{"id":70563,"date":"2024-07-23T15:17:20","date_gmt":"2024-07-23T15:17:20","guid":{"rendered":"https:\/\/staging.registrarcorp.com\/?post_type=press-release&#038;p=40290"},"modified":"2026-08-03T12:55:19","modified_gmt":"2026-08-03T12:55:19","slug":"adverse-event-management-launch","status":"publish","type":"media-coverages","link":"https:\/\/staging.registrarcorp.com\/vi\/media-coverages\/press-release\/adverse-event-management-launch\/","title":{"rendered":"Ng\u00e0nh m\u1ef9 ph\u1ea9m ch\u01b0a chu\u1ea9n b\u1ecb cho c\u00e1c y\u00eau c\u1ea7u b\u00e1o c\u00e1o bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i m\u1edbi c\u1ee7a FDA"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><em>C\u01a1 quan \u0110\u0103ng k\u00fd Corp ra m\u1eaft Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i \u0111\u1ec3 FDA MoCRA tu\u00e2n th\u1ee7<\/em><\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Hampton, Va., Ng\u00e0y 23 th\u00e1ng 7 n\u0103m 2024 \u2014<\/strong>\u00a0<a href=\"https:\/\/www.registrarcorp.com\/\">Registrar Corp<\/a>, c\u00f4ng ty tu\u00e2n th\u1ee7 FDA l\u1edbn nh\u1ea5t th\u1ebf gi\u1edbi v\u1edbi 32.000 kh\u00e1ch h\u00e0ng t\u1ea1i 190 qu\u1ed1c gia, h\u00f4m nay \u0111\u00e3 c\u00f4ng b\u1ed1 ra m\u1eaft\u00a0<a href=\"https:\/\/staging.registrarcorp.com\/services\/adverse-event-reporting\/adverse-events-management\/\">Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i (AEM).<\/a> Ph\u1ea7n m\u1ec1m \u0111\u1ed9c nh\u1ea5t v\u00f4 nh\u1ecb cho ph\u00e9p c\u00e1c c\u00f4ng ty m\u1ef9 ph\u1ea9m tu\u00e2n th\u1ee7 \u0110\u1ea1o lu\u1eadt Hi\u1ec7n \u0111\u1ea1i h\u00f3a M\u1ef9 ph\u1ea9m (MoCRA) c\u1ee7a C\u1ee5c Qu\u1ea3n l\u00fd Th\u1ef1c ph\u1ea9m v\u00e0 D\u01b0\u1ee3c ph\u1ea9m Hoa K\u1ef3 (FDA).\u00a0 <\/p>\n\n<p class=\"wp-block-paragraph\"><strong>C\u00e1c c\u00f4ng ty m\u1ef9 ph\u1ea9m kh\u00f4ng \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb cho c\u00e1c y\u00eau c\u1ea7u v\u1ec1 bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i m\u1edbi c\u1ee7a FDA<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">MoCRA c\u00f3 c\u00e1c y\u00eau c\u1ea7u m\u1edbi, nghi\u00eam ng\u1eb7t \u0111\u1ed1i v\u1edbi vi\u1ec7c b\u00e1o c\u00e1o Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i d\u1ef1a tr\u00ean quy tr\u00ecnh b\u00e1o c\u00e1o bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i c\u1ee7a thu\u1ed1c v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf c\u1ee7a FDA, bao g\u1ed3m:\u00a0<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Hi\u1ec3n th\u1ecb th\u00f4ng tin li\u00ean h\u1ec7 tr\u00ean c\u1ea3 bao b\u00ec ch\u00ednh v\u00e0 ph\u1ee5<\/li>\n\n\n\n<li>Thu th\u1eadp th\u00f4ng tin c\u00e1 nh\u00e2n v\u00e0 y t\u1ebf chi ti\u1ebft t\u1eeb ng\u01b0\u1eddi ti\u00eau d\u00f9ng<\/li>\n\n\n\n<li>\u0110i\u1ec1u tra \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh xem bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i