Periodic Adverse Drug Experience Report (PADER/PAER) is a part of post-cumulative safety reports which need to be submitted to the United States Food and Drug Administration (USFDA). The main purpose of a PADER is to update and evaluate a medicineâ€™s global data and provide information about drug safety. It provides a brief summary of changing post-approval information of a drug along with the benefit-risk profile evaluation. This evaluation provides insights, whether further changes are required for a medicine's labeling or if additional investigations are required. For the initial three years, the company needs to submit the report quarterly and, thereafter, annually upon obtaining approval from the FDA. Post June 10th, 2015, PADER is accepted in electronic format with descriptive information.
Aim of A PADER
Report if any new information is obtained from the source medicine
Evaluate information to find any exposure related to the medicine
Accumulate the status of the medicineâ€™s approval across various countries and regions
It is a single pdf file with the table of contents, bookmarks, and hyperlinks
According to eCTD ICH format, PDF file should be uploaded on the node m5.3.6, in the eCTD tree hierarchy within Module â€“ 5 Clinical Study
Providing a Study Tagging File (STF) is not necessary to submit PADERâ€™s descriptive part in the eCTD format
The title of the PADER/PAER includes the reporting period whereas the leaf title follows a standard format for future submissions
PADER enables hyperlinking that will help the reviewers understand the report in an easy way
Assisting organizations, for successful PADER / PAER submissions and conversions, Freyr provides an electronic compilation of PADER and also converts existing paper-based PADER to eCTD format. For more questions regarding authoring and submission of PADER, contact our experts at email@example.com.
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