Simulate the role of a Regulatory Affairs manager in preparing a PRBER/PSUR for a newly approved/marketed drug/device combination product. Demonstrate understanding of the relevant require

Assignment description:
In completing Assignment #3, students will have the opportunity to:
Simulate the role of a Regulatory Affairs manager in preparing a PRBER/PSUR for a newly approved/marketed drug/device combination product.
Demonstrate understanding of the relevant requirements for post-market risk: benefit profile evaluation as outlined in ICH E2C(R2) for drugs/biologics, especially in the US and EU
Demonstrate understanding of the concept of risk: benefit as it relates to drug/biologic lifecycle management and the application of pharmacovigilance as a whole.
Conceptualize of what it would be like to work cross-functionally at a small-to-midsize biotechnology company to educate coworkers on the relevant regulatory guidance for post-market PVG reporting specifically with respect to the PRBER/PSUR requirement.
Part 1: Background on Post-Market PVG
Regulatory Guidance Documents: List and describe the key Regulatory guidance documents for the US and EU that will govern how your company will be compliant with post-marketing PVG requirements. Include guidance for both drugs and devices, as this is a combination product. You should consider inclusion of documents that outline expedited reporting requirements for spontaneous ADRs, signal detection methodology, and risk mitigation strategies.
Safety Database:
You should include a description of the global PVG database, VigiBase, and show your colleagues how events for Inbrija are stored and categorized within this publicly available global PVG dataset.

Part 2: PBRER/PSUR Kickoff Meeting
Outline E2C(R2): List and describe the requirements outlined for the creation of the PBRER/PSUR. Clarify that the FDA will accept this format but outline for them the steps you need to take to get approval to use this format to fulfill your post-market NDA requirements to FDA.
In addition to providing an overview of the purpose and scope of the PBRER/PSUR, you should provide an overview of the report format and provide a brief description of the expected information in each section.

Part 3: Next Steps for the Company:
Provide your thoughts on how to bets organize the work that will be needed to write the PBRER/PSUR.
o Who will be responsible for pulling the template together?
o Is there any pre-approval documentation that you can use to help to this end?
o Who will serve as the lead project manager for the report generation and
finalization?
o Who will be responsible for generating all of the clinical data tables that need to
be included?
o How long do you think it will take to write the report from start to submission?

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