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| Drug Development |
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Introduction to Pharmaceuticals, Margaret E. Hurley, M.D., Susan M. Mondabaugh, Ph.D., Presented as a RAPS Webcast May 9, 2007 |
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Global Development Programs: Does Multinational Harmonization Work?, Susan M. Mondabaugh, Ph.D., Presented at RAPS 2003 Annual Conference & Exhibition |
| 505(b)(2) |
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505(b)(2) NDAs and Related Applications, Susan M. Mondabaugh, Ph.D., Robert Dormer, Esq. (Hyman Phelps & McNamara, P.C.), Patricia Anderson, Ph.D. (CanReg Inc.), Presented at the 2009 RAPS Annual Conference & Exhibition |
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Challenges for Global Labeling Parts 1 & 2: New FDA & European Requirements, Margaret E. Hurley, M.D., Tim Cuniff, PharmD (Ovation Pharmaceuticals), Presented at the 2007 DIA Annual Meeting |
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Are You Protected? Are You Excluded? Understanding Patent Certification and Exclusivity Incentives for 505(b)(2) NDAs, Rosengarten MD, Regulatory Affairs Focus, May 2004 |
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Registration Patents and Exclusivity for 505(b)(2), Mark Rosengarten, M.A., Dolores Massari, M.S., Susan Mondabaugh, Ph.D., Presented at the 2004 RAPS Annual Conference & Exhibition |
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Successfully Navigating the 505(b)(2) Regulatory Maze, Mondabaugh SM, Regulatory Affairs Focus, May 2004 |
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The Nuts and Bolts of 505(b(2) Applications, Hurley ME, Regulatory Affairs Focus, May 2004 |
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To “(b)(2)” or Not to “(b)(2)?” When a 505(b)(2) is not an ANDA, Massari DR, Regulatory Affairs Focus, May 2004 |
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What’s New with 505(b)(2) Applications? Current Issues and Trends, Susan M. Mondabaugh, Ph.D., Margaret E. Hurley, M.D., Kerstin Franzén, MSc. Pharm (Pfizer), Robert A. Dormer, Esq. (Hyman Phelps & McNamara, P.C.), Presented at the 2004 RAPS Annual Conference & Exhibition |
| Safety, Risk Management & REMS |
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Cardiac Safety: Regulatory Requirements and Drug Development Timelines, Margaret E. Hurley, M.D., Presented at the 2010 RAPS Annual Conference & Exhibition |
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Cardiac Safety: How Did We Get Here? Susan M. Mondabaugh, Ph.D., Presented at the 2010 RAPS Annual |
| Conference & Exhibit |
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Update on Suicidal Thinking and Behavioral Classification, Margaret E. Hurley, M.D., Kelly Posner, Ph.D. (Columbia University), Presented at the 2006 RAPS Annual Conference & Exhibition |
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Risk Management – Translating the Results of the Development Program in Today’s Regulatory Environment, Mondabaugh SM, Hurley ME, Massari DR, Regulatory Affairs Focus, November 2005 |
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Understanding Risk Management Plans and Translating the Development Program Results, Susan M. Mondabaugh, Ph.D. and Margaret E. Hurley, M.D., Presented at the 2005 DIA Annual Meeting |
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Are you Ready for the Risk Management Paradism Shift? Susan Mondabaugh, Ph.D., Regulatory Affairs Focus November 2005 |
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A Data Driven CMC Review Process to Minimize Risk, Dolores Massari, M.S., Mark Rosengarten, M.A., Margaret E. Hurley, M.D., Susan Mondabaugh, Ph.D., Presented at the 2003 RAPS Annual Conference & Exhibition |
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Finding the Subtle Safety Signal, Margaret E. Hurley, M.D., Presented at the 2003 RAPS Annual Conference & Exhibition |
| CMC |
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CMC Risk-Based Product Reviews, Marshall A. Hayward, Ph.D., Presented at the 2003 RAPS Annual Conference & Exhibition |
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Nanoparticles: What’s the Big Deal? Xiaofeng Meng, Ph.D., Presented at the 2010 RAPS Annual Conference & Exhibition |
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How to Investigate Out-of-Specification Results, Kolaitis JJ, Mondabaugh SM, Regulatory Affairs Focus, June 2005 |
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A Data Driven CMC Review Process to Minimize Risk, Massari DR, Diegnan GA, Hurley ME, Rosengarten ME, Mondabaugh SM, Regulatory Affairs Focus, October 2004 |
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CMC Requirements for Herbal Drug Products, Jerry J. Kolaitis and Susan M. Mondabaugh, Ph.D., Presented at the 2004 RAPS Annual Conference & Exhibition |
| FDA Meetings |
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Stragtegies for Preparing for Meetings with FDA,
Susan Mondabaugh, Ph.D., Presented at The Second Annual FDA |
| Regulatory & Compliance Symposium 2006 |
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Preparation for FDA Advisory Panel and Other FDA Meetings, Margaret E. Hurley, M.D., Presented at The Second Annual FDA Regulatory & Compliance Symposium 2006 |
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