{"id":52506,"date":"2023-01-04T11:02:16","date_gmt":"2023-01-04T10:02:16","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/clinical-overview-and-clinical-summary-training-course-creating-effective-marketing-authorisation-applications-regulatory-guidelines-and-requirements-of-module-2-february-8-9-2023-researchandm\/"},"modified":"2023-01-04T11:02:16","modified_gmt":"2023-01-04T10:02:16","slug":"clinical-overview-and-clinical-summary-training-course-creating-effective-marketing-authorisation-applications-regulatory-guidelines-and-requirements-of-module-2-february-8-9-2023-researchandm","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/clinical-overview-and-clinical-summary-training-course-creating-effective-marketing-authorisation-applications-regulatory-guidelines-and-requirements-of-module-2-february-8-9-2023-researchandm\/","title":{"rendered":"Clinical Overview and Clinical Summary Training Course: Creating Effective Marketing Authorisation Applications &#8211; Regulatory Guidelines and Requirements of Module 2 (February 8-9, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5656624\/clinical-overview-and-clinical-summary-creating?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=bp7kl9&amp;utm_campaign=1759979+-+Clinical+Overview+and+Clinical+Summary+Training+Course%3A+Creating+Effective+Marketing+Authorisation+Applications+-+Regulatory+Guidelines+and+Requirements+of+Module+2+(February+8-9%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230104005461\/en\/1676428\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230104005461\/en\/1676428\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries.\n<\/p>\n<p>\nThe Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in Module 2 provide a critical analysis of the clinical data within the CTD.\n<\/p>\n<p>\nThe programme will provide a review of the latest information and potential future developments and cover associated documents, such as the RMP and SmPC. A practical workshop session will simulate real situations and highlight the key issues to consider when preparing the content of the written summary.\n<\/p>\n<p>\n<strong>Benefits of attending:<\/strong>\n<\/p>\n<ul>\n<li>\n<strong>Gain<\/strong> practical advice on writing clinical documents for global submissions\n<\/li>\n<li>\n<strong>Review<\/strong> the latest guidance to ensure you meet regulatory expectations\n<\/li>\n<li>\n<strong>Understand<\/strong> how to prepare separate integrated summaries of efficacy and safety for FDA\n<\/li>\n<li>\n<strong>Clarify<\/strong> the content of orphan drug applications, over-the-counter (OTC) switches, line extensions and safety-related labelling updates\n<\/li>\n<li>\n<strong>Ensure<\/strong> your risk management plan (RMP) is consistent with the Common Technical Document (CTD)\n<\/li>\n<li>\n<strong>Discuss<\/strong> the place of the clinical overview and summary in life cycle knowledge from initial IB to PSUR, and how they support the changing summary of product characteristics (SmPC)\n<\/li>\n<\/ul>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nSenior R&amp;D managers\n<\/li>\n<li>\nMembers of medical science clinical trial departments\n<\/li>\n<li>\nMedical writers\n<\/li>\n<li>\nRegulatory affairs personnel\n<\/li>\n<li>\nAll those interested in the CTD document, clinical overview and summary and its place in the evolving clinical, safety and regulatory processes\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>The CTD Guideline<\/strong>\n<\/p>\n<ul>\n<li>\nCTD modules, structure and content\n<\/li>\n<li>\nAn effective clinical overview\n<\/li>\n<li>\nThe role of the written summary\n<\/li>\n<li>\nAgency validation\n<\/li>\n<\/ul>\n<p>\n<strong>Planning content of the clinical overview<\/strong>\n<\/p>\n<ul>\n<li>\nData sources\n<\/li>\n<li>\nPresenting efficacy and safety data\n<\/li>\n<li>\nRisk management\n<\/li>\n<li>\nExpressing benefit\/risk\n<\/li>\n<li>\nComparative effectiveness\n<\/li>\n<li>\nAvoiding pitfalls\n<\/li>\n<\/ul>\n<p>\n<strong>Content of the written summary &#8211; practical considerations including a workshop<\/strong>\n<\/p>\n<ul>\n<li>\nThe document writing process<\/p>\n<ul>\n<li>\nTemplates\n<\/li>\n<li>\nStyle\n<\/li>\n<li>\nTimelines\n<\/li>\n<li>\nEfficiency\n<\/li>\n<\/ul>\n<\/li>\n<li>\nThe writing team\n<\/li>\n<li>\nEngaging and working with external writers\n<\/li>\n<li>\nGetting started, and reviewing and interpreting data\n<\/li>\n<li>\nDocument review: avoiding rework\n<\/li>\n<li>\nAchieving quality\n<\/li>\n<li>\nDocument review and approval\n<\/li>\n<\/ul>\n<p>\n<strong>Meeting regulators&#8217; expectations<\/strong>\n<\/p>\n<ul>\n<li>\nThe CTD in a global company: regional and country requirements\n<\/li>\n<li>\nIs a separate ISS or ISE necessary for an application to FDA?