{"id":61980,"date":"2025-10-07T01:02:36","date_gmt":"2025-10-06T23:02:36","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/stability-testing-of-pharmaceuticals-and-biopharmaceuticals-training-course-requirements-for-new-and-existing-drug-substances-products-and-line-extensions-nov-10th-nov-11th-2025-researchandma\/"},"modified":"2025-10-07T01:02:36","modified_gmt":"2025-10-06T23:02:36","slug":"stability-testing-of-pharmaceuticals-and-biopharmaceuticals-training-course-requirements-for-new-and-existing-drug-substances-products-and-line-extensions-nov-10th-nov-11th-2025-researchandma","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/stability-testing-of-pharmaceuticals-and-biopharmaceuticals-training-course-requirements-for-new-and-existing-drug-substances-products-and-line-extensions-nov-10th-nov-11th-2025-researchandma\/","title":{"rendered":"Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course: Requirements for New and Existing Drug Substances, Products and Line Extensions (Nov 10th &#8211; Nov 11th, 2025) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6049203\/stability-testing-pharmaceuticals?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=t8kfr3&amp;utm_campaign=2093444+-+Stability+Testing+of+Pharmaceuticals+and+Biopharmaceuticals+Training+Course%3A+Requirements+for+New+and+Existing+Drug+Substances%2C+Products+and+Line+Extensions+(Nov+10th+-+Nov+11th%2C+2025)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">&#8220;Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course (Nov 10th &#8211; Nov 11th, 2025)&#8221;<\/a> training has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20251006999292\/en\/2600650\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251006999292\/en\/2600650\/22\/logo.jpg\"><\/a><br \/><a href=\"https:\/\/mms.businesswire.com\/media\/20251006999292\/en\/2600650\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20251006999292\/en\/2600650\/21\/logo.jpg\"><\/a><\/p>\n<p>\n<strong>By attending this intensive two-day seminar, delegates will learn how to:<\/strong><\/p>\n<ul>\n<li>\nCarry out appropriate stability studies and manage stability samples and facilities<\/li>\n<li>\nDesign stability studies that are suitable for global marketing<\/li>\n<li>\nIncrease the likelihood of studies receiving regulatory approval<\/li>\n<li>\nSave resources on stability testing with potential large financial savings<\/li>\n<\/ul>\n<p>\nA series of practical exercises will take place throughout the programme to give participants the opportunity to apply their knowledge under the guidance of our experienced trainers.<\/p>\n<p>\n<strong>Benefits of attending<\/strong><\/p>\n<ul>\n<li>\n<strong>Comply<\/strong> with stability requirements for new and existing drug substances, products and line extensions<\/li>\n<li>\n<strong>Gain<\/strong> knowledge on storage tests, conditions and protocols<\/li>\n<li>\n<strong>Learn<\/strong> how to design highly efficient protocols for global marketing with potentially large financial savings<\/li>\n<li>\n<strong>Discover<\/strong> how to manage stability samples and facilities<\/li>\n<li>\n<strong>Understand<\/strong> what stability testing is required following changes to a product<\/li>\n<li>\n<strong>Discuss<\/strong> data treatment, shelf-life assignment and extrapolation<\/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>Who Should Attend:<\/strong><\/p>\n<p>\n<strong>Personnel involved in:<\/strong><\/p>\n<ul>\n<li>\nStability testing of pharmaceuticals and biopharmaceuticals<\/li>\n<li>\nThe design of stability protocols<\/li>\n<li>\nThe management of stability samples and facilities<\/li>\n<li>\nThe development of pharmaceuticals which require stability testing<\/li>\n<li>\nThe production of regulatory documents which include stability data<\/li>\n<li>\nQuality assurance<\/li>\n<\/ul>\n<p>\n<strong>Key Topics Covered:<\/strong><\/p>\n<p>\n<strong>Background to stability testing and guidelines<\/strong><\/p>\n<ul>\n<li>\nThe rationale for stability testing<\/li>\n<li>\nRelevant guidelines<\/li>\n<\/ul>\n<p>\n<strong>Storage tests, conditions and protocols<\/strong><\/p>\n<ul>\n<li>\nTests for drug substance and product types<\/li>\n<li>\nStorage conditions and periods required<\/li>\n<li>\nTypical protocols<\/li>\n<li>\nDeveloping global stability protocols<\/li>\n<li>\nIn-use testing<\/li>\n<\/ul>\n<p>\n<strong>Exercise 1: Designing a simple stability protocol<\/strong><\/p>\n<p>\n<strong>Management of stability samples and facilities<\/strong><\/p>\n<ul>\n<li>\nSample management<\/li>\n<li>\nValidation of storage facilities<\/li>\n<li>\nHow to treat excursions from condition<\/li>\n<\/ul>\n<p>\n<strong>Requirements for existing products, line extensions and variations<\/strong><\/p>\n<ul>\n<li>\nGuidelines available (ICH, EU and USA)<\/li>\n<li>\nRequirements for active ingredient<\/li>\n<li>\nRequirements for product<\/li>\n<li>\nRequirements for variations to marketed products<\/li>\n<\/ul>\n<p>\n<strong>Exercise 2: Designing a more complex stability protocol<\/strong><\/p>\n<p>\n<strong>Data treatment, shelf-life assignment and extrapolation<\/strong><\/p>\n<ul>\n<li>\nWhen is statistical treatment required?