Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities
Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successf...
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| Format: | Article |
| Language: | English |
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MDPI AG
2013-03-01
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| Series: | Pharmaceutics |
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| Online Access: | http://www.mdpi.com/1999-4923/5/1/168 |
| _version_ | 1828395121394057216 |
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| author | Robert L. Davis |
| author_facet | Robert L. Davis |
| author_sort | Robert L. Davis |
| collection | DOAJ |
| description | Since the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an “industrialized process” approach and (vi) political safe harbor. |
| first_indexed | 2024-12-10T08:07:15Z |
| format | Article |
| id | doaj.art-fa00e45ee48e47449162ed9122ed9f74 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-12-10T08:07:15Z |
| publishDate | 2013-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-fa00e45ee48e47449162ed9122ed9f742022-12-22T01:56:39ZengMDPI AGPharmaceutics1999-49232013-03-015116817810.3390/pharmaceutics5010168Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis CapabilitiesRobert L. DavisSince the late 1990s, there have been tremendous strides made in improving the capacity for carrying out routine active surveillance of new vaccines in the United States. These strides have led to new surveillance systems that are now in place. Some of the critical elements that are part of successful vaccine or drug safety surveillance systems include their use of (i) longitudinal data from a discrete enumerated population base, (ii) frequent, routine transfers of small amounts of data that are easy to collect and collate, (iii) avoidance of mission creep, (iv) statistical capabilities, (v) creation of an “industrialized process” approach and (vi) political safe harbor.http://www.mdpi.com/1999-4923/5/1/168vaccine safety, drug safety, surveillance |
| spellingShingle | Robert L. Davis Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities Pharmaceutics vaccine safety, drug safety, surveillance |
| title | Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities |
| title_full | Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities |
| title_fullStr | Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities |
| title_full_unstemmed | Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities |
| title_short | Vaccine Safety Surveillance Systems: Critical Elements and Lessons Learned in the Development of the US Vaccine Safety Datalink’s Rapid Cycle Analysis Capabilities |
| title_sort | vaccine safety surveillance systems critical elements and lessons learned in the development of the us vaccine safety datalink s rapid cycle analysis capabilities |
| topic | vaccine safety, drug safety, surveillance |
| url | http://www.mdpi.com/1999-4923/5/1/168 |
| work_keys_str_mv | AT robertldavis vaccinesafetysurveillancesystemscriticalelementsandlessonslearnedinthedevelopmentoftheusvaccinesafetydatalinksrapidcycleanalysiscapabilities |