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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, Mark E. Rosengarten, M.A., Regulatory Affairs Focus, May 2004 |
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Registration Patents and Exclusivity for 505(b)(2), Mark E. Rosengarten, M.A., Dolores R. Massari, M.S., Susan M. Mondabaugh, Ph.D., Presented at the 2004 RAPS Annual Conference & Exhibition |
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Successfully Navigating the 505(b)(2) Regulatory Maze, Susan M. Mondabaugh, Ph.D., Regulatory Affairs Focus, May 2004 |
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The Nuts and Bolts of 505(b(2) Applications, Margaret E. Hurley, M.D., 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, Dolores R. Massari, M.S., 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 2006 RAPS Annual Conference & Exhibition |
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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, Susan M. Mondabaugh, Ph.D., Margaret E. Hurley, M.D., Dolores R. Massari, M.S., 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 Paradigm Shift? Susan M. Mondabaugh, Ph.D., Regulatory Affairs Focus November 2005 |
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A Data Driven CMC Review Process to Minimize Risk, Dolores R. Massari, M.S., Mark E. Rosengarten, M.A., Margaret E. Hurley, M.D., Susan M. 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 |
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CMC Risk-Based Product Reviews, Marshall A. Hayward, Ph.D., Presented at the 2003 RAPS Annual Conference & Exhibition |
| CMC |
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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, Jerry J. Kolaitis, Susan M. Mondabaugh, Ph.D., Regulatory Affairs Focus, June 2005 |
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A Data Driven CMC Review Process to Minimize Risk, Dolores R. Massari, M.S., Glen A. Diegnan, Ph.D., Margaret E. Hurley, M.D., Mark E. Rosengarten, M.A., Susan M. Mondabaugh, Ph.D., 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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Strategies for Preparing for Meetings with FDA, Susan M. 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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