PADER Listings

Periodic adverse drug experience report listings are mandatory to be submitted as per stipulated timelines to USFDA. There is an online presentation of FDA regulatory which states that continuous non-submission of periodic reports is a violation (Pl refer to PADER webinar slides for further details). There certainly exists a post marketing safety guidance document which explains the detailed documents and listings for submission in periodic report.

For a large pharma company or a service provider, it is indeed a challenge to stick to these timelines with current resources in aggregate team. This not only may lead to missing the deadlines, improper review of data submitted but also may lead to erroneous listings being submitted owing to piles of documents due for periodic submission.

PvEdge provides automated PADER listings to catch up with growing requirements of the industry and the periodic listings for a huge number of medicinal products.

Using PADER listing in PvEdge, aggregate team user can:

  • Generate draft listings
  • Review the draft for case(s) qualifying for submissions
  • Generate final listings for overdose and death cases, lack of efficacy cases, periodic/expedited cases, increase in frequency report etc.
  • Apply required filters and logics to ensure accurate data output in listings
  • Ensure the case count considered for PADER listings
  • Overall significant time taken to count and consider cases becomes negligible
  • Focus on listings review instead of listings generation

The link to Webinar conducted on the topic : PADER