PADER Submissions, eCTD Format, FDA, eCTD Software, PAER

A Periodic Adverse Drug Experience Report (PADER / PAER) is a format in which drug companies should submit post market periodic safety reports. As regulated by the Food and Drug Administration (FDA), organizations need to submit these reports once in a quarter for three years and later, upon the US approval date, should submit these reports annually. Initially, the PADER / PAER submissions were in the combination of paper-based or electronic based submissions. But with recent mandate guides the industry to discontinue with paper format, the submissions are solely to be made in completely electronic format, i.e. in electronic Common Technical Document (eCTD).

Assisting organizations, in these scenarios, for successful PADER / PAER submissions and conversions, Freyr provides an electronic compilation of PADER and also converts existing paper-based PADER to eCTD format. As with current regulations, the PADER/PAER submission specifications include:

• PADER/PAER submissions will be added in module 5 clinical study of report of post marketing experience section i.e., m5.3.6 (report-of-post-marketing-experience), in the eCTD

• Other submission type

• External hyperlinks from module 1- cover letter to module 5.3.6 PADER document

Freyr Capabilities

• Building initial sequences and uploading them onto our smart eCTD software, Freyr SUBMIT

• PADER / PAER life cycle management

• Expert conversion skills for smooth transition to eCTD

• Full advantage of lifecycle tracking element of eCTD

• Better know-how of Life Cycle Maintenance

• Expert advice on the dossier authoring and structuring to call off the burden for creating future updates based sequences