FDA Webinar: Postmarketing Drug Safety Compliance: 2019 Inspection Findings

FDA’s Postmarketing Adverse Drug Experience (PADE) Compliance Program monitors industry compliance with postmarketing laws and regulations for products regulated by the Center for Drug Evaluation and Research (CDER) to ensure that accurate, reliable, and timely safety data is submitted to FDA and available to reviewers who use this data to evaluate product safety.  This webinar provides an overview of the PADE Compliance Program, as well as discusses inspection findings and trends from PADE inspections completed in Fiscal Year 2019 (October 1, 2018 to September 30, 2019).

Topics Covered

• Overview of FDA’s PADE Compliance Program
• Fiscal Year 2019 PADE Inspection Site Selection
• Fiscal Year 2019 PADE Inspection Findings

Intended Audience

• Regulatory affairs professionals working in pharmacovigilance
• Application holders for approved drugs and therapeutic biologics
• Manufacturers, packers, distributors, and retailers named on product labels of prescription and over-the-counter drugs and therapeutic biologics
• Contractors, vendors, and other third parties conducting pharmacovigilance activities
• Foreign regulators
• Healthcare professionals

Learning Objectives

• Identify the role of FDA’s Postmarketing Adverse Drug Experience (PADE) Compliance Program
• Describe recent PADE inspection findings and trends

FDA Speaker

Namita Kothary, PharmD, RAC (US)
Consumer Safety Officer
Division of Enforcement and Postmarketing Safety | Office of Scientific Investigations | Office of Compliance | CDER | FDA

FDA Resources

• “Postmarketing Adverse Event Reporting Compliance Program”
• FDA Compliance Program “Postmarketing adverse drug experience reporting inspections”

Continuing Education

This course:

• SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
• has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
• has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
• Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.

Questions

Please contact info@sbiaevents.com for all technical questions.

If you’ve never used Connect Pro, get a quick overview: Adobe Connect OverviewExternal Link Disclaimer