The ICH is announcing that it will be releasing a Request for Information (RFI) expected in October to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force\u2019s initial assessment for a secure standardised regulatory platform.<\/p>\n
In March of 2024, ICH formed the ICH PQKM Task Force to begin exploring what it would take to establish and govern a secure, standardised technology platform to both enable the PQKM vision and make it scalable to other collaborative regulatory use cases. (Official press releases about the ICH PQKM Task Force and related efforts and pilots can be seen HERE<\/a> and HERE<\/a>). The PQKM vision is to align efforts to support a global regulatory capability for chemistry, manufacturing, and control (CMC) related post approval change (PAC) submissions supporting products and facilities. The ICH PQKM Task Force has been assessing multiple requirements for operating a secure standardised platform including potential governance and operating models; alignment with relevant privacy, legal and regulatory guidelines across jurisdictions; and data security and technology capabilities needed within the platform. Anticipated capabilities and third-party provisioning services needed to establish and govern the technology platform will be incorporated in an RFI.<\/p>\n The RFI will focus on gaining vendor feedback to the ICH PQKM Task Force\u2019s initial findings and approach, understanding vendor capabilities, and eliciting high-level vendor solutions. The RFI is planned to be released in October of calendar year 2024 and additional instructions will be provided at that time for an interactive vendor session. Parties interested in participating in the RFI process are asked to send notification along with contact information to PQKMtaskforce@ich.org<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" The ICH is announcing that it will be releasing a Request for Information (RFI) expected in October to determine interest and potential approaches to support the ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force\u2019s initial assessment for a secure standardised regulatory platform.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[27],"tags":[],"class_list":["post-2050","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2050","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/comments?post=2050"}],"version-history":[{"count":0,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/posts\/2050\/revisions"}],"wp:attachment":[{"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/media?parent=2050"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/categories?post=2050"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dev.ich.org\/index.php\/wp-json\/wp\/v2\/tags?post=2050"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}