Regulatory Perspectives of Gene Regulatory Perspectives of Gene

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V. 한국의 유전자치료제 규제 현황

(식품의약품안전청, 2006년 9월 7일)

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Regulatory Perspectives of Gene Regulatory Perspectives of Gene

Therapy Products in Korea Therapy Products in Korea

2006. 9. 7 Won Shin

Gene Therapy Products Team Korea Food and Drug Administration

동 자료는 2006년 9월 7일 Gene Therapy와 관련하여 Bio Korea 2006 - Conference & Exhibition에서 유전자치료제팀이 발표한 자료입니다. 유전자치료제를 연구하는 산학연 관련자들에게 안전성․유효성 및 품질 평가에 필요한 자료를 제공하기 위해 준비되었습니다.

Presentation of Outline

Introduction

Regulation of Gene Therapy Products Organization of KFDA

IND Approval Process

Evaluation of Gene Therapy Products Take Home Message

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Introduction

Gene Therapy :

The administration of genetic material to specific target cells of a patient for the purpose of preventing or altering a particular disease state

Types of Gene Therapy

Ex vivo : Genetic manipulation is performed ex vivo on cells

In vivo : Cells are modified in vivo by gene therapy given directly to the patient

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