Certara was engaged to assist a client with preparing a last-minute addition to a Periodic Safety Update Report (PSUR). During the process, Certara’s experts identified the need to prepare an additional 2-year PSUR to ensure compliance with the competent authority in another regulatory region.
In this case study, we examine how we collaborated with the client to ensure both documents were properly synchronized and submitted to their respective regions in alignment with PSUR reporting timelines.
The Challenge
The last-minute addition of the 2-year PSUR was not initially foreseen by the client. Both PSURs shared the same data lock point and required collaboration with the same client teams, creating significant challenges:
- Data Access and Review Bottlenecks: The overlap in timelines meant that sourcing data and performing necessary reviews would be a challenge.
- Alignment Between Documents: Ensuring consistency between the two documents was crucial but difficult to achieve while working to tight PSUR reporting deadlines.
The Solution
We took a strategic, collaborative approach to address these challenges:
- Dual-Writer Assignment: Two experienced Certara safety/aggregate report writers were assigned to the project. Each writer took the lead on one PSUR while supporting the other, ensuring alignment and consistency across both documents.
- Subject Matter Expertise: One writer had prior experience with the drug product and the client team, allowing for seamless integration into the project.
- Staggered Timelines: The timelines were adjusted so that the 1-year PSUR was completed and reviewed before the 2-year PSUR. This staggered approach allowed for sequential team reviews and eased workload bottlenecks.
- Quality Control (QC) Efficiencies: Feedback and QC comments from the 1-year PSUR were incorporated into the 2-year PSUR. Sections that overlapped between the two documents were reviewed during the 1-year PSUR process, eliminating the need for repeated QC efforts.
- Time Zone Advantage: The writers were based in the UK and the US, allowing the team to maximize productivity by leveraging time zone differences for continuous progress.
Impact
Our flexible approach delivered several key benefits to the client:
- Anticipation of Regulatory Needs: By identifying the requirement for an additional 2-year PSUR, we enabled the client to meet regional regulatory expectations that were not initially anticipated.
- Timely Submission: Both PSURs were aligned and submitted to their respective regions on schedule, ensuring regulatory compliance.
- Operational Efficiency: By reusing QCed content from the 1-year PSUR in the 2-year PSUR, we were able to save the client time and streamline the review process.
Periodic Safety Update Reports (PSURs) vary in requirements based on the type of product and regional regulations. Drawing on their extensive experience, Certara’s experts anticipate regulatory needs, adapt to evolving project demands, and deliver expert support to ensure compliance and regulatory success.
Explore insights on harmonizing pharmacovigilance documents, such as DSURs, RMPs, and PSURs, in our detailed whitepaper.
