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RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003

RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003

Regulation of Medical Devices Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Food and Drug Administration. RHAIR Society for Academic Emergency Medicine Boston, Massachusetts May 31, 2003. Outline. Who we are

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480 views • 27 slides
Overview of the Current Global Regulatory and Clinical landscape

Overview of the Current Global Regulatory and Clinical landscape

John Kilmartin IMDA Regulatory Steering Committee Chair Senior Regulatory Affairs Director Medtronic Ireland. Overview of the Current Global Regulatory and Clinical landscape. Today (An Industry Perspective). MedTech sector at a glance Clinical trial infrastructure

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473 views • 23 slides
A New Paradigm for Medical Products Regulation in Taiwan

A New Paradigm for Medical Products Regulation in Taiwan

A New Paradigm for Medical Products Regulation in Taiwan. Taiwan Food and Drug Administration 2010.09.10. 1. TFDA Organization Chart. 2. 2. 2. Pharmaceuticals Regulation in Taiwan. Post-Market Management. Pre-Market Approval. Research & Discovery. Preclinical Testing. IND/IDE. NDA/

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517 views • 22 slides
Current Challenges in the Designation and Development of Orphan Products

Current Challenges in the Designation and Development of Orphan Products

Current Challenges in the Designation and Development of Orphan Products. DIA Annual Meeting Marlene Haffner, MD, MPH June 27 th , 2012 Philadelphia, Pennsylvania. Rarity Paradigm. Limited public awareness (invisible)

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300 views • 19 slides
Immunotherapy with Leukocyte Interleukin, Injection for Human Papilloma Virus (HPV) Induced Cervical Dysplasia In HIV Pa

Immunotherapy with Leukocyte Interleukin, Injection for Human Papilloma Virus (HPV) Induced Cervical Dysplasia In HIV Pa

Immunotherapy with Leukocyte Interleukin, Injection for Human Papilloma Virus (HPV) Induced Cervical Dysplasia In HIV Patients. Taylor G 1,2 , Ely L 1 , Wolff T 2 , Davis C 1,2 , Ioffe O 1 , Talor E 3 , Khanna N 2 , Redfield R 1,2 , and Tramont E 4 .

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679 views • 14 slides

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