{"id":18347,"date":"2018-04-23T14:17:18","date_gmt":"2018-04-23T14:17:18","guid":{"rendered":"http:\/\/www.intermed.al\/?page_id=18347"},"modified":"2024-11-13T14:51:54","modified_gmt":"2024-11-13T14:51:54","slug":"sherbimi-rregullator-dhe-farmakovigjilenca-2","status":"publish","type":"page","link":"https:\/\/www.intermed.al\/en\/sherbimi-rregullator-dhe-farmakovigjilenca-2\/","title":{"rendered":"Regulatory Affairs & Pharmacovigilance"},"content":{"rendered":"
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QUALITY ASSURANCE<\/strong><\/span><\/h2>\n

The quality assurance system and compliance play a fundamental role in building trust with our partners and in ensuring proper patient care.<\/p>\n

The verification of company policies, as part of the quality assurance framework, ensures that the management of medicines marketed and distributed by INTERMED complies with national and European regulatory requirements for Good Storage and Distribution Practices.<\/p>\n

The quality assurance system provides patients with the assurance that the medicines they use meet the required quality standards and are safe for their health.<\/p>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><\/div>

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REGULATORY AFFAIRS AND PHARMACOVIGILANCE<\/strong><\/span><\/h2>\n

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The Regulatory Affairs Office serves as a key point in maintaining the relationship between INTERMED and the National Agency for Medicines and Medical Devices (AKBPM) \/ the Ministry of Health.<\/p>\n

Among the activities carried out by the Regulatory Affairs Office at INTERMED are:<\/span><\/strong><\/p>\n

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  • Verification of registration dossiers in accordance with the approved format (eCTD)<\/li>\n
  • Submission of registration applications for pharmaceutical products marketed by INTERMED<\/li>\n
  • Submission of variations and follow-up of their approval<\/li>\n
  • Patient safety is our top priority.<\/li>\n<\/ul>\n

    Pharmacovigilance refers to post-marketing pharmacovigilance activities and is related to product safety management through the collection, monitoring, and reporting of adverse drug reactions (ADR) and other undesirable events.<\/p>\n\n\t\t<\/div> \n\t<\/div> <\/div><\/div><\/div><\/div><\/div><\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"SIGURIMI I CIL\u00cbSIS\u00cb Sistemi i sigurimit t\u00eb cil\u00ebsis\u00eb dhe p\u00ebrputhshm\u00ebria luajn\u00eb nj\u00eb rol thelb\u00ebsor n\u00eb krijimin e besueshm\u00ebris\u00eb n\u00eb lidhjen me partner\u00ebt tan\u00eb dhe kujdesin e pacientit. Verifikimi i politikave t\u00eb kompanis\u00eb, si hallk\u00eb e sigurimit t\u00eb cil\u00ebsis\u00eb,\u00a0 jep siguri q\u00eb menaxhimi i barnave t\u00eb...","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"full_width.php","meta":{"footnotes":""},"class_list":["post-18347","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/pages\/18347","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/comments?post=18347"}],"version-history":[{"count":26,"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/pages\/18347\/revisions"}],"predecessor-version":[{"id":19592,"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/pages\/18347\/revisions\/19592"}],"wp:attachment":[{"href":"https:\/\/www.intermed.al\/en\/wp-json\/wp\/v2\/media?parent=18347"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}