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{"source_url": "http://www.globenewswire.com", "url": "http://www.globenewswire.com/news-release/2020/01/21/1973212/0/en/Regulatory-Strategies-for-Orphan-Drugs-Interactive-1-Day-Course-London-United-Kingdom-March-17-2020.html", "title": "Regulatory Strategies for Orphan Drugs: Interactive 1-Day Course (London, United Kingdom - March 17, 2020)", "top_image": "http://www.globenewswire.com/Attachment/LogoDisplay/323888?filename=323888.jpg&size=1", "meta_img": "http://www.globenewswire.com/Attachment/LogoDisplay/323888?filename=323888.jpg&size=1", "images": ["http://www.globenewswire.com/Content/Images/rss-sub.png", "http://www.globenewswire.com/Content/Images/intrado.png", "http://www.globenewswire.com/Content/Images/icon-downloadimage.gif", "http://www.globenewswire.com/Content/Images/icon-website.png", "http://www.globenewswire.com/news-release/logo/323888/0/323888.jpg?lastModified=11%2F29%2F2019%2005%3A54%3A03&size=4", "http://www.globenewswire.com/Content/Images/icon-location.png", "http://www.globenewswire.com/Attachment/LogoDisplay/323888?filename=323888.jpg&size=1", "http://www.globenewswire.com/news-release/logo/323888/0/323888.jpg?lastModified=11%2F29%2F2019%2005%3A54%3A03&size=2&v=1973212", "http://www.globenewswire.com/news-release/logo/323888/0/323888.jpg?lastModified=11%2F29%2F2019%2005%3A54%3A03&size=1"], "movies": [], "text": "Dublin, Jan. 21, 2020 (GLOBE NEWSWIRE) -- The \"Regulatory Strategies for Orphan Drugs\" conference has been added to ResearchAndMarkets.com's offering.\n\n\n\nThis must-attend new event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.\n\nThe market for orphan drug products continues to expand and developing new treatments for rare diseases is becoming an increasingly important growth area for many pharmaceutical companies. This interest in rare and orphan diseases is linked not only to the incentives offered by the different regulatory authorities but also to the recent development of advanced therapies.\n\nThe interactive course will cover all the key aspects of orphan drug legislation in both the US and EU and the regulatory processes designed to enable early access to innovative medicines. The programme will help you to assess the strategic considerations of when to apply for orphan designation and to which agency and look at the development of advanced therapies and using orphan drug designation with your ATMP strategy.\n\nA case study session on how to prepare and manage an orphan drug submission will consolidate learning and ensure that you leave the event with practical skills and knowledge that can be put to use in the workplace. The course will allow you not only to learn from our expert trainer but also to share the experiences of other delegates.\n\nBenefits of Attending\n\nGain an overview of the orphan medicinal product legislation in the EU and the US\n\nan overview of the orphan medicinal product legislation in the EU and the US Receive practical advice on how to prepare and manage orphan submissions\n\npractical advice on how to prepare and manage orphan submissions Assess strategic considerations of when to apply for orphan designation and to what agencies\n\nstrategic considerations of when to apply for orphan designation and to what agencies Discuss the use of orphan drug designation with your ATMP strategy\n\nAgenda\n\n\n\nOrphan medicinal product legislation\n\nOverview of the legislation in the EU and US\n\nWhy do we need orphan legislation?\n\nWhat the regulations say\n\nBenefits for obtaining orphan drug designation in the EU and US\n\nConsiderations for orphan drug designation Sequence of submissions by country Developing orphan versus non-orphan indications Paediatric conditions\n\n\n\nProcess of orphan drug designation\n\nOrphan drug designation in the EU Application Procedure\n\nSimilarities and differences with the US Application, procedure and incentives\n\nStrategic considerations of when to apply and to what agencies\n\nFuture collaborations between EU and US\n\nMaintenance of orphan drug designation\n\nExamples of recent orphan drug designation\n\nPrevalence challenges\n\nChanges to indication/experience of introducing a new indication\n\nPractical case study session on obtaining orphan drug designation\n\nOrphan drugs and ATMPs\n\nThe link between ATMPs and the use of orphan legislation\n\nUsing orphan drug designation with your ATMP strategy\n\nFor more information about this conference visit https://www.researchandmarkets.com/r/6nfpn8\n\nResearch and Markets also offers Custom Research services providing focused, comprehensive and tailored research.\n\nCONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900", "keywords": [], "meta_keywords": ["Research and Markets"], "tags": [], "authors": ["Research"], "publish_date": "Tue Jan 21 00:00:00 2020", "summary": "", "article_html": "", "meta_description": "Dublin, Jan. 21, 2020 (GLOBE NEWSWIRE) -- The \"Regulatory Strategies for Orphan Drugs\" conference has been added to ResearchAndMarkets.com's ...", "meta_lang": "", "meta_favicon": "/Content/Images/favicon.ico", "meta_data": {"viewport": "width=device-width, user-scalable=no, initial-scale=1, maximum-scale=1", "author": "Research and Markets", "keywords": "Research and Markets", "description": "Dublin, Jan. 21, 2020 (GLOBE NEWSWIRE) -- The \"Regulatory Strategies for Orphan Drugs\" conference has been added to ResearchAndMarkets.com's ...", "title": "Regulatory Strategies for Orphan Drugs: Interactive 1-Day Course (London, United Kingdom - March 17, 2020)", "DC.date.issued": "1/21/2020", "google-site-verification": "TPh-fYpDjXZUz98ciWasVb52qbvctqomC6zZc8vuUPU", "original-source": "http://www.globenewswire.com/news-release/2020/01/21/1973212/0/en/Regulatory-Strategies-for-Orphan-Drugs-Interactive-1-Day-Course-London-United-Kingdom-March-17-2020.html", "twitter": {"card": "summary", "site": "@globenewswire", "title": "Regulatory Strategies for Orphan Drugs: Interactive 1-Day Course (London, United Kingdom - March 17, 2020)", "description": "Dublin, Jan. 21, 2020 (GLOBE NEWSWIRE) -- The \"Regulatory Strategies for Orphan Drugs\" conference has been added to ResearchAndMarkets.com's ...", "image": "http://www.globenewswire.com/Attachment/LogoDisplay/323888?filename=323888.jpg&size=1"}, "og": {"title": "Regulatory Strategies for Orphan Drugs: Interactive 1-Day Course (London, United Kingdom - March 17, 2020)", "type": "article", "image": "http://www.globenewswire.com/Attachment/LogoDisplay/323888?filename=323888.jpg&size=1", "url": "http://www.globenewswire.com/news-release/2020/01/21/1973212/0/en/Regulatory-Strategies-for-Orphan-Drugs-Interactive-1-Day-Course-London-United-Kingdom-March-17-2020.html", "description": "Dublin, Jan. 21, 2020 (GLOBE NEWSWIRE) -- The \"Regulatory Strategies for Orphan Drugs\" conference has been added to ResearchAndMarkets.com's ...", "article": {"published_time": "1/21/2020 5:04:16 PM", "author": "Research and Markets", "tag": "Research and Markets,"}, "locale": "en_US", "site_name": "GlobeNewswire News Room"}}, "canonical_link": "https://www.globenewswire.com/news-release/2020/01/21/1973212/0/en/Regulatory-Strategies-for-Orphan-Drugs-Interactive-1-Day-Course-London-United-Kingdom-March-17-2020.html"} |
