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PADER Training
PADER Training
• Objectives of PADER
• Periodicity
• PADER Sections
• Combination PADER
• Criteria for Different Section in PADER
• All the 15-day alerts (serious unlisted domestic and foreign cases) submitted during
reporting interval.
• All non-15-day alerts (serious listed, nonserious unlisted, and nonserious listed domestic
cases) reported during the reporting interval.
• Summary tabulation for all the adverse events (preferred terms as per the latest MedDRA)
by SOC for all the cases submitted to FDA for the NDA number.
• Cases where the medicinal product is reported as a co-suspect medication as well.
• Line listing of Malfunction cases
• Adverse Event by System Organ Class (Malfunction)
• Line listing of Remedial Action Cases
• Adverse Event by System Organ Class (Remedial Action)
Criteria: All the malfunction reports which are submitted to FDA for the Device-Combination Product
Note: In general, Report time frame for these cases is 30 day
• Questions
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