{"id":62434,"date":"2026-01-02T19:05:51","date_gmt":"2026-01-02T18:05:51","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/successful-medical-writing-from-protocol-to-ctd-training-course-understand-international-guidelines-and-standards-mar-23rd-mar-24th-2026-researchandmarkets-com\/"},"modified":"2026-01-02T19:05:51","modified_gmt":"2026-01-02T18:05:51","slug":"successful-medical-writing-from-protocol-to-ctd-training-course-understand-international-guidelines-and-standards-mar-23rd-mar-24th-2026-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/successful-medical-writing-from-protocol-to-ctd-training-course-understand-international-guidelines-and-standards-mar-23rd-mar-24th-2026-researchandmarkets-com\/","title":{"rendered":"Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd &#8211; Mar 24th, 2026) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6031780\/successful-medical-writing-protocol-ctd?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=7czt96&amp;utm_campaign=2125326+-+Successful+Medical+Writing+from+Protocol+to+CTD+Training+Course%3A+Understand+International+Guidelines+and+Standards+(Mar+23rd+-+Mar+24th%2C+2026)+&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">&#8220;Successful Medical Writing &#8211; from Protocol to CTD Training Course (Mar 23rd &#8211; Mar 24th, 2026)&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20260102173967\/en\/2680802\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260102173967\/en\/2680802\/22\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20260102173967\/en\/2680802\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260102173967\/en\/2680802\/21\/logo.jpg\"><\/a><\/p>\n<p>\n<strong>Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals<\/strong>.<\/p>\n<p>\nThis process largely relies on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome. This intensive three-day medical writing course will help you to improve your skills and achieve this standard.<\/p>\n<p>\n<strong>Who Should Attend:<\/strong><\/p>\n<p>\nThe course will be of interest to all those in the pharmaceutical industry who prepare research reports and documentation intended for regulatory authorities. Although the focus of the seminar is on clinical research, many of the principles will also apply to other types of reports, including pre-clinical, CMC and veterinary documentation. The practical training will benefit not only those new to medical writing, but also those wishing to perfect their existing writing skills, including full-time medical writers and those who only occasionally write research documentation or regulatory submissions.<\/p>\n<p>\n<strong>Benefits of attending<\/strong><\/p>\n<ul>\n<li>\n<strong>Gain <\/strong>in-depth knowledge on general writing and data presentation skills, specifically in the kind of documents most frequently encountered in clinical research<\/li>\n<li>\n<strong>Understand <\/strong>the international guidelines and standards<\/li>\n<li>\n<strong>Explore <\/strong>both the theoretical and practical aspects of writing for regulatory authorities through illustrative examples<\/li>\n<\/ul>\n<p>\n<strong>Certifications<\/strong><\/p>\n<ul>\n<li>\nCPD: 12 hours for your records<\/li>\n<li>\nCertificate of completion<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong><\/p>\n<p>\n<strong>Day 1 &#8211; Fundamentals of Regulatory Medical Writing<\/strong><\/p>\n<p>\n<strong>Introduction to Regulatory Medical Writing<\/strong><\/p>\n<ul>\n<li>\nOverview of medical writing in the pharmaceutical industry<\/li>\n<li>\nTypes of documents<\/li>\n<li>\nProject management<\/li>\n<li>\nWorking cross-functionally<\/li>\n<li>\nDocument reviews<\/li>\n<li>\nQuality checks<\/li>\n<\/ul>\n<p>\n<strong>Regulatory environment and guidelines<\/strong><\/p>\n<ul>\n<li>\nRegulatory agencies and key regulatory guidelines<\/li>\n<li>\nDrug development lifecycle and regulatory milestones<\/li>\n<\/ul>\n<p>\n<strong>Regulatory documents<\/strong><\/p>\n<ul>\n<li>\nWhat are they and why are they needed?<\/li>\n<li>\nDeveloping the protocol and ICFs<\/li>\n<li>\nDeveloping the CSR<\/li>\n<li>\nDeveloping the Investigator&#8217;s Brochure<\/li>\n<li>\nDeveloping the DSUR<\/li>\n<\/ul>\n<p>\n<strong>Day 2 &#8211; Scientific Advice and Marketing Applications<\/strong><\/p>\n<p>\n<strong>Briefing documents<\/strong><\/p>\n<ul>\n<li>\nWhat are they?<\/li>\n<li>\nWhy are they needed?<\/li>\n<li>\nHow are they developed?<\/li>\n<\/ul>\n<p>\n<strong>Importance of real-world evidence and patient-centred outcomes<\/strong><\/p>\n<p>\n<strong>The Common Technical Document<\/strong><\/p>\n<ul>\n<li>\nIntroduction to clinical submission dossiers<\/li>\n<li>\nWriting the clinical overview &amp; the clinical summary<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong><\/p>\n<p>\nCheryl Roberts-Vitalis<br \/>\n<br \/>BioMarin Pharmaceutical Inc.<\/p>\n<p>\nCheryl is currently the Global Head of Medical Writing at BioMarin Pharmaceutical Inc., and specialises in medical writing for serious and life-threatening rare diseases. She joined the pharmaceutical industry in 2001 in drug development, and continued in positions in medical editing and medical writing in both the pharmaceutical and consultancy industry. She holds a degree in Medical Biology and a Masters in Neuroscience. Cheryl has been an approved workshop leader for the European Medical Writers Association since 2015 and gives training on subgroup analyses and orphan medicinal products.<\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6031780\/successful-medical-writing-protocol-ctd?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=7czt96&amp;utm_campaign=2125326+-+Successful+Medical+Writing+from+Protocol+to+CTD+Training+Course%3A+Understand+International+Guidelines+and+Standards+(Mar+23rd+-+Mar+24th%2C+2026)+&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/2lk8xk<\/a><\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong><\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.<\/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=\"&#109;&#x61;i&#108;&#x74;o&#58;&#x70;r&#101;&#x73;s&#64;&#x72;&#101;&#x73;&#x65;&#97;&#x72;&#x63;&#104;&#x61;n&#100;&#x6d;a&#114;&#x6b;e&#116;&#x73;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow\" shape=\"rect\">&#112;&#x72;e&#x73;&#x73;&#64;&#x72;e&#x73;&#x65;&#97;&#x72;c&#x68;&#x61;&#110;&#x64;m&#x61;&#x72;&#107;&#x65;t&#x73;&#x2e;&#99;&#x6f;m<\/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<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Successful Medical Writing &#8211; from Protocol to CTD Training Course (Mar 23rd &#8211; Mar 24th, 2026)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. Success in the pharmaceutical industry depends on the speed and efficiency of new drug approvals. This process largely relies on the quality of documentation submitted to the regulatory authorities, and &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/successful-medical-writing-from-protocol-to-ctd-training-course-understand-international-guidelines-and-standards-mar-23rd-mar-24th-2026-researchandmarkets-com\/\">[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-62434","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd - Mar 24th, 2026) - 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\/successful-medical-writing-from-protocol-to-ctd-training-course-understand-international-guidelines-and-standards-mar-23rd-mar-24th-2026-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Successful Medical Writing from Protocol to CTD Training Course: Understand International Guidelines and Standards (Mar 23rd - Mar 24th, 2026) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Successful Medical Writing &#8211; from Protocol to CTD Training Course (Mar 23rd &#8211; Mar 24th, 2026)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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