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The documents in question include the Developmental Safety Update Report (DSUR) which replaces the previously used Annual Safety Report (ASR), furthermore the Periodic Safety Update Report (PSUR) as well as the Risk Management Plan (RMP).
where she serves as Senior Director and is responsible for the safety of all products including patient safety information and writing annual safety reports.
Overall deaths declined to 692 compared with 855 a year earlier, according to the annual safety report by the International Air Transport Association (IATA).
The annual safety report helps improve a community's decisionmaking capabilities by presenting areas where policies need to be changed, safety has to be emphasized, assumptions need to be modified, and funding has to be increased or shifted.
He was speaking as the HSE published its annual safety report which confirmed safety figures that were announced in provisional form in September this year.
A booklet on how to sharpen knives, the kind of safety movies people were watching [but] none of the annual safety reports that the USDA was supposed to file.
Our background Our Pharmacovigilance services include: * Collection and follow-up of adverse events * Safety signed detection and analysis * Literature search execution for adverse events * Regulatory reports, including Annual Safety Reports and Periodic Safety Update Reports generation * Submission of reports to regulatory authorities * Pharmacovigilance training and quality audit We focus on high quality solutions in accordance with current regulatory and legal standards.
In August 2011, the FDA released a new guidance concerning the Development Safety Update Report (DSUR) which regulators are accepting in place of the previously required Investigational Annual Report submitted to the FDA and the EU Annual Safety Report submitted to the EU annually.