'15년도 제5차 美FDA 의료기기 UDI 규정 대응방안 세미나

<h4>'15년도 제5차 美FDA 의료기기 UDI 규정 대응방안 세미나</h4> 2015.09.23<div class="info"><ul class="file"><li> 첨부파일 </li><li><a title="클릭시 다운로드됩니다." href="xxjavascript:down('(유첨) UDI 세미나 참가신청서.doc');">(유첨) UDI 세미나 참가신청서.doc</a> </li><li><a href='javascript:fileFilterViewer("http://cfile286.uf.daum.net/attach/2325A93B55F306911ACFD7", "/cfile286/23/25A93B55F306911ACFD7", "(유첨) UDI 세미나 참가신청서.doc", "grpid%3D1PFM7%26fldid%3D5By6%26dataid%3D9728%26fileid%3D1%26regdt%3D20150912015145&url=http%3A%2F%2Fcfile286.uf.daum.net%2Fattach%2F2325A93B55F306911ACFD7")'><img src="https://t1.daumcdn.net/daumtop_deco/icon/icon.hanmail.net/editor/p_etc_s.gif" border="0" alt="첨부파일" class="vam"/> (유첨) UDI 세미나 참가신청서.doc</a></li><li> </li></ul> 담당부서 국제표준팀 <ul class="file"></ul> </div><section class="board-view"><table><tbody><tr style="display: none;"><td colspan="4"><textarea name="txt_source" id="txt_source"></textarea> </td></tr><tr><td class="view_td_cont" colspan="4"><div id="div_view_result" style="padding-left: 15px;">  해외 의료기기산업 규제동향 관련입니다.   상공회의소는 지금까지 4차에 걸쳐 美FDA 등 주요국 의료기기 UDI(Unique Device Identification) 규정과 그 대응방안에 대해 논의 해 왔습니다.     이번 5차 세미나 에서는, 1        외부 전문가를 초빙하여 FDA GUDID (Global UDI Database) 규정 과, 2         GS1 표준(BarCodes, ID코드, Applications)을 이용한 UDI 적용방안 을 보다 상세히   다룰 예정입니다.     유럽, 중국 등 주요국 UDI 정책동향에 대해 살펴보고 특히 美FDA의 UDI 규정에 대한 대응방안을 심도있게 논의할 이번 5차 세미나에 의료기기 수출기업 관계자분 들의 관심과 참여 바랍니다.       --------------------------------------------------------------------------------------------------- o 행사명 : 2015년도   제5차 美FDA 의료기기 UDI 규정 대응방안 세미나     o 일시 : 9. 23(수) 14:00-18:00   o 장소 : 대한상공회의소 중회의실A (지하2층)           * 서울시 중구 세종대로39 대한상공회의소   o 참석대상 : 의료기기업계 Regulatory Affairs, 물류 및 품질부서 등 관계자 (선착순 100명)   o 프로그램(안)   <table style="border-color: black; width: 614px; border-collapse: collapse;" border="0" cellspacing="0" cellpadding="0"><tbody><tr><td width="109" height="29" class="xl66" style="background: yellow; border-width: 1px 1px medium; border-style: solid solid none; border-color: gray gray black; width: 109px; height: 29px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">시간 </td><td width="235" class="xl67" style="background: yellow; border-width: 1px 1px medium medium; border-style: solid solid none none; border-color: gray gray black black; width: 282px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">발표주제 </td><td width="100" class="xl67" style="background: yellow; border-width: 1px 1px medium medium; border-style: solid solid none none; border-color: gray gray black black; width: 112px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">발표자 </td><td width="127" class="xl68" style="background: yellow; border-width: 1px 1px medium medium; border-style: solid solid none none; border-color: gray gray black black; width: 117px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">비고 </td></tr><tr><td height="46" class="xl64" style="border: 1px solid gray; border-image: none; height: 46px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">14:00-15:00 </td><td width="235" class="xl80" style="border-width: 1px 1px 1px medium; border-style: solid solid solid none; border-color: gray gray gray black; width: 282px; text-align: left; color: black; padding-top: 1px; padding-right: 1px; padding-left: 15px; font-family:; font-style: normal; font-weight: 700; text-decoration: none; vertical-align: middle; white-space: nowrap;">UDI 개요 및 글로벌 동향 </td><td width="100" class="xl65" style="border-width: 1px 1px medium; border-style: solid solid none; border-color: gray gray black; width: 112px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;" rowspan="2">국제표준팀 </td><td class="xl81" style="border-width: 1px 1px medium; border-style: solid solid none; border-color: gray gray black; width: 109px; text-align: center; color: red; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 700; text-decoration: none; vertical-align: middle; white-space: