Page 76 - 2020食藥署年報(中文版)

ୋɚື cן࢝ᔼᐕኜҿ਷ყΥЪ

݁ഄৎ๕๕
݁ഄৎ

͉໇ዝϋԸߧɢપਗᔼᐕኜҿ਷ყΥЪdጐ฽ਞၾ਷ყଡ଼ᔌdԨن՟፬ଣ਷ყึ
ᙄݺਗd੶ʷ਷ყਞၾʿᅂᚤɢdܔ࿴਷ყʷʘᔼᐕኜҿج஝ᐑྤf108ϋપਗࠠᓃ

ܼ̍͡ሗ፬ଣᔼᐕኜҿج஝߅ኪ৅ᇖՙ൳ʕː€Regulatory Science Training Center

of Excellence, CoE΋ಂ޼ীึeਞၾIMDRFج஝ԫਕeໝྼၽ˚ᖹيج஝ΥЪ࣪

ݖ՘ᙄʿ੶ʷၾ؇՘਷࢕ᔼᖹج஝ʹݴf

ੂБഄଫБഄଫ
ੂ

ɓe ᑘ፬"1&$ᔼᐕኜҿᅺ๟ج஝߅ኪ΋ಂ৅ᇖՙ൳ʕː޼ীึ

107ϋֵ˸ᔼᐕኜҿᅺ๟ᙄᕚdΣAPEC LSIF-RHSC€Life Sciences Innovation

Forum, LSIFiRegulatory Harmonization Steering Committee, RHSC͡ሗ፬ଣᔼ
ᐕኜҿج஝߅ኪ৅ᇖՙ൳ʕː€Regulatory Science Training Center of Excellence,

CoE΋ಂ޼ীึdԨ׵108ϋ3˜21˚ᐏ੻RHSC஢̙f108ϋ10˜22˚Ї24˚፬ଣ

˜2019 APECᔼᐕኜҿᅺ๟ج஝߅ኪ΋ಂ৅ᇖՙ൳ʕː޼ীึ™€ྡ5-3dʱԮ਷

ყᅺ๟൙ПᔼᐕኜҿτΌၾࣖঐʘࡡۆʿ຾᜕dԨணࠇਖ਼ᕚစᑺeʱଡ଼ীሞeࣩԷ޼

ӺʿႡிᅀਞஞഃݺਗf

ɚe ن՟̋ɝ*.%3'ʈЪʃଡ଼Ԩܵᚃݼࡰਞၾϋึ

਷ყᔼᐕኜҿ˴၍ዚᗫሞእ€IMDRFމΌଢᔼᐕኜҿج஝ዚᗫଡ଼ϓʘІᗴ׌

਷ყଡ଼ᔌd͉໇׵108ϋ6˜ᐏ੻IMDRF၍ଣ։ࡰึᄲࣨΝจd˸ԭݲᔼᐕኜҿج஝

ሜձึ€Asian Harmonization Working Party, AHWP˾ڌԒʱϓމ᜗̮ൢᓙᔼᐕ
ኜҿʱᗳࡡۆ€Principles of IVD Classificationʃଡ଼ึࡰdਞၾ޴ᗫܸˏ޼ࠈʈ

ЪfϤ̮d͉໇͵׵108ϋ3˜ʿ9˜˾ڌAPEC̈ࢩIMDRF၍ଣ։ࡰึึᙄdԨ׵ʮ

කɽึʕజѓAPECʈЪආ࢝f

74