About: Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions

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An Entity of Type : schema:ScholarlyArticle, within Data Space : covidontheweb.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions
Creator	Wang, Wenquan Wang, William Ahmad, Faiz Ball, Greg Bhattacharyya, Amit Buchanan, James Duke, Susan Hendrickson, Barbara Herrero-Martinez, Esteban Jiang Phd, Qi Kurek, Raffael Li, Mengchun O'brien, Dennis Seltzer, Jonathan Tremmel, Lothar Weigel, Judith
Source	PMC
abstract	Notwithstanding successful harmonization efforts, the global regulatory framework governing product safety is complex and continually evolving, as evidenced by additional regional guidance and regulations. In this regulatory review, we provide an overview from both global and regional perspectives. A historical perspective, with a focus on recent developments, enables identification of important long–term trends, such as a shift from single–case medical review of serious adverse events to an interdisciplinary evaluation of aggregate data for the purpose of judging product causality and informing benefit–risk assessments. We will show how these trends lead to opportunities for closer interdisciplinary collaboration, for bridging the gap between preand postmarketing surveillance, and for a more proactive determination of patient populations with a positive benefit–risk profile for product use. We will conclude by pointing to ongoing and future work that seeks to provide specific solutions for ongoing aggregate safety evaluation.
has issue date	2020-01-06(xsd:dateTime)
bibo:doi	10.1007/s43441-019-00076-4
bibo:pmid	32072595
has license	no-cc
sha1sum (hex)	a6efa095bb56b8e7d79591cea86a74556e16f5e8
schema:url	https://doi.org/10.1007/s43441-019-00076-4
resource representing a document's title	Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions
has PubMed Central identifier	PMC7222952
has PubMed identifier	32072595
schema:publication	Ther Innov Regul Sci
resource representing a document's body	covid:a6efa095bb56b8e7d79591cea86a74556e16f5e8#body_text
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