{"id":33511,"date":"2020-08-13T14:47:53","date_gmt":"2020-08-13T13:47:53","guid":{"rendered":"https:\/\/www.biotechpharmasummit.com\/?page_id=33511"},"modified":"2023-05-02T22:13:17","modified_gmt":"2023-05-02T21:13:17","slug":"barbara-valenta-singer","status":"publish","type":"page","link":"https:\/\/www.biotechpharmasummit.com\/index.php\/biosimilars-biologics-2019-speakers\/barbara-valenta-singer\/","title":{"rendered":"Barbara Valenta-Singer"},"content":{"rendered":"<div class=\"vgblk-rw-wrapper limit-wrapper\">\n\n\t<h2>Barbara Valenta-Singer<\/h2>\n<h4>Chief Medical Officer Fresenius-Kabi SwissBioSim<\/h4>\n\t<p><strong>Previous work experience as<\/strong><\/p>\n<ul>\n<li><strong>Independent Clinical Consultant<\/strong>\u00a0Dr Barbara Valenta-Singer Consulting e.U.<\/li>\n<li><strong>Vice President Clinical Development Operations<\/strong>\u00a0Shire ( Baxalta Acquisition)<\/li>\n<li><strong>Vice President Clinical Development and Operations<\/strong>\u00a0Baxalta Innovations<\/li>\n<li><strong>Acting Head Global Clinical Development<\/strong>\u00a0Baxter Bioscience<\/li>\n<li><strong>Senior Director Global Clinical Operations<\/strong>\u00a0Baxter Bioscience<\/li>\n<li><strong>Medical Director Technical Assessment Due Diligence Baxter Bioscience<\/strong><\/li>\n<li><strong>Regional Medical\/Regulatory\/Quality Director for Austria and CEE,Wyeth Whitehall Export<\/strong><\/li>\n<li><strong>Trade Law Director for Wyeth Whitehall Export and Wyeth Lederle Pharma<\/strong><\/li>\n<li><strong>Medical&amp;\/Regulatory and Pharmacovigilance Director ,Pfizer Austria<\/strong><\/li>\n<li><strong>Medical &amp; Regulatory and Pharmacovigilance Director,Pharmacia Austria<\/strong><\/li>\n<li><strong>Head Medical and\u00a0 Regulatory and Department<\/strong>\u00a0SERONO, Austria<\/li>\n<li><strong>Fellowship &#8211; Internal and Psychiatric Ward<\/strong>\u00a0University Hospital of Vienna<\/li>\n<li><strong>Research Assistant<\/strong>\u00a0Pharmacological Institute University of Vienna, Research in CNS regulation of antihypertensive drugs<\/li>\n<li><strong>Assessor Austrian Regulatory Authorities (preclinical and clinical)<\/strong><\/li>\n<\/ul>\n<p><strong>Member of the Austrian Drug Evaluation Committee (sick\u00a0 funds\/reimbursement)<\/strong><\/p>\n<ul>\n<li>Board of Austrian Pharmacological Society (APHAR)<\/li>\n<li>Task force Rare Disease Europa Bio and EBE<\/li>\n<li>Working Party Advanced Therapies<\/li>\n<li>July 2010 -2013: permanent industry representative EUCERD (EU Commission<\/li>\n<li>Working party for Rare Diseases<\/li>\n<\/ul>\n\t\t\t\t\t\t\t<img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2.jpg\" alt=\"Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2\" itemprop=\"image\" height=\"1224\" width=\"820\" title=\"Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2\" onerror=\"this.style.display='none'\"  sizes=\"auto, (max-width: 768px) 100vw, 100vw\" srcset=\"https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2.jpg 820w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-201x300.jpg 201w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-686x1024.jpg 686w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-768x1146.jpg 768w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-630x940.jpg 630w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-420x627.jpg 420w, https:\/\/www.biotechpharmasummit.com\/wp-content\/uploads\/2020\/08\/Barbara_Valenta-Singer_Fresenius_Kabi_Biotech_Pharma_Summit_2-315x470.jpg 315w\" \/>\t\t\t\t\t\t\t\n<h3>\n\tTitle: Biosimilar global development: after &gt;10years are we closer ?\n\t<\/h3>\n<ul>\n<li>FDA &#8211; EMA: how to explain and address different expectations for Equivalence margin, Confidence Interval, clinical endpoints, Reference products<\/li>\n<li>Why has interchangeability still not taken up?<\/li>\n<li>How does the practice of settlement interfere with the proposed benefits in case of interchangeability?<\/li>\n<\/ul>\n\t<a href=\"https:\/\/sociopharma.com\/\" target=\"_blank\" role=\"button\" rel=\"noopener\">\n\t\t\t\t\tPresentation available only at SocioPharma.com\n\t<\/a>\n<h4>\n\t\t\t<a href=\"#\" title=\"On the Web\" target=\"_self\" rel=\"noopener\">\n\tOn the Web\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/www.fresenius-kabi.com\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fresenius-kabi.com\/<\/a><\/p>\n<h4>\n\t\t\t<a href=\"#\" title=\"On LinkedIn\" target=\"_self\" rel=\"noopener\">\n\tOn LinkedIn\n\t\t\t<\/a>\n\t<\/h4>\n\t<p><a href=\"https:\/\/www.linkedin.com\/in\/barbara-valenta-singer-588a116\/\" target=\"_blank\" rel=\"noopener\">Visit Profile<\/a><\/p>\n\n<\/div><!-- .vgblk-rw-wrapper -->","protected":false},"excerpt":{"rendered":"<p>Barbara Valenta-Singer Chief Medical Officer Fresenius-Kabi SwissBioSim Previous work experience as Independent Clinical Consultant\u00a0Dr Barbara Valenta-Singer Consulting e.U. Vice President Clinical Development Operations\u00a0Shire ( Baxalta Acquisition) Vice President Clinical Development and Operations\u00a0Baxalta Innovations Acting Head Global Clinical Development\u00a0Baxter Bioscience Senior Director Global Clinical Operations\u00a0Baxter Bioscience Medical Director Technical Assessment Due Diligence Baxter Bioscience Regional Medical\/Regulatory\/Quality&#8230;<\/p>\n","protected":false},"author":1,"featured_media":33512,"parent":33455,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-33511","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Barbara Valenta-Singer &#8226; BioTech Pharma Summit<\/title>\n<meta name=\"description\" content=\"Previous work experience asIndependent Clinical Consultant Dr Barbara Valenta-Singer Consulting e.U.Vice President Clinical Development Operations Shire ( Baxalta Acquisition)\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biotechpharmasummit.com\/index.php\/biosimilars-biologics-2019-speakers\/barbara-valenta-singer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Barbara Valenta-Singer &#8226; 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