PRESENTATIONS & PUBLICATIONS |
PRESENTATIONS |
| 2006 |
| SOT Annual Conference, March 2006 |
| Poster
Presentation Pulmonary Biochemical Alterations Induced by Systemic Administration of Nitrogen Mustard Presented by Nabil Elsayed, Ph.D. |
| 2005 |
| RAPS Annual Conference, October 2005 |
| Track Session -
Drugs Preparation for FDA Advisory Panel and Other FDA Meetings Session Leader: Margaret E. Hurley, M.D. Speakers: Igor Cerny, Pharm.D. - CDER/FDA, Robert M. Kirsch, RAC - Serono, Inc. |
| Sunrise Poster
Session Developing Risk Assessment Plans During Clinical Development and Post-Marketing Presented by Dolores R. Massari, M.S., and Margaret E. Hurley, M.D. |
| DIA 41st Annual Meeting, June 2005 |
| Poster
Presentation Understanding Risk Management Plans and Translating the Development Program Results Presented by Susan M. Mondabaugh, Ph.D., and Margaret E. Hurley, M.D.. |
| SOT Annual Conference, March 2005 |
| Poster
Presentation Injury Dynamics Following Sublethal Blast Overpressure Exposures Presented by Nabil Elsayed, Ph.D. |
| 2004 |
| RAPS Annual Conference, October 2004 |
| Track Session -
Drugs What's New with 505(b)(2) Applications Session Leader: Susan M. Mondabaugh, Ph.D. Speakers: Robert Dormer - Hyman, Phelps, McNamara, P.C., Kerstin Franzen - Pfizer, and Margaret E. Hurley, M.D. |
| Interactions with Healthcare Authorities: Creating a Win-Win
Environment Session Leader: Kevin McKenna, AstraZeneca. Speaker: Susan M. Mondabaugh, Ph.D |
| Sunrise Poster
Session CMC Requirements for Herbal Drug Products Presented by Susan M. Mondabaugh, Ph.D. and Jerry J. Kolaitis Registration Patents and Exclusivity for 505(b)(2) Presented by Mark E. Rosengarten, M.A. and Susan M. Mondabaugh, Ph.D. |
| SOT Annual Conference, March 2004 |
| Poster
Presentation Injury Dynamics Following Sublethal Blast Overpressure Exposures Presented by Nabil Elsayed, Ph.D. |
| 2003 |
| RAPS Annual Conference, October 2003 |
Session
Speaker |
Poster Presentation |
DIA 39th Annual Meeting, June 2003 |
| Poster Session CMC Risk-based Product Reviews Presented by Marshall A. Hayward, Ph.D. Finding the Subtle Safety Signal Presented by Margaret E. Hurley, M.D. |
PUBLICATIONS |
| 2006 |
| RAPS Focus Magazine, March 2006 |
The Role of Regulatory Affairs in Due
Diligence for Late-Stage Products |
| 2005 |
| RAPS Focus Magazine, November 2005 |
Are
You Ready for the Risk Management Paradigm Shift? |
| Risk
Management - Translating the Results of the Development Program in Today's Regulatory
Environment By Susan M. Mondabaugh, Ph.D., Dolores R. Massari, M.S., and Margaret E. Hurley, M.D. |
| RAPS Focus Magazine, June 2005 |
How
to Investigate Out-of-Specification Results |
| 2004 |
| RAPS Focus Magazine, October 2004 |
A
Data-Driven CMC Review Process to Minimize Risk |
| RAPS Focus Magazine, May 2004 |
The Nuts and Bolts of
505(b)(2) Applications |
Successfully Navigating the
505(b)(2) Regulatory Maze |
To "(b)(2)" or Not
to "(b)(2)"? When a 505(b)(2) is Not an ANDA |
Are You Protected? Are
You Excluded? Understanding Patent Certification and Exclusivity Incentives for
505(b)(2) NDAs |
| 2002 |
| RAPS Focus Magazine, April 2002 |
| ICH Update: The Common Technical
Document By Susan M. Mondabaugh, Ph.D. |
| One Main Street Chatham, NJ 07928 USA Phone: 1.973.635.9898 Fax: 1.973.635.9881 |
.gif|Digits=5)