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Medicinal Products Lifecycle
Medical Devices
Japan Monitor (ISSN 1550-3429)
Information Meetings
Legislation and Agreements
All in Japan (ISSN 1550-3402)
E-health Japan (ISSN 1550-3410)
EU Pharma & Medical Devices
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12th ICH Immediate Briefing (Single User License)

 
12th ICH Immediate Briefing (Single User License)Quantity in Basket:none
Code: JM_I_019
Price:$50.00

 
 
 
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16-page Japan Monitor document. Single User License. Every year the regulatory and pharmaceutical authorities in Japan are organizing periodic meetings on topics such as new drug approvals, ICH, safety and QA of the pharmaceuticals and medical devices. The report on "12th ICH Immediate Briefing" held in Tokyo on June 21, 2005 is compiled and published by Jouhou Koukai Publishing. For the first time in English the program and a short summary of the proceedings, formatted, indexed, annotated and hyperlinked, editor's notes, and references. Concise summary of the proceedings of the meeting held by the Japanese regulatory authorities to announce/explain the most recent developments in the ICH process with emphasis on the Japanese participation. Key topics: pharmacopoeial interchangeability, dictionaries and data exchange, QT prolongation problem (proarrhythmic potential for non-antiarrhythmic drugs), and pharmacovigilance. Jouhou Koukai Publishing is a Jouhou Koukai business: pharmaceuticals, medical devices, drug approval, regulations, clinical trials, Japan pharmaceutical affairs, and global and Japanese regulatory affairs. Retrieval and consulting on drug approval and technical documents disclosed in Japan. (ISSN 1550-3429) Copyright JKS LLC 2005.


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