Authoring a periodic adverse drug experience report...here's what you need to know!

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  • Additional Information
    • Subject Terms:
    • Author-Supplied Keywords:
      Periodic Adverse Drug Experience Report
      Periodic Benefit-risk Evaluation Report
      Periodic Safety Update Report
      pharmacovigilance
    • NAICS/Industry Codes:
      921190 Other General Government Support
      911910 Other federal government public administration
      912910 Other provincial and territorial public administration
      913910 Other local, municipal and regional public administration
      323111 Commercial Printing (except Screen and Books)
      323119 Other printing
      561910 Packaging and Labeling Services
    • Abstract:
      Aggregate reporting involves preparation and submission of safety reports for a given medicinal product to worldwide regulatory agencies and constitutes an essential part of safety monitoring of a medicinal product. There are specific aggregate safety reports required for a molecule in development called development safety update reports while Periodic Adverse Drug Experience Reports (PADERs) and Periodic Safety Update Reports/Periodic Benefit-risk Evaluation Reports (PBRERs) are submitted for products with marketing authorization. Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. PADERs are aggregate safety reports to be submitted to the Food and Drug Administration (FDA) for products approved for marketing in the United States (US). PADER submission starts once marketing authorization approval is received for a medicinal product by the sponsor. Quarterly and annual PADERs should be submitted within 30 and 60 days of data lock point, respectively. PADERs mainly involve presentation of case reports with serious unlisted events (15-day alert reports) in the form of narratives or in a tabular format. The present article focuses on the background, scope, structure of a PADER, and its submission timelines; lists differences between PADER and PBRER; and describes the knowledge, skills, and attitudes required for a PADER writer. [ABSTRACT FROM AUTHOR]
    • Abstract:
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    • Author Affiliations:
      1Scientific Writing and Communications, Siro Clinpharm Pvt. Ltd., Thane, Maharashtra
      2Life Sciences Learning and Development Professional, Maharashtra
    • ISSN:
      2229-3485
    • Accession Number:
      10.4103/picr.PICR_126_18
    • Accession Number:
      135781958
  • Citations
    • ABNT:
      KULKARNI, T.; KULKARNI, N. Authoring a periodic adverse drug experience report...here’s what you need to know! Perspectives in Clinical Research, [s. l.], v. 10, n. 2, p. 95–99, 2019. Disponível em: . Acesso em: 18 ago. 2019.
    • AMA:
      Kulkarni T, Kulkarni N. Authoring a periodic adverse drug experience report...here’s what you need to know! Perspectives in Clinical Research. 2019;10(2):95-99. doi:10.4103/picr.PICR_126_18.
    • APA:
      Kulkarni, T., & Kulkarni, N. (2019). Authoring a periodic adverse drug experience report...here’s what you need to know! Perspectives in Clinical Research, 10(2), 95–99. https://doi.org/10.4103/picr.PICR_126_18
    • Chicago/Turabian: Author-Date:
      Kulkarni, Tejashree, and Niranjan Kulkarni. 2019. “Authoring a Periodic Adverse Drug Experience Report...Here’s What You Need to Know!” Perspectives in Clinical Research 10 (2): 95–99. doi:10.4103/picr.PICR_126_18.
    • Harvard:
      Kulkarni, T. and Kulkarni, N. (2019) ‘Authoring a periodic adverse drug experience report...here’s what you need to know!’, Perspectives in Clinical Research, 10(2), pp. 95–99. doi: 10.4103/picr.PICR_126_18.
    • Harvard: Australian:
      Kulkarni, T & Kulkarni, N 2019, ‘Authoring a periodic adverse drug experience report...here’s what you need to know!’, Perspectives in Clinical Research, vol. 10, no. 2, pp. 95–99, viewed 18 August 2019, .
    • MLA:
      Kulkarni, Tejashree, and Niranjan Kulkarni. “Authoring a Periodic Adverse Drug Experience Report...Here’s What You Need to Know!” Perspectives in Clinical Research, vol. 10, no. 2, Apr. 2019, pp. 95–99. EBSCOhost, doi:10.4103/picr.PICR_126_18.
    • Chicago/Turabian: Humanities:
      Kulkarni, Tejashree, and Niranjan Kulkarni. “Authoring a Periodic Adverse Drug Experience Report...Here’s What You Need to Know!” Perspectives in Clinical Research 10, no. 2 (April 2019): 95–99. doi:10.4103/picr.PICR_126_18.
    • Vancouver/ICMJE:
      Kulkarni T, Kulkarni N. Authoring a periodic adverse drug experience report...here’s what you need to know! Perspectives in Clinical Research [Internet]. 2019 Apr [cited 2019 Aug 18];10(2):95–9. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=asn&AN=135781958&custid=s8280428