Automation efficiency and risk mitigation in regulatory report writing - Ennov / DIA RSDIM 2020
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I want to share with you how it is possible to automate regulatory report preparation – by sharing my experience, where we took a 5-8 hour complex, manual process and transformed it to a simple 2 minute activity. I’d like to start by providing a brief background on the manual process followed by a description of how automation of this process was accomplished and how it can be applied in your organization. Hopefully you’ll leave here today with some ideas for how to move the needle towards saving time on report preparation, allowing you and your team to spend your valuable time on other important activities. Regulatory report generation can be one of those redundant and manual activities that are very important from a regulatory perspective but are a real time-sucker. Usually there are multiple individuals or departments involved in the report preparation. And, there might not be 100% alignment among teams. Add affiliates and outsourcing partners to the equation and what seems like a straightforward process can get complicated quickly.
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Automation efficiency and risk mitigation in regulatory report writing - Ennov / DIA RSDIM 2020
- 1. Regulatory Submissions, Information, and Document Management Forum February 10-12 | North Bethesda, MD Dr. Kristen Mandello, Ennov Automation, Efficiency and Risk Mitigation in Regulatory Report Writing
- 2. © 2019 DIA, Inc. All rights reserved. Disclaimer Page 2 The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to DIA, its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. DIA and the DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
- 3. 11 February 2020 | Bethesda, MD Dr. Kristen Mandello, Ennov Automation, Efficiency and Risk Mitigation in Regulatory Report Writing
- 4. Agenda Page 4 A story of manual regulatory report preparation Why we all need a little automation in our lives What do organizations need to consider when automating regulatory report preparation? How does regulatory report preparation bring operational efficiency and strategic risk mitigation?
- 5. Manually Prepared Regulatory Reports Page 5 Multinational animal health company 3k products and 7k brands registrations globally 35k+ adverse events worldwide annually More than 200 standard regulatory reports • Regulatory - Required by National Competent Authorities (NCAs) • Business - Required by Safety and Data Exchange Agreements (SDEAs) Numerous, dynamic “regular but not standard” reports Limited workforce Tight timelines Large, complex data sets
- 6. Maybe Your Story Is Different… • Small, national company • Few registered products • Reporting requirements other than PV • Ad hoc reports • Small, manageable data Limited workforce Tight timelines Large, complex data sets Page 6
- 7. Manual Report Preparation process Page 7 RIM Data / Information Report Template Draft Report Final Report Data / Information Data / Information Regulatory Report Timeline Report Preparation Analysis / Evaluation Report QC Review and Approval
- 8. Why we all need a little automation in our lives… Page 8 We Value People Our Patients Our Stakeholders Our Teams
- 9. How: 5 Steps to Automatically Prepare Regulatory Reports #1 Identify Reports • Regulatory reports • Internal reports • Ad hoc reports with standard format #2 Identify Data • Adverse event data • Distribution data • Previous report data • Others #3 Create Template • Include standard text and create links for data to be inserted based on the user generated form #4 User selection interface • The items in the form are completed by the user • Key data points can be auto-loaded into the report template #5 Link & automate • Adverse event data • PV signal data • Previous report data • Distribution data • Others Most companies struggle with siloed or disconnected information. You may know what data you need but you may need to do a bit of pre-work to have it available for the automated process. I’ll walk us through the challenges we faced in this area on the next slide …
- 10. Data Warehouse Doses Distribution DB Regulatory RIM PV DB Marketing Product Management DB product attributes mapping from RIM to Marketing Product DB User interface that automatically integrates doses sold and Pharmacovigilance data for use in calculating reporting rates and performing analysis for products for any given time period, country, batch, etc…
- 11. Generate Automated Reports PERIODIC SUMMARY UPDATE REPORT 1. Enter 3 report parameters (product, date range, dose adjustment factor) 2. Click the “Generate report” button 3. Voilà! A report is generated in word processor format, with the appropriate data embedded in tables and within the text The system also executes programmed calculations, with the results embedded in the document Time needed to generate the report: About 2 minutes Estimated time savings 5-8 hours per report! Functionality to be extended to other PV reporting needs 11 |
- 12. Template example: VICH GL 29 Periodic Safety Update Report 12 | Text Generated Based on Underlying Data Data Presented in Tables Data Embedded Within Text
- 13. How it Can Be Done Differently Page 13 RIM Data / InformationReport Template Draft Report Final Report Data / Information Data / Information Regulatory Report Timeline Report Preparation Analysis / Evaluation Report QC Review and Approval
- 14. > ROI: freeing up resources to perform data analysis to improve product safety and perform value-added activities to turn PV data into business intelligence Automated Reporting is Win - Win • Reports and report set up based on standard procedures – quality documents lead to quality documents • Validate auto-report generation and reduce your report QC requirements • Instantly see data output for reports – quickly identify any data inconsistencies or errors. • Easy to address