Výsledky vyhledávání - "Krystle Pianka"

Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder

Autor: Kalindi Hapani, Nipa Parikh, Krystle Pianka, Harshil Patel

Publikováno v: Pharmaceutical Medicine. 36:173-188

Most national competent authorities issue guidance on the dissemination and implementation of additional risk minimisation measures (aRMMs), like the European Medicines Agency. However, national competent authorities guidance includes additional regu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::97dd5f9fa088ccb799903e9842d32908
https://doi.org/10.1007/s40290-022-00426-y

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Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report

Autor: Nipa Parikh, Mirza Rahman, Krystle Pianka, Jennifer Cichone, Akshay Vashist

Publikováno v: Pharmaceutical medicine. 35(5)

A Development Safety Update Report (DSUR) is a comprehensive review of safety information collected during an annual reporting period for an investigational drug. The creation of a DSUR is a resource-intensive process, requiring effective communicati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6ed22d66619f795c32f46afa83328e4
https://pubmed.ncbi.nlm.nih.gov/34519001

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Akademický článek

Abstracts.

Publikováno v: Pharmacoepidemiology & Drug Safety; Aug2019 Supplement S2, Vol. 28, p5-586, 582p

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