
Chapter. May 20, 2008, San Diego. [panel; no slides]
Panel Discussion on Generic Biologics. FDLI Annual Conference, April 12, 2007,
Bethesda, MD. [panel; no slides]
Lifecycle Management for Pharmaceutical Companies: A Generic Perspective. RAPS
Horizons Conference, March 29, 2007, San Francisco.
Non-Patent Market Exclusivity for Pharmaceuticals Under the Drug Price
Competition and Patent Term Restoration Act of 1984 ("Waxman-Hatch"). San
Diego County Bar Association, IP Section, March 19, 2007, San Diego.
Abbreviated New Drug Applications. FDLI Introduction to Biotechnology
Conference, June 14-15, 2005, San Francisco, CA.
Case Study: The Generic Drug Scandal. Ethics in Regulatory Affairs, OCRA,
August 30, 2004, Irvine, CA.
Recent Developments in Generic and OTC Drug Regulation. OCRA/FDA, June 2003
Annual Joint Educational Conference, Irvine, CA.
Challenges to Generic Drug Approvals. IBC Generic Drug Conference, September
1999, Washington, D.C.
RAC Review Course. July 27, 2011, San Diego.
BioSimilars. Orange County Regulatory Affairs Discussion Group/FDA Annual
Educational Conference. June 9, 2011, Irvine, CA.
BioSimilars. RAPS Annual Conference. October 25, 2010, San Jose, CA.
BioSimilars. Foley & Lardner Life Sciences Day. September 30, 2009, San Diego,
CA.
Course on Generic Drug Approvals. In-House at Teva Parenterals. September 1 and
2, 2009, Irvine, CA. Three presentations: (1) Introduction to Generic Drug Law (2)
Basics of Waxman-Hatch (3) Bioequivalence
Update on Generic Drugs and BioSimilars Orange County Regulatory Affairs
Discussion Group/FDA Annual Educational Conference. June 2009, Irvine, CA.
The Future of BioSimilars, BioGenerics, Follow-on Biologics – A Rose by any Other
Name? New York Biotechnology Association Annual Meeting. April 21, 2009, New
York.
Panel Discussion on Generic Biologics. Licensing Executives Society, San Diego
Chapter. May 20, 2008, San Diego. [panel; no slides]
Panel Discussion on Generic Biologics. FDLI Annual Conference, April 12, 2007,
Bethesda, MD. [panel; no slides]
Lifecycle Management for Pharmaceutical Companies: A Generic Perspective. RAPS
Horizons Conference, March 29, 2007, San Francisco.
Non-Patent Market Exclusivity for Pharmaceuticals Under the Drug Price
Competition and Patent Term Restoration Act of 1984 ("Waxman-Hatch"). San
Diego County Bar Association, IP Section, March 19, 2007, San Diego.
Abbreviated New Drug Applications. FDLI Introduction to Biotechnology
Conference, June 14-15, 2005, San Francisco, CA.
Case Study: The Generic Drug Scandal. Ethics in Regulatory Affairs, OCRA,
August 30, 2004, Irvine, CA.
Recent Developments in Generic and OTC Drug Regulation. OCRA/FDA, June 2003
Annual Joint Educational Conference, Irvine, CA.
Challenges to Generic Drug Approvals. IBC Generic Drug Conference, September
1999, Washington, D.C.