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RGA6212 Fall 2020: Preparing a Periodic Risk-Benefit Evaluation Report (PRBER; also known as Periodic Safety Update Report or PSUR)
Assignment description:
In completing Assignment #3, Group Presentation for RGA6212, 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

As with assignment numbers 1 and 2, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company that has successfully developed a new, inhaled treatment for Parkinson’s Disease, called Inbrija. Your company is very small but despite this, the company has successfully obtained FDA and EMA approval to market Inbrijawithin the United States and EU!
As a seasoned Regulatory Affairs professional, you are aware that your company will need to continue to evaluate the Risk: Benefit profile of Inbrija while it launches into the global marketplace. A mandatory requirement in the US and EU is for the submission of the PRBER/PSUR which will include an in-depth analysis of the current Risk: Benefit profile for Inbrija. The new product has been on the market for just under a year and the International Birth Date (IBD) of the approval is on the horizon. You will use the IBD to trigger the timing of the submission of your PRBER/PSUR to the US and EU authorities.

  1. Part 1: Background on Post-Market PVG
  1. 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.
  2. 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.

Requirements: 3 pages long

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