100+ Pediatric medicines PowerPoint (PPT) Presentations, Pediatric medicines PPTs

Pediatric medicines - PowerPoint PPT Presentation

ICH Q10/WHO TRS A Regulatory Perspective

ICH Q10/WHO TRS A Regulatory Perspective. Presentation by: Dr. A. Ramkishan Asst. Drugs Controller (India) Govt. of India. Contents of Presentation. Introduction History of WHO GMP TRS guidelines A Unique approach for ICH ICH Quality Vision GMPs & ICH Structure & Content of ICH

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738 views • 45 slides

Reports and Intelligence: Pediatric drug development

Although pediatrics represent around two-fifths of the global population the market for pediatric medicines remains relatively small (accounting for <10% of global pharmaceutical sales). Until pediatric legislation was introduced in the US (1997) and EU (2007) there has been little incentive for the pharma industry to evaluate drugs in children due to the low medical need of chronic illnesses and the high off-label use of generic drugs (Milne & Bruss, 2008). Detailed report at: http://www.reportsandintelligence.com/pediatric-drug-development-regulatory-challenges-and-commercial-opportunities-market

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276 views • 7 slides

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Pediatric medicines - PowerPoint PPT Presentation

ICH Q10/WHO TRS A Regulatory Perspective

Reports and Intelligence: Pediatric drug development