c\u00f3 ph\u1ea3i l\u00e0 bi\u1ebfn c\u1ed1 \u201cnghi\u00eam tr\u1ecdng\u201d hay kh\u00f4ng<\/li>\n\n\n\n<li>B\u00e1o c\u00e1o bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i \u201cnghi\u00eam tr\u1ecdng\u201d cho FDA trong v\u00f2ng 15 ng\u00e0y l\u00e0m vi\u1ec7c<\/li>\n\n\n\n<li>Ghi l\u1ea1i t\u1ea5t c\u1ea3 c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i li\u00ean quan \u0111\u1ebfn s\u1ee9c kh\u1ecfe v\u00e0 duy tr\u00ec trong t\u1ed1i \u0111a 6 n\u0103m<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">C\u00e1c quy \u0111\u1ecbnh m\u1edbi s\u1ebd kh\u00f4ng ch\u1ec9 \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn c\u00e1c b\u1ed9 ph\u1eadn tu\u00e2n th\u1ee7 v\u00e0 qu\u1ea3n l\u00fd m\u00e0 c\u00f2n \u0111\u00f2i h\u1ecfi s\u1ef1 ph\u1ed1i h\u1ee3p ch\u1eb7t ch\u1ebd v\u1edbi c\u00e1c b\u1ed9 ph\u1eadn ti\u1ebfp th\u1ecb (ghi nh\u00e3n s\u1ea3n ph\u1ea9m), ch\u1ea5t l\u01b0\u1ee3ng v\u00e0 s\u1ea3n xu\u1ea5t (\u0111i\u1ec1u tra), ph\u00e1p l\u00fd (tr\u00e1ch nhi\u1ec7m c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng) v\u00e0 R &amp; D (an to\u00e0n c\u00f4ng th\u1ee9c).\u00a0\u00a0<\/p>\n\n<p class=\"wp-block-paragraph\">\u201cY\u00eau c\u1ea7u B\u00e1o c\u00e1o B\u1ea5t l\u1ee3i c\u1ee7a MoCRA l\u00e0 v\u00f4 c\u00f9ng ph\u1ee9c t\u1ea1p v\u00e0 quy tr\u00ecnh khi\u1ebfu n\u1ea1i c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng hi\u1ec7n t\u1ea1i \u0111\u01a1n gi\u1ea3n l\u00e0 s\u1ebd kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng\u201d, Jaclyn Bellomo, Gi\u00e1m \u0111\u1ed1c c\u1ea5p cao v\u1ec1 Khoa h\u1ecdc M\u1ef9 ph\u1ea9m v\u00e0 \u0110i\u1ec1u ti\u1ebft c\u1ee7a Nh\u00e0 \u0111\u0103ng k\u00fd cho bi\u1ebft. D\u1eef li\u1ec7u y t\u1ebf c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng c\u1ea7n \u0111\u01b0\u1ee3c thu th\u1eadp an to\u00e0n, x\u1eed l\u00fd trong th\u1eddi gian th\u1ef1c v\u00e0 \u0111i\u1ec1u tra nhanh ch\u00f3ng \u0111\u1ec3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u b\u00e1o c\u00e1o b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng trong 15 ng\u00e0y.\u00a0<\/p>\n\n<p class=\"wp-block-paragraph\">Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i (AEM) c\u1ee7a Nh\u00e0 \u0111\u0103ng k\u00fd \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e2y d\u1ef1ng nh\u1eb1m m\u1ee5c \u0111\u00edch cho c\u00e1c c\u00f4ng ty m\u1ef9 ph\u1ea9m. N\u1ec1n t\u1ea3ng AEM ti\u1ebfp nh\u1eadn d\u1eef li\u1ec7u y t\u1ebf nh\u1ea1y c\u1ea3m c\u1ee7a ng\u01b0\u1eddi ti\u00eau d\u00f9ng m\u1ed9t c\u00e1ch an to\u00e0n, theo d\u00f5i t\u1ea5t c\u1ea3 c\u00e1c s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i cho t\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m tr\u00ean to\u00e0n c\u1ea7u, truy\u1ec1n th\u00f4ng tin \u0111\u1ebfn c\u00e1c b\u00ean li\u00ean quan n\u1ed9i b\u1ed9 v\u00e0 \u0111\u1ecbnh d\u1ea1ng c\u00e1c s\u1ef1 ki\u1ec7n b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng sang \u0111\u1ecbnh d\u1ea1ng FDA MedWatch \u0111\u1ec3 g\u1eedi cho FDA.