Event - Fall Tech 2017
Welcome and Introduction
Robert Femia, PhD, Senior Vice President, Science, Chemical Medicines, USP
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Analytical Procedure Lifecycle and Statistics: Applied to Analytical Procedures/General Chapters
Horacio Pappa, PhD, CQE, Director, Compendial Science-General Chapters, USP
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Elemental Impurities
Horacio Pappa, PhD, CQE, Director, Compendial Science-General Chapters, USP
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Research and Innovation Activities
Mike Ambrose, PhD, Director, Research & Innovation, USP
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Closing Remarks
Nelufar Mohajeri, MA, MPhil, Senior Director, Global Stakeholder Engagement, USP
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State of OGD Address
Kathleen Uhl, MD, Director, Office of Generic Drugs (OGD), FDA
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State of OPQ Address
Giuseppe Randazzo, MS, Director, Office of Program and Regulatory Operations (OPRO) Office of Pharmaceutical Quality (OPQ), FDA
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State of ORA Address
Ellen Morrison, Assistant Commissioner, Medical Products and Tobacco Operations Office of Regulatory Affairs (ORA), FDA
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International Harmonization – IGBA Perspective
Nicholas Cappuccino, Jr., PhD, Vice-President, Head of Quality and Scientific Affairs, Dr. Reddy’s Laboratories, Inc., Chair, Science Committee IGBA
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International Harmonization – IGBA Perspective
Sergio Napolitano, LLM, Legal and External Relations Director, Medicines for Europe
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GDUFA II Pre – ANDA Program
Robert Lionberger, PhD, Director, Office of Research Standards (ORS), OGD, FDA
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GDUFA II Pre – ANDA Program
Kris Andre, MS, Associate Director, Regulatory Affairs, ORS, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements (Part I)
CDR Kwadwo (Kojo) Awuah, PharmD, RAC, Team Leader, Division of Filing Review, Office of Regulatory Operations (ORO), OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
LT Nicholas Daniel, PharmD, BCPS, Regulatory Project Manager, DPM, ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
Michael Folkendt, MS, Associate Director for Regulatory Affairs, OPRO, OPQ, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
Tiffany Houser, PharmD, Regulatory Project Manager, Division of Project Management (DPM), ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
LCDR Andrew Kim, PharmD, Supervisory Project Manager, DPM, ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
Heidi Lee, PharmD, Project Manager, Immediate Office (IO), ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
CDR Vincent Sansone, PharmD, CPH, Deputy Director (Acting), ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
Priya Shah, PharmD, Project Manager, IO, ORO, OGD, FDA
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Office of Generic Drugs GDUFA II Review Program Enhancements
Edward Sherwood, BA, Director, ORO, OGD, FDA
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Anatomy of an Expedited/Priority Review
Kurt Karst, JD, Director, Hyman, Phelps & McNamara, P.C.
Scott Tomsky, MS, BS, Vice President, Regulatory Affairs, Generics North America, Teva Pharmaceuticals
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Data Integrity Issues in Today’s Complex and Global Manufacturing Supply Chain
Derek Smith, PhD, Branch Chief (Acting), Division of Inspectional Assessment
Office of Process and Facility (OPF), OPQ, FDA
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Data Integrity Issues in Today’s Complex and Global Manufacturing Supply Chain
Frances Zipp, President & CEO, Lachman Consultant Services, Inc.
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Update – Implementation of GDUFA II User Fees
Donal Parks, MBA, MPM, Director, Division of User Fee Management and Budget Formulation Office of Management, FDA
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GDUFA II Implementation – Industry Negotiators Perspective on the First Month
Marcy Macdonald, RAC, Vice President, Regulatory Affairs, Impax Laboratories
Kiran Krishnan, PhD, Senior Vice President, Global Regulatory Affairs, Apotex Corp.
Lisa Parks, RPh, Vice President, Sciences & Regulatory Affairs, AAM
Molly Rapp, Vice President, Regulatory Affairs, US Innovation and Development, Generics and Standard Solutions, Fresenius Kabi USA, LLC
Scott Tomsky, MS, BS, Vice President, Regulatory Affairs, Generics North America, Teva Pharmaceuticals
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Highlights from FDA-USP Workshop on Excipients
John Giannone, Senior Director, Excipients, Strategic Marketing and Program Operations, USP
Catherine Sheehan, MS, Senior Director, Science-Excipients, USP
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The Path to Bioequivalence – Great Progress, Great Opportunities
Charles DiLiberti, President, Montclair Bioequivalence Services, LLC
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Complexity of Retention Samples Selection in Non-Traditional Bioequivalence Studies
Nageshwar Thudi, PhD, Director, Clinical Research and Development, Teva Pharmaceuticals
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Drug Product Quality and the Impact of Extractables and Leachables
Diane Paskiet, MS, Senior Director, Global Scientific Affairs, West Pharmaceuticals
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Drug Product Quality and the Impact of Extractables and Leachables
Andrea Redd, BS, Director, US Regulatory Affairs, Fresenius Kabi USA, LLC
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Improving Timeliness of ANDA Approval – A CDMO Perspective
L. Lee Karras, Chief Executive Officer, Halo Pharmaceutical
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Improving Timeliness of ANDA Approval – A CDMO Perspective
Karunakar Sukuru, RPh, PhD, Vice President, Product Development (US&EU), Softgel Technologies, Catalent Pharma Solutions
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Drug Product Market Supply – Compliance and Challenges
Lara Hansen, Associate Director, Regulatory Affairs, Sandoz Inc.
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