{"id":52509,"date":"2023-01-04T12:02:26","date_gmt":"2023-01-04T11:02:26","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pharmaceutical-development-of-atmps-advanced-therapy-medicinal-products-training-course-february-6-9-2023-researchandmarkets-com\/"},"modified":"2023-01-04T12:02:26","modified_gmt":"2023-01-04T11:02:26","slug":"pharmaceutical-development-of-atmps-advanced-therapy-medicinal-products-training-course-february-6-9-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pharmaceutical-development-of-atmps-advanced-therapy-medicinal-products-training-course-february-6-9-2023-researchandmarkets-com\/","title":{"rendered":"Pharmaceutical Development of ATMPs (Advanced Therapy Medicinal Products) Training Course (February 6-9, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5656656\/pharmaceutical-development-of-atmps-training?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=cxtcn4&amp;utm_campaign=1759986+-+Pharmaceutical+Development+of+ATMPs+(Advanced+Therapy+Medicinal+Products)+Training+Course+(February+6-9%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Pharmaceutical Development of ATMPs 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\/20230104005463\/en\/1676431\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230104005463\/en\/1676431\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThis course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs).\n<\/p>\n<p>\nIndustry experts will cover the regulatory landscape and the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges.\n<\/p>\n<p>\nThe differences between GMP for ATMPs and conventional therapies will be discussed, as will the requirements for clinical trials and the preparation of the IMPD. Advice on the specific transportation requirements of these products will also be addressed.\n<\/p>\n<p>\nThis programme will be of benefit to all those involved with or considering developing an ATMP.\n<\/p>\n<p>\n<strong>Benefits of attending:<\/strong>\n<\/p>\n<ul>\n<li>\n<strong>Understand<\/strong> the GMP requirements for clinical trials in the US and Europe\n<\/li>\n<li>\n<strong>Gain<\/strong> a practical insight into other markets\n<\/li>\n<li>\n<strong>Determine<\/strong> critical quality attributes\n<\/li>\n<li>\n<strong>Develop<\/strong> a successful QC strategy\n<\/li>\n<li>\n<strong>Examine<\/strong> the major differences between GMP for ATMPs and conventional therapies\n<\/li>\n<li>\n<strong>Overcome<\/strong> potential pitfalls when manufacturing cells\n<\/li>\n<li>\n<strong>Discuss<\/strong> multi-manufacturing sites for autologous products\n<\/li>\n<li>\n<strong>Consider<\/strong> stability issues\n<\/li>\n<li>\n<strong>Examine<\/strong> risk analysis for biological materials and understand Annex 16\n<\/li>\n<li>\n<strong>Gain<\/strong> an introduction to GMO approval requirements\n<\/li>\n<\/ul>\n<p>\nThis seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.\n<\/p>\n<p>\n<strong>Who Should Attend:<\/strong>\n<\/p>\n<ul>\n<li>\nR&amp;D personnel involved in research on cell or gene-based therapies\n<\/li>\n<li>\nManagers involved in the development and manufacture of ATMPs\n<\/li>\n<li>\nQuality assurance and quality control personnel responsible for quality aspects of ATMPs\n<\/li>\n<li>\nGMP managers responsible for implementing GMP in ATMP manufacture\n<\/li>\n<li>\nRegulatory personnel involved in inspections of ATMPs\n<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Introduction to ATMPs<\/strong>\n<\/p>\n<ul>\n<li>\nDefinition of ATMPs and associated terms\n<\/li>\n<li>\nClassification of ATMPs\n<\/li>\n<\/ul>\n<p>\n<strong>The Regulatory Landscape<\/strong>\n<\/p>\n<ul>\n<li>\nExamining the European regulatory landscape for ATMPs &#8211; detailed analysis of existing regulation 1394\/2007\n<\/li>\n<li>\nConsidering factors lying outside of the regulation&#8217;s scope, e.g. combination products\n<\/li>\n<li>\nLinks to related directives, eg Tissues and Cells Directives (2002\/98\/EC and 2004\/23\/EC); Medical Device Directive (93\/42\/EEC) and forthcoming regulation\n<\/li>\n<\/ul>\n<p>\n<strong>Strategic Considerations<\/strong>\n<\/p>\n<ul>\n<li>\nOpportunities to meet with regulators to maximise approval chances\n<\/li>\n<li>\nATMP-specific options in the EU: certification procedure, risk-benefit approach\n<\/li>\n<li>\nAccelerated access opportunities in EU and US\n<\/li>\n<li>\nUnderstanding breakthrough status\/PRIME\n<\/li>\n<\/ul>\n<p>\n<strong>Insight into Global Regulations and Requirements<\/strong>\n<\/p>\n<ul>\n<li>\nExamining key markets including Europe, US and Japan\n<\/li>\n<li>\nEvaluate the regulatory differences between regions to help you build a strategic approval route\n<\/li>\n<li>\nGMP requirements at Phase I in US and Europe &#8211; ramifications for your product\n<\/li>\n<\/ul>\n<p>\n<strong>Overcoming Quality Challenges<\/strong>\n<\/p>\n<ul>\n<li>\nOverview of frequent quality concerns\n<\/li>\n<li>\nPotency assay development\n<\/li>\n<li>\nDetermining critical quality attributes\n<\/li>\n<li>\nDeveloping a successful QC strategy for short-shelf-life product\n<\/li>\n<li>\nQP release: timing and logistical challenges for ATMPs\n<\/li>\n<\/ul>\n<p>\n<strong>Understanding Clinical Trials<\/strong>\n<\/p>\n<ul>\n<li>\nEU clinical trial requirements\n<\/li>\n<li>\nThe US IND\n<\/li>\n<\/ul>\n<p>\n<strong>Risk-Based Approach for ATMPs<\/strong>\n<\/p>\n<ul>\n<li>\nExamining 3.2.A Adventitious Agents\n<\/li>\n<li>\nLevel of data required EU\/US\n<\/li>\n<\/ul>\n<p>\n<strong>GMP for ATMPs<\/strong>\n<\/p>\n<ul>\n<li>\nWhat is required: examine the major differences between GMP for ATMPs and conventional therapies\n<\/li>\n<li>\nOvercoming potential pitfalls when manufacturing cells\n<\/li>\n<li>\nCurrent GMP interpretations\n<\/li>\n<li>\nMultiple manufacturing sites for autologous products\n<\/li>\n<li>\nPoint-of-care preparation devices\n<\/li>\n<\/ul>\n<p>\n<strong>Stability and Logistics<\/strong>\n<\/p>\n<ul>\n<li>\nConsidering stability issues\n<\/li>\n<li>\nChallenges in transporting cell therapies\/cryopreservation\n<\/li>\n<li>\nPreparation on site\n<\/li>\n<\/ul>\n<p>\n<strong>Clinical Trial Considerations<\/strong>\n<\/p>\n<ul>\n<li>\nOptimising materials for regulatory compliance &#8211; vendor qualification\n<\/li>\n<li>\nRisk analysis for biological materials\n<\/li>\n<li>\nThe comparability concept and its importance in preparing for clinical trials\n<\/li>\n<li>\nIntroduction to GMO approval requirements\n<\/li>\n<\/ul>\n<p>\n<strong>Practical Considerations for the IMPD<\/strong>\n<\/p>\n<ul>\n<li>\nTerms and definitions\n<\/li>\n<li>\nGuidance on IMPD content for ATMPs\n<\/li>\n<li>\nData requirements for first-in-human vs later clinical trials\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers<\/strong>\n<\/p>\n<p>\nAndrew Willis\n<\/p>\n<p>\nConsultant\n<\/p>\n<p>\nIndependent\n<\/p>\n<p>\nAndrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs &amp; Consulting Services. Catalent is the world&#8217;s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis.\n<\/p>\n<p>\nHe has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.\n<\/p>\n<p>\nHe has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5656656\/pharmaceutical-development-of-atmps-training?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=cxtcn4&amp;utm_campaign=1759986+-+Pharmaceutical+Development+of+ATMPs+(Advanced+Therapy+Medicinal+Products)+Training+Course+(February+6-9%2C+2023)&amp;utm_exec=chdo54prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/1kd9s5<\/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=\"m&#97;&#105;&#108;&#x74;&#x6f;&#x3a;pr&#101;&#115;&#x73;&#x40;&#x72;&#x65;se&#97;&#114;&#x63;&#x68;&#x61;&#x6e;d&#109;&#97;&#114;&#x6b;&#x65;&#x74;s&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#x72;&#101;&#115;&#115;&#64;&#x72;&#x65;&#x73;&#101;&#97;rc&#x68;&#x61;&#x6e;&#100;&#109;a&#x72;&#x6b;&#x65;&#116;&#115;&#46;c&#x6f;&#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;Pharmaceutical Development of ATMPs Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs). Industry experts will cover the regulatory landscape and the definition and &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/pharmaceutical-development-of-atmps-advanced-therapy-medicinal-products-training-course-february-6-9-2023-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-52509","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>Pharmaceutical Development of ATMPs (Advanced Therapy Medicinal Products) Training Course (February 6-9, 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\/pharmaceutical-development-of-atmps-advanced-therapy-medicinal-products-training-course-february-6-9-2023-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmaceutical Development of ATMPs (Advanced Therapy Medicinal Products) Training Course (February 6-9, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Pharmaceutical Development of ATMPs Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. This course has been designed to provide a comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs). Industry experts will cover the regulatory landscape and the definition and ... 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