\u00a0<\/p>\n\n<p class=\"wp-block-paragraph\"><strong>L\u1ee3i \u00edch ch\u00ednh c\u1ee7a Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i c\u1ee7a Nh\u00e0 \u0111\u0103ng k\u00fd:<\/strong><\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Ng\u01b0\u1eddi ti\u00eau d\u00f9ng th\u00e2n thi\u1ec7n:\u00a0<\/strong>\u00a0Ng\u01b0\u1eddi ti\u00eau d\u00f9ng c\u00f3 th\u1ec3 nhanh ch\u00f3ng qu\u00e9t m\u00e3 QR tr\u00ean nh\u00e3n v\u00e0 nh\u1eadp d\u1eef li\u1ec7u, h\u00ecnh \u1ea3nh v\u00e0 t\u00e0i li\u1ec7u c\u1ea7n thi\u1ebft \u0111\u1ec3 nhanh ch\u00f3ng \u0111i\u1ec1u tra\u00a0\u00a0<\/li>\n\n\n\n<li>Theo <strong>d\u00f5i v\u00e0 gi\u00e1m s\u00e1t theo th\u1eddi gian th\u1ef1c:<\/strong>\u00a0Theo d\u00f5i c\u00e1c bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i tr\u00ean to\u00e0n c\u1ea7u cho m\u1ecdi SKU theo th\u1eddi gian th\u1ef1c v\u00e0 nh\u1eadn \u0111\u01b0\u1ee3c ch\u1ec9 b\u00e1o s\u1edbm nh\u1ea5t v\u1ec1 c\u00e1c v\u1ea5n \u0111\u1ec1 ti\u1ec1m \u1ea9n v\u1ec1 an to\u00e0n ho\u1eb7c ch\u1ea5t l\u01b0\u1ee3ng<\/li>\n\n\n\n<li><strong>B\u1ea3o v\u1ec7 D\u1eef li\u1ec7u Y t\u1ebf\/C\u00e1 nh\u00e2n:<\/strong>\u00a0B\u1ea3o m\u1eadt ISO27001-certified \u0111\u1ec3 l\u01b0u tr\u1eef v\u00e0 truy\u1ec1n th\u00f4ng tin nh\u1eadn d\u1ea1ng c\u00e1 nh\u00e2n v\u00e0 y t\u1ebf (PII)<\/li>\n\n\n\n<li><strong>FDA MedWatch-s\u1eb5n s\u00e0ng:<\/strong>\u00a0B\u00e1o c\u00e1o bi\u1ebfn c\u1ed1 b\u1ea5t l\u1ee3i nghi\u00eam tr\u1ecdng \u0111\u01b0\u1ee3c \u0111\u1ecbnh d\u1ea1ng tr\u01b0\u1edbc theo y\u00eau c\u1ea7u c\u1ee7a FDA \u0111\u1ec3 t\u1ea3i l\u00ean v\u00e0 n\u1ed9p nhanh<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">&#8220;Trong s\u00e1u th\u00e1ng qua, ch\u00fang t\u00f4i \u0111\u00e3 gi\u00fap h\u01a1n m\u1ed9t ng\u00e0n c\u00f4ng ty m\u1ef9 ph\u1ea9m c\u00f3 \u0111\u01b0\u1ee3c MoCRA s\u1eb5n s\u00e0ng v\u1edbi danh s\u00e1ch s\u1ea3n ph\u1ea9m, \u0111\u0103ng k\u00fd v\u00e0 \u0111\u00e1nh gi\u00e1 nh\u00e3n hi\u1ec7u,&#8221; Raj Shah, Gi\u00e1m \u0111\u1ed1c \u0111i\u1ec1u h\u00e0nh c\u1ee7a Registrar Corp cho bi\u1ebft. \u201cKhi c\u01a1 quan FDA t\u0103ng c\u01b0\u1eddng th\u1ef1c thi v\u00e0 c\u00e1c nh\u00e0 b\u00e1n l\u1ebb nh\u1ea5n v\u00e0o c\u00e1c th\u01b0\u01a1ng hi\u1ec7u \u0111\u1ec3 tu\u00e2n th\u1ee7 \u0111\u1ea7y \u0111\u1ee7 MoCRA, ch\u00fang t\u00f4i nh\u1eadn ra nhu c\u1ea7u c\u1ea5p thi\u1ebft \u0111\u1ec3 gi\u1ea3i quy\u1ebft nhu c\u1ea7u v\u1ec1 Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i c\u1ee7a h\u1ecd b\u1eb1ng ph\u1ea7n m\u1ec1m AEM c\u1ee7a ch\u00fang t\u00f4i.\u201d<\/p>\n\n<p class=\"wp-block-paragraph\">\u0110\u1ec3 t\u00ecm hi\u1ec3u th\u00eam v\u1ec1 Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i c\u1ee7a Registrar Corp,\u00a0<a href=\"https:\/\/staging.registrarcorp.com\/services\/adverse-event-reporting\/adverse-events-management\/\">h\u00e3y truy c\u1eadp trang web c\u1ee7a ch\u00fang t\u00f4i<\/a>.