\n<\/li>\n<li>\nWriting for NCEs, orphan drugs, over-the-counter switches, MA renewal, generic products and line extensions\n<\/li>\n<li>\nRecent developments and their effect on producing future CTDs<\/p>\n<ul>\n<li>\nThe RMP and risk evaluation and mitigation strategy (REMS)\n<\/li>\n<\/ul>\n<\/li>\n<li>\nWriting an overview and summary to support the SmPC and labelling changes\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers<\/strong>\n<\/p>\n<p>\nJohn Price\n<\/p>\n<p>\nVice President and Head of Global Pharmacovigilance and Drug Safety\n<\/p>\n<p>\nAlexion Pharmaceuticals\n<\/p>\n<p>\nDr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology companies in North East USA planning submissions for marketing approval of oncology, haematology, renal and orphan drugs.\n<\/p>\n<p>\nHe was previously Vice President and Head of Global Pharmacovigilance and Drug Safety at Alexion Pharmaceuticals, USA.\n<\/p>\n<p>\nUntil 2014 he was VP and Head of Medical, Clinical and Regulatory Operations at Johnson and Johnson Consumer Health, USA and previously VP of Medical Documentation, Labelling and Submissions Management, Worldwide Safety and Regulatory Operations, Pfizer Inc, USA. In these roles he has led and participated in the preparation of multiple clinical overviews and summaries for MAAs, variations, renewals and labelling updates globally.\n<\/p>\n<p>\nHe is a physician trained also in clinical pharmacology who has worked in the pharmaceutical industry since 1998, including working as a consultant providing medical writing support to pharmaceutical companies and service providers. Prior to joining Pfizer he spent 7 years as medical assessor and head of the Clinical Evaluation Unit of the Post Licensing Division at the Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency).\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5656624\/clinical-overview-and-clinical-summary-creating?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=bp7kl9&amp;utm_campaign=1759979+-+Clinical+Overview+and+Clinical+Summary+Training+Course%3A+Creating+Effective+Marketing+Authorisation+Applications+-+Regulatory+Guidelines+and+Requirements+of+Module+2+(February+8-9%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/xw8iza<\/a>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;l&#x74;&#111;&#x3a;&#112;r&#x65;s&#x73;&#64;&#x72;&#101;&#x73;&#101;a&#x72;c&#x68;&#97;&#x6e;&#100;&#x6d;&#x61;r&#x6b;e&#x74;&#115;&#x2e;&#99;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#112;&#x72;&#101;&#x73;&#115;&#x40;r&#x65;s&#x65;a&#114;&#x63;&#104;&#x61;&#110;&#x64;&#109;&#x61;r&#x6b;e&#x74;s&#46;&#x63;&#111;&#x6d;<\/a><\/p>\n<p>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries. The Common Technical Document &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/clinical-overview-and-clinical-summary-training-course-creating-effective-marketing-authorisation-applications-regulatory-guidelines-and-requirements-of-module-2-february-8-9-2023-researchandm\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-52506","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical Overview and Clinical Summary Training Course: Creating Effective Marketing Authorisation Applications - Regulatory Guidelines and Requirements of Module 2 (February 8-9, 2023) - ResearchAndMarkets.com - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/clinical-overview-and-clinical-summary-training-course-creating-effective-marketing-authorisation-applications-regulatory-guidelines-and-requirements-of-module-2-february-8-9-2023-researchandm\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Overview and Clinical Summary Training Course: Creating Effective Marketing Authorisation Applications - Regulatory Guidelines and Requirements of Module 2 (February 8-9, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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This interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries. The Common Technical Document ... 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