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 medicine’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 medicine’s approval across various countries and regions

PADER Specifications

  • 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 – 5 Clinical Study
  • Providing a Study Tagging File (STF) is not necessary to submit PADER’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 sales@freyrsolutions.com.