<\/p>\n\n<p class=\"wp-block-paragraph\"><strong>###<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Th\u01b0\u01a1ng hi\u1ec7u: Registrar Corp<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.registrarcorp.com\/\">Registrar Corp<\/a>\u00a0l\u00e0 c\u00f4ng ty tu\u00e2n th\u1ee7 FDA l\u1edbn nh\u1ea5t th\u1ebf gi\u1edbi v\u1edbi h\u01a1n 32.\u00a0 000 kh\u00e1ch h\u00e0ng t\u1ea1i 190 qu\u1ed1c gia. Ph\u1ea7n m\u1ec1m, d\u1ecbch v\u1ee5 v\u00e0 \u0111\u00e0o t\u1ea1o c\u1ee7a ch\u00fang t\u00f4i gi\u00fap c\u00e1c kh\u00e1ch h\u00e0ng m\u1ef9 ph\u1ea9m, th\u1ef1c ph\u1ea9m, d\u01b0\u1ee3c ph\u1ea9m v\u00e0 thi\u1ebft b\u1ecb y t\u1ebf tu\u00e2n th\u1ee7 c\u00e1c quy \u0111\u1ecbnh ph\u1ee9c t\u1ea1p c\u1ee7a FDA v\u00e0 gi\u1eef cho m\u1ecdi ng\u01b0\u1eddi kh\u1ecfe m\u1ea1nh v\u00e0 an to\u00e0n.<\/p>\n\n<p class=\"wp-block-paragraph\"><strong>\u0110\u1ea7u m\u1ed1i li\u00ean h\u1ec7 c\u1ee7a b\u1ed9 ph\u1eadn truy\u1ec1n th\u00f4ng:<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">b\u1edfi Ann Noder<\/p>\n\n<p class=\"wp-block-paragraph\">Pitch PR<\/p>\n\n<p class=\"wp-block-paragraph\">480.263.1557<\/p>\n\n<p class=\"wp-block-paragraph\"><a href=\"mailto:Ann@PitchPublicRelations.com\"><strong>Ann@PitchPublicRelations.com<\/strong><\/a><strong><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>C\u01a1 quan \u0110\u0103ng k\u00fd Corp ra m\u1eaft Ph\u1ea7n m\u1ec1m Qu\u1ea3n l\u00fd Bi\u1ebfn c\u1ed1 B\u1ea5t l\u1ee3i \u0111\u1ec3 FDA MoCRA tu\u00e2n th\u1ee7 Hampton, Va., Ng\u00e0y 23 th\u00e1ng 7 n\u0103m 2024 \u2014\u00a0Registrar Corp, c\u00f4ng ty tu\u00e2n th\u1ee7 FDA l\u1edbn nh\u1ea5t th\u1ebf gi\u1edbi v\u1edbi 32.000 kh\u00e1ch h\u00e0ng t\u1ea1i 190 qu\u1ed1c gia, h\u00f4m nay \u0111\u00e3 c\u00f4ng b\u1ed1 ra m\u1eaft\u00a0Ph\u1ea7n m\u1ec1m<\/p>\n","protected":false},"author":33,"featured_media":70570,"template":"","meta":{"_acf_changed":false,"content-type":""},"categories-mc":[1506],"class_list":["post-70563","media-coverages","type-media-coverages","status-publish","has-post-thumbnail","hentry","categories-mc-press-releases"],"acf":[],"_links":{"self":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media-coverages\/70563","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media-coverages"}],"about":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/types\/media-coverages"}],"author":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/users\/33"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media\/70570"}],"wp:attachment":[{"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/media?parent=70563"}],"wp:term":[{"taxonomy":"categories-mc","embeddable":true,"href":"https:\/\/staging.registrarcorp.com\/vi\/wp-json\/wp\/v2\/categories-mc?post=70563"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}