<\/li>\n<li>\nHow much extrapolation beyond real-time data is allowable?<\/li>\n<li>\nPresentation of data in submissions<\/li>\n<li>\nSetting shelf-life specifications<\/li>\n<\/ul>\n<p>\n<strong>Exercise 3: Data treatment<\/strong><\/p>\n<p>\n<strong>Light stability testing<\/strong><\/p>\n<ul>\n<li>\nICH Q1B guidelines<\/li>\n<li>\nLight sources<\/li>\n<li>\nRequired exposure<\/li>\n<li>\nProblems in light testing<\/li>\n<\/ul>\n<p>\n<strong>Packaging considerations<\/strong><\/p>\n<ul>\n<li>\nGuidelines<\/li>\n<li>\nRequirements when changing packaging<\/li>\n<li>\nDemonstrating equivalence<\/li>\n<li>\nPermeation considerations<\/li>\n<li>\nInteraction studies<\/li>\n<\/ul>\n<p>\n<strong>Exercise 4: Packaging<\/strong><\/p>\n<p>\n<strong>Biopharmaceutical stability<\/strong><\/p>\n<ul>\n<li>\nICH Q5C and regulatory guidance<\/li>\n<li>\nComplexity associated with biopharmaceuticals<\/li>\n<li>\nStability-indicating assays for biopharmaceuticals<\/li>\n<li>\nStability considerations for new modalities<\/li>\n<\/ul>\n<p>\n<strong>Sundry considerations<\/strong><\/p>\n<ul>\n<li>\nBulk stability<\/li>\n<li>\nManufacture in zones III\/IV to be sold in zone I<\/li>\n<li>\nOut-of-specification in stability<\/li>\n<\/ul>\n<p>\n<strong>Matrixing and bracketing stability studies<\/strong><\/p>\n<ul>\n<li>\nBracketing designs<\/li>\n<li>\nMatrixing designs<\/li>\n<li>\nICH Q1D guidelines<\/li>\n<li>\nWhat is acceptable for bracketing and matrixing?<\/li>\n<\/ul>\n<p>\n<strong>Exercise 5: Designing efficient stability protocols<\/strong><\/p>\n<p>\nFor more information about this training visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/6049203\/stability-testing-pharmaceuticals?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=t8kfr3&amp;utm_campaign=2093444+-+Stability+Testing+of+Pharmaceuticals+and+Biopharmaceuticals+Training+Course%3A+Requirements+for+New+and+Existing+Drug+Substances%2C+Products+and+Line+Extensions+(Nov+10th+-+Nov+11th%2C+2025)&amp;utm_exec=chdomspi\" rel=\"nofollow\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/ie2wgi<\/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=\"&#x6d;&#97;&#105;&#x6c;&#x74;&#111;&#58;&#x70;&#x72;&#101;&#115;&#x73;&#x40;&#114;&#101;&#x73;&#x65;&#97;&#114;&#x63;&#x68;&#97;&#110;&#x64;&#x6d;&#97;&#114;&#x6b;&#x65;&#116;&#115;&#x2e;&#x63;&#111;&#109;\" rel=\"nofollow\" shape=\"rect\">&#112;r&#x65;s&#x73;&#64;&#x72;&#101;&#x73;&#101;&#x61;&#114;c&#x68;a&#x6e;d&#x6d;&#97;&#x72;&#107;&#x65;&#116;&#x73;&#46;c&#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;Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course (Nov 10th &#8211; Nov 11th, 2025)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. By attending this intensive two-day seminar, delegates will learn how to: Carry out appropriate stability studies and manage stability samples and facilities Design stability studies that are suitable for global marketing Increase &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/stability-testing-of-pharmaceuticals-and-biopharmaceuticals-training-course-requirements-for-new-and-existing-drug-substances-products-and-line-extensions-nov-10th-nov-11th-2025-researchandma\/\">[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-61980","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>Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course: Requirements for New and Existing Drug Substances, Products and Line Extensions (Nov 10th - Nov 11th, 2025) - 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\/stability-testing-of-pharmaceuticals-and-biopharmaceuticals-training-course-requirements-for-new-and-existing-drug-substances-products-and-line-extensions-nov-10th-nov-11th-2025-researchandma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course: Requirements for New and Existing Drug Substances, Products and Line Extensions (Nov 10th - Nov 11th, 2025) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Stability Testing of Pharmaceuticals and Biopharmaceuticals Training Course (Nov 10th &#8211; Nov 11th, 2025)&#8221; training has been added to ResearchAndMarkets.com&#8217;s offering. 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By attending this intensive two-day seminar, delegates will learn how to: Carry out appropriate stability studies and manage stability samples and facilities Design stability studies that are suitable for global marketing Increase ... 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