{"id":975,"date":"2020-09-01T11:05:00","date_gmt":"2020-09-01T11:05:00","guid":{"rendered":"https:\/\/www.biochem.de\/?p=975"},"modified":"2022-10-19T10:29:55","modified_gmt":"2022-10-19T10:29:55","slug":"independent-certificates-by-newly-appointed-drug-law-cross-check-expert","status":"publish","type":"post","link":"https:\/\/www.biochem.de\/en\/news\/independent-certificates-by-newly-appointed-drug-law-cross-check-expert\/","title":{"rendered":"Independent certificates by newly appointed drug law cross-check expert"},"content":{"rendered":"\n<p>On September 1st, 2020, Mrs. Clarissa Kohn was appointed as an&nbsp;<strong>expert for the examination of drug counter-samples<\/strong>&nbsp;according to section 65, paragraph 4 of the AMG (German Medicines Act) by the drug monitoring control center of T\u00fcbingen regional council. BioChem Labor f\u00fcr biologische und chemische Analytik GmbH has been working with drug law cross-check experts for many years.&nbsp;<\/p>\n\n\n\n<p>They are entitled to accept officially sealed cross-samples, in particular taken by the supervisory authorities in pharmaceutical companies (manufacturer, distributor or importer), from contract manufacturers, wholesalers or pharmacies, and to check them analytically. In addition, they prepare&nbsp;<strong>independent test certificates on behalf of pharmacies in accordance with Section 6 and 11 of the Pharmacy Operating Regulations.<\/strong><\/p>\n\n\n\n<p>After studying pharmacy at Heidelberg University, which she completed with a license in pharmacy, Mrs. Kohn held management positions in quality assurance and control in the pharmaceutical industry for several years. Initially, she was head of quality assurance and quality control. In 2015 Mrs. Kohn became a Qualified Person (qualification and expertise according to section 14 \/ section 15 AMG) and worked as an information officer in the pharmaceutical industry. She has already worked trustfully with national and international authorities in the context of audits and inspections. Since the beginning of the year, she has been working as&nbsp;<strong>deputy head of quality assurance at BioChem<\/strong>.<\/p>\n\n\n\n<p>\u201cWe got to know Mrs. Kohn as a very responsible, trustworthy and highly competent expert in the field of quality assurance and control\u201d says Dr J\u00fcrgen Branke, Technical Managing Director of BioChem. \u201cWe are very pleased that the responsible regional council has confirmed Mrs. Kohn\u2019s competence by appointing her as drug law cross-check expert.\u201d<\/p>\n\n\n\n<p>Mrs. Kohn has been included in the list of appointed drug law cross-check experts on the website of the Federal Ministry of Health (for more details see the\u00a0<a href=\"https:\/\/www.bundesgesundheitsministerium.de\/fileadmin\/Dateien\/3_Downloads\/A\/Arzneimittelversorgung\/Verzeichnis_Vollzug_des_Arzneimittelverzeichnis\/Anlage_III.pdf\">list of drug law experts appointed by the competent state authorities for the examination of pharmaceutical samples in accordance with Section 65 (4) AMG (Annex III)<\/a>).<\/p>\n\n\n\n<p><span class=\"has-inline-color has-white-color\">.<\/span><\/p>\n\n\n\n<div class=\"block__contact-box mb-6 mb-md-7\" id=\"block_633d8bd670dd8\">\n    <div class=\"container\">\n        <div class=\"row\">\n            <div class=\"block__contact-box__inner col-12 col-md-10 offset-md-1 d-flex flex-column p-3 p-sm-6 shadow\">\n                                    <h2 class=\"order-2 heading-sm\">Contact the experts of our quality assurance department<\/h2>\n                                <div class=\"badge-orange order-1 mb-4\">Contact<\/div>\n                                    <div class=\"order-3 block__contact-box__description\"><p>The experts in our quality assurance department will be pleased to advise you and support you with your quality-related questions.<\/p>\n<p>Please use our contact form for your enquiry.<\/p>\n<\/div>\n                                <div class=\"block__contact-box__buttons order-4 mt-5 mt-xl-5\">\n                                                                        <a class=\"button md-button-fw order-4 text-center\" href=\"https:\/\/www.biochem.de\/en\/contact\/#quality-assurance-qp\">Contact person quality assurance | qualified person<\/a>\n                                                                                                                    <a class=\"button md-button-fw order-4 text-center\" href=\"https:\/\/www.biochem.de\/en\/contact\/\">Contact form<\/a>\n                                                            <\/div>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On September 1st, 2020, Mrs. Clarissa Kohn was appointed as an&nbsp;expert for the examination of drug counter-samples&nbsp;according to section 65, [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":2653,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-975","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/975","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/comments?post=975"}],"version-history":[{"count":15,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/975\/revisions"}],"predecessor-version":[{"id":3020,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/posts\/975\/revisions\/3020"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media\/2653"}],"wp:attachment":[{"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/media?parent=975"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/categories?post=975"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.biochem.de\/en\/wp-json\/wp\/v2\/tags?post=975"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}