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Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions.

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Title: Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions.
Authors: Peters J; Gilead Sciences Inc., Foster City, CA, USA. jami.peters5@gilead.com., Ali AK; BeOne Medicines Ltd., San Carlos, CA, USA., Moitinho de Almeida M; GSK, Wavre, Belgium., Asao K; Kappa Medical K.K., Tokyo, Japan., Hammad TA; Takeda Development Center Americas, Inc., Cambridge, MA, USA., He X; IQVIA, Shanghai, China., Michel A; Bayer Consumer Care AG, Basel, Switzerland., Rubino A; Gilead Sciences Europe Ltd, Uxbridge, UK., Sawada S; Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan., Sobel RE; Regeneron Pharmaceuticals, Tarrytown, NY, USA., de Vogel S; Astellas Pharma Europe B.V., Leiden, The Netherlands.
Source: Drug safety [Drug Saf] 2026 Mar; Vol. 49 (3), pp. 263-271. Date of Electronic Publication: 2025 Oct 17.
Publication Type: Journal Article; Review
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions.
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  Data: <searchLink fieldCode="AU" term="%22Peters+J%22">Peters J</searchLink>; Gilead Sciences Inc., Foster City, CA, USA. jami.peters5@gilead.com.<br /><searchLink fieldCode="AU" term="%22Ali+AK%22">Ali AK</searchLink>; BeOne Medicines Ltd., San Carlos, CA, USA.<br /><searchLink fieldCode="AU" term="%22Moitinho+de+Almeida+M%22">Moitinho de Almeida M</searchLink>; GSK, Wavre, Belgium.<br /><searchLink fieldCode="AU" term="%22Asao+K%22">Asao K</searchLink>; Kappa Medical K.K., Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Hammad+TA%22">Hammad TA</searchLink>; Takeda Development Center Americas, Inc., Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22He+X%22">He X</searchLink>; IQVIA, Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Michel+A%22">Michel A</searchLink>; Bayer Consumer Care AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Rubino+A%22">Rubino A</searchLink>; Gilead Sciences Europe Ltd, Uxbridge, UK.<br /><searchLink fieldCode="AU" term="%22Sawada+S%22">Sawada S</searchLink>; Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Sobel+RE%22">Sobel RE</searchLink>; Regeneron Pharmaceuticals, Tarrytown, NY, USA.<br /><searchLink fieldCode="AU" term="%22de+Vogel+S%22">de Vogel S</searchLink>; Astellas Pharma Europe B.V., Leiden, The Netherlands.
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  Data: <searchLink fieldCode="JN" term="%229002928%22">Drug safety</searchLink> [Drug Saf] 2026 Mar; Vol. 49 (3), pp. 263-271. <i>Date of Electronic Publication: </i>2025 Oct 17.
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              Text: 2026 Mar
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