nowrap;" rowspan="2">기본 과정 (초심자用) </td></tr><tr><td height="68" class="xl69" style="border-width: medium 1px; border-style: none solid; border-color: black gray; height: 68px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">15:00-16:00 </td><td width="235" class="xl70" style="border-width: medium 1px medium medium; border-style: none solid none none; border-color: black gray black black; width: 282px; text-align: left; color: black; padding-top: 1px; padding-right: 1px; padding-left: 15px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: normal;"><span class="font7" style="border-color: black; color: black; line-height: 150%; font-family: 맑은 고딕; font-size: 15px; font-style: normal; font-weight: 700; text-decoration: none; margin-top: 0px; margin-bottom: 0px;">UDI 국제표준 - GS1 <span class="font6" style="border-color: black; color: black; line-height: 150%; font-family: 맑은 고딕; font-size: 15px; font-style: normal; font-weight: 400; text-decoration: none; margin-top: 0px; margin-bottom: 0px;">  a. GS1 개요  b. GS1 식별코드/바코드/응용식별자 </td></tr><tr><td height="64" class="xl72" style="background: rgb(198, 224, 180); border: 1px solid gray; border-image: none; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">16:00-17:00 </td><td width="235" height="64" class="xl73" style="background: rgb(198, 224, 180); border-width: 1px 1px 1px medium; border-style: solid solid solid none; border-color: gray gray gray black; width: 282px; text-align: left; color: black; padding-top: 1px; padding-right: 1px; padding-left: 15px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: normal;">US FDA UDI 대응방안   <span class="font7" style="border-color: black; color: black; line-height: 150%; font-family: 맑은 고딕; font-size: 15px; font-style: normal; font-weight: 700; text-decoration: none; margin-top: 0px; margin-bottom: 0px;">Part 1.   UDI Labeling </td><td width="100" height="64" class="xl74" style="background: rgb(198, 224, 180); border-width: 1px 1px 1px medium; border-style: solid solid solid none; border-color: gray gray gray black; width: 112px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">국제표준팀 </td><td height="130" class="xl75" style="background: rgb(198, 224, 180); border: 1px solid gray; border-image: none; width: 109px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;" rowspan="2">  </td></tr><tr><td height="66" class="xl76" style="background: rgb(198, 224, 180); border-width: medium 1px 1px; border-style: none solid solid; border-color: black gray gray; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: nowrap;">17:00-18:00 </td><td width="235" height="66" class="xl77" style="background: rgb(198, 224, 180); border-width: medium 1px 1px medium; border-style: none solid solid none; border-color: black gray gray black; width: 282px; text-align: left; color: black; padding-top: 1px; padding-right: 1px; padding-left: 15px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: normal;">US FDA UDI 대응방안   <span class="font7" style="border-color: black; color: black; line-height: 150%; font-family: 맑은 고딕; font-size: 15px; font-style: normal; font-weight: 700; text-decoration: none; margin-top: 0px; margin-bottom: 0px;">Part 2.   GUDID </td><td width="100" height="66" class="xl78" style="background: rgb(198, 224, 180); border-width: medium 1px 1px medium; border-style: none solid solid none; border-color: black gray gray black; width: 112px; text-align: center; color: black; padding-top: 1px; padding-right: 1px; padding-left: 1px; font-family:; font-style: normal; font-weight: 400; text-decoration: none; vertical-align: middle; white-space: normal;">(외부전문가) </td></tr></tbody></table>* 상기 프로그램은 발표자 사정에 따라 변경될 수 있습니다.   o 참가신청 : (유첨) 신청서 작성 후, 이메일 송부 (email to <a href="mailto:srlee@korcham.net">srlee@korcham.net </a>)   o 문의 : 국제표준팀 (02-6050-1504, <a href="mailto:srlee@korcham.net" target="_blank">srlee@korcham.net </a>)     (유  첨)    참가신청서 1부. </div></td></tr></tbody></table></section>