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The ICH Project will promote the review and proposal of candidate ICH strategy priorities (draft reflection papers as needed) and candidate new topics, discussion of ongoing topics, support for implementation and dissemination of new guidelines, and maintenance and updating of current guidelines.
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Although the current ICH meetings are operated in principle by face-to-face meetings, the committee will plan and propose how to efficiently promote discussions in the General Assembly, Management Committee, and Working Groups, even though some of the parties involved are forced to participate remotely.
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Cooperate in research on quality, efficacy, and safety of pharmaceuticals and medical devices aiming for international harmonization as part of the "Comprehensive Research Project for Regulatory Science of Pharmaceuticals and Medical Devices," an initiative of the Ministry of Health, Labour and Welfare (MHLW).
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As part of the dissemination of ICH results and guidelines, organize ICH immediate debriefing sessions, ICH guideline briefing sessions, etc., and support ICH-related conferences held in Japan and overseas.
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Support the dissemination of ICH guidelines to ICH and non-ICH countries involved in regulatory harmonization activities through the activities of the Training Sub-Committee established within the ICH Management Committee.
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Plan and promote global workshops to disseminate PCPI best practices targeting regulatory authorities in emerging countries in Asia and other regions, which the Pharmaceutical Manufacturers Association of Japan (PMAJ) has been working on for the past several years.
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Expand the number of Additional Support Staff (ASS) for each topic and increase opportunities for them to be involved in ICH discussions in order to further identify and train future topic leaders and rapporteur candidates.
