The October 2022 updates to the Chapter 53 of the FDAs Post-marketing Adverse Drug Experience (PADE) Inspection Manual resulted in a few key changes. We’ve helped our clients prepare, oftentimes mobilizing not only within PV, but across cross-functional partners (ex. MedInfo, Quality, Marketing, Regulatory, & Legal).
While PADE inspections build upon the successes (or shortcomings) of a company’s Clinically-focused Bioresearch Monitoring (BIMO) pre-approval inspections, preparing for PADE inspection is a separate effort that requires dedicated attention by the Head of Drug Safety.
Inspection readiness efforts are a great way to ensure your organization and partners have built post-market safety systems that are compliant as inspections can occur as early as 6 months post-launch.
What is a PADE Inspection?
“PADE Inspections monitor industry compliance with post-marketing safety laws and regulations for human drugs and therapeutic biologics. They ensure that accurate, reliable, and timely safety data are submitted correctly to FDA.”
Why is it important?
FDA’s PADE inspections ensure adherence to FDA reporting obligations and verify compliance to newly revised guidelines, updated in October 2022
What to expect?
The FDA conducts a complete assessment of procedures, systems, records, and processes involved in evaluating, reporting, and submitting adverse drug events
What steps can you take to ensure readiness?
Its important to establish a robust and compliant safety system early in Phase 2/3. As you near product launch, companies can build upon their existing processes to prepare for post-market activities and be inspection ready
Need support with your inspection readiness plan?
Partner with SSI to adhere to the newly revised PADE Inspection Manual and ensure “accurate, reliable, and timely” safety processes
In 2019, 44% of PADE inspections occurred at companies that had no prior PADE inspection- if you have a post-marketed product and have yet to undergo a PADE inspection, it’s very probable you will be inspected soon. Other common triggers for inspections are if your organization has recently experienced corporate changes, additions to marketed product portfolios (especially any novel therapy types) or if they’ve had not prior PADE Inspections.
As with any inspection readiness effort, it requires coordination, documentation and engagement of cross-functional team members to ensure compliance. Preparation for Inspection Readiness activities can occur especially in busy times of rapid change- usually in the 6-8 months leading up to and directly after product launch. Having a dedicated inspection readiness team will ensure that this remains a priority.
To help you get started in preparing, here are some Dos & Donts PADE Inspection
To make your Inspection Readiness efforts run smoothly, SSI has a toolkit and team of experienced subject matter experts that can work amongst your team to ensure you are prepared and ready for the FDA. Reach out or submit an inquiry.