{"id":314,"date":"2025-09-25T19:58:56","date_gmt":"2025-09-25T12:58:56","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/"},"modified":"2025-09-25T19:58:56","modified_gmt":"2025-09-25T12:58:56","slug":"pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/","title":{"rendered":"Pertanyaan tentang bukti dunia nyata dan keamanan rantai pasokan"},"content":{"rendered":"<div>\n<p class=\"pb-2\">Siklus hidup produk obat tidak berakhir setelah obat diletakkan di pasaran. Ini melampaui, di mana bukti dunia nyata dari penggunaan produk pada pasien memberikan data yang sering diandalkan dalam pengujian keamanan obat yang berkelanjutan atau dalam pengembangan produk obat baru.<\/p>\n<p class=\"pb-2\">\u201cBukti dunia nyata adalah bagian dari kegiatan pharmacovigilance, dan ini jelas wajib untuk semua obat yang dipasarkan,\u201d jelas Siegfried Schmitt, Wakil Presiden, Teknis, di Parexel. &#8220;Kumpulan bukti dunia nyata tidak benar-benar diperlukan di masa lalu, tetapi sekarang. Dan, menurut saya, sangat mungkin untuk tetap, mengingat manfaat yang diberikan bukti dunia nyata. Maka, oleh karena itu, bukti dunia nyata untuk produk tersebut harus dikumpulkan selama Anda menyimpan produk di pasar.&#8221;<\/p>\n<p class=\"pb-2\">Susan J. Schniepp, sesama terkemuka di Regulatory Compliance Associates, melanjutkan untuk menjelaskan bahwa data tentang suatu produk harus dikumpulkan untuk masa pakai produk, karena potensi efek samping yang tidak diketahui yang pernah digunakan oleh pasien. &#8220;Anda mendapatkan indikasi atau efek samping, (ketika) Anda berada dalam uji klinis. Tetapi begitu Anda membukanya hingga populasi yang lebih besar, dan semua orang dapat minum obat, Anda mendapatkan lebih banyak efek samping, karena itu akan mempengaruhi semua orang secara berbeda.&#8221;<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Masalah rantai pasokan seperti apa yang dapat terjadi selama pengangkutan produk farmasi?<\/strong><\/h2>\n<p class=\"pb-2\">&#8220;Kami tidak berbicara tentang gangguan,&#8221; kata Schmitt. &#8220;Kami berbicara tentang fakta -fakta seperti yang kami dengar dari berita, di mana, katakanlah, di Amerika Serikat, seluruh truk (produk) menghilang ke udara tipis. Mereka mencuri truk yang lengkap. Mereka tidak hanya masuk ke dalam truk dan mencuri sesuatu. Ada beberapa pelabuhan di Eropa di mana Anda tidak boleh, untuk mengangkut farmasi Anda; truk apakah itu diterangi?<\/p>\n<p class=\"pb-2\">Klik video di atas untuk menonton Sue dan Siegfried menjawab pertanyaan -pertanyaan berikut:<\/p>\n<ol class=\"my-2\">\n<li class=\"list-decimal ml-8\">Perusahaan saya baru saja meluncurkan novel, obat molekul kecil ke pasar. Untuk berapa lama kita perlu mengumpulkan bukti dunia nyata untuk memantau keamanan dan kemanjurannya?<\/li>\n<li class=\"list-decimal ml-8\">Perusahaan saya sedang menyelidiki opsi untuk terapi sel baru untuk pasar onkologi. Bagaimana kita dapat memanfaatkan bukti dunia nyata dari penelitian kita sendiri dan dari obat-obatan pasca-pasar yang sudah ada di pasaran untuk memilih arah mana yang harus masuk?<\/li>\n<li class=\"list-decimal ml-8\">Kami adalah produsen produk obat, dan kami menganggap keamanan rantai pasokan dengan sangat serius. Sebagai bagian dari penilaian internal kami, kami telah mengidentifikasi transportasi sebagai elemen kritis dari rantai pasokan. Kami menggunakan beberapa pihak ketiga untuk pengangkutan barang kami. Aspek keamanan apa yang harus kita atasi?<\/li>\n<\/ol>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Tentang para ahli<\/strong><\/h2>\n<div class=\"\">\n<div style=\"width:20%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Susan J. Schniepp, Rekan Distinguished, Regulatory Compliance Associates.<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/f1509409f903da03d673b84138face13c4b76d39-1280x1783.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">Susan J. Schniepp adalah Rekan Distinguished di Regulatory Compliance Associates dan anggota <em>Farmasi Teknologi\u00ae<\/em> Dewan Penasihat Editorial.<\/p>\n<div class=\"\">\n<div style=\"width:20%;float:left;max-width:525px;margin:0 1.5rem 1.5rem 0;clear:both;cursor:\" class=\" figure\">\n<div id=\"image-caption\" class=\"text-gray-500 italic\">\n<div class=\"blockText_blockContent__TbCXh\">\n<p class=\"pb-2\">Siegfried Schmitt, PhD, Wakil Presiden, Teknis, Parexel<\/p>\n<\/div>\n<\/div>\n<div class=\"hidden top-(-100%) block w-(1px) transition-opacity duration-500 ease-in-out opacity-0 overflow-hidden\"><img decoding=\"async\" class=\"m-auto absolute inset-0 max-w-(0%) max-h-(0%) border-(3px) border-solid border-white shadow-(0px_0px_8px_rgba(0,0,0,0.3)) box-border transition ease-in-out duration-500\" src=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/98e7110f627feb6c6b69578bac1c66065dde8ab5-1280x1494.jpg?fit=crop&amp;auto=format\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"pb-2\">Siegfried Schmitt adalah wakil presiden, teknis di Parexel dan anggota <em>Farmasi Teknologi\u00ae<\/em> Dewan Penasihat Editorial.<\/p>\n<h2 class=\"text-2xl pb-4 pt-2\"><strong>Tanya seri video ahli<\/strong><\/h2>\n<p class=\"pb-2\">Selamat datang di serial video Ask the Expert. Seri ini merupakan perpanjangan dari kolom cetak yang sudah berjalan lama di Grup PharmTech di mana pakar industri menjawab kualitas umum dan pertanyaan peraturan dari industri. Seri video baru ini akan memperluas bidang topik untuk memasukkan masalah pengembangan dan manufaktur untuk membantu mereka yang bekerja di industri lebih memahami persyaratan bio\/farmasi. Punya pertanyaan yang ingin Anda jawab? Kirim ke ptprojects@mmhgroup.com, dan mungkin muncul di episode mendatang atau kolom cetak.<\/p>\n<p class=\"pb-2\">Kami harap Anda menikmati diskusi!<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Siklus hidup produk obat tidak berakhir setelah obat diletakkan di pasaran. Ini melampaui, di mana bukti dunia nyata dari penggunaan produk pada pasien memberikan data yang sering diandalkan dalam pengujian keamanan obat yang berkelanjutan atau dalam pengembangan produk obat baru. \u201cBukti dunia nyata adalah bagian dari kegiatan pharmacovigilance, dan ini jelas wajib untuk semua obat [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":315,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-314","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pertanyaan tentang bukti dunia nyata dan keamanan rantai pasokan - Nova Anggreni, S.Farm, APT<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pertanyaan tentang bukti dunia nyata dan keamanan rantai pasokan - Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"og:description\" content=\"Siklus hidup produk obat tidak berakhir setelah obat diletakkan di pasaran. Ini melampaui, di mana bukti dunia nyata dari penggunaan produk pada pasien memberikan data yang sering diandalkan dalam pengujian keamanan obat yang berkelanjutan atau dalam pengembangan produk obat baru. \u201cBukti dunia nyata adalah bagian dari kegiatan pharmacovigilance, dan ini jelas wajib untuk semua obat [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\" \/>\n<meta property=\"og:site_name\" content=\"Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-25T12:58:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cdn.sanity.io\/images\/0vv8moc6\/pharmtech\/f1509409f903da03d673b84138face13c4b76d39-1280x1783.jpg?fit=crop&amp;auto=format\" \/>\n<meta name=\"author\" content=\"pythonsonline\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Ditulis oleh\" \/>\n\t<meta name=\"twitter:data1\" content=\"pythonsonline\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimasi waktu membaca\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 menit\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\"},\"author\":{\"name\":\"pythonsonline\",\"@id\":\"https:\/\/pythonsonline.com\/#\/schema\/person\/c1dd578cabc4e398492d9e25f7aff156\"},\"headline\":\"Pertanyaan tentang bukti dunia nyata dan keamanan rantai pasokan\",\"datePublished\":\"2025-09-25T12:58:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\"},\"wordCount\":532,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/pythonsonline.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/pythonsonline.com\/wp-content\/uploads\/2025\/09\/be42a221ef38a7c99d928e4cf61293c8d0524deb-1280x720.jpg\",\"articleSection\":[\"Blog\"],\"inLanguage\":\"id\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\",\"url\":\"https:\/\/pythonsonline.com\/index.php\/2025\/09\/25\/pertanyaan-tentang-bukti-dunia-nyata-dan-keamanan-rantai-pasokan\/\",\"name\":\"Pertanyaan tentang bukti dunia nyata dan keamanan rantai pasokan - 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