Questions & Answers Blog on recent webinar on ‘Solution to Periodic Safety Submissions Reports (PADER/PAER) in eCTD’
These are few of the questions raised by Webinar audience regarding Periodic Safety Submissions Reports (PADER/PAER) in eCTD
Q 1. Is ICSR so called MedWatch Forms?
Ans. ICSRs are Individual case safety reports that carries information on adverse event(s) reported for drug and can be submitted in XML format. MedWatch is FDA Form 3500A, a reporting form for submission of suspected adverse events to USFDA i.e., it is a format that is accepted by US regulatory authority. For more information on ICSRs, please refer to ICH-E2B (R2) guidance – Data elements for transmission of Individual case safety reports.
Q 2. Can you show an example of what ICSR looks like in a XML format to be sent to FDA?
Ans. We have a pharmacovigilance database which does E2B-XML submissions (ICSRs submission in XML format). Unfortunately we cannot share the format example, however, you can refer to further information for XML in guidance document, and go to pvnet.in for futher details of preparation of xml file. It is a solution of pharmacovigilance.The link for the guidance document:
Q3. pls highlight on how it will help in signal detection in terms on ectd?
Signal detection activity is performed to identify any signal arising from potential ICSRs in the pharmacovigilance database. Signals are routinely monitored for all products in the portfolio including those which are under active surveillance (e.g., newly marketed products, products with newly approved indications, product requiring monitoring as per regulatory norms etc.). Signals management is a pivotal activity and a subset of the vast pharmacovigilance science.
Q 4.Currently our firm is still submitting MedWatch Forms in paper. When is the deadline that FDA requires submit them in XML (thru E2B)? Is it Sept 6th 2015?
PvNET database at Sarjen generates automated MedWatch forms and E2B-XML reports based on data entered in case processing. Different report formats are generated after single case entry for fulfilling submission requirements of different countries.
Q5. If we have one product with multiple doses do we need to have different PADER for each doses of same product?
Ans. No, if you have submitted only one dossier for multiple doses then you have to submit only one PADER/PAER submission in eCTD format
Q6. What are submission type used for PADER/PAER submission in eCTD format?
Ans. “Other” is used for submission type for PADER/PAER in the eCTD format.
Q7. Should be provide STF in Module 5.3.6 for PADER/PAER submission in eCTD format?
Ans. You can use PDF and STF, but providing STF on 5.3.6 for PADER /PAER submission not necessary.
Note: – According to ICH guideline for eCTD in Module 4 and 5 required STF for clinical data, you can directly upload Descriptive-info.pdf on the node without creating STF, but would give a medium level warning while validating of dossier, warning would be: A file has been submitted in a study section without providing an STF file, which can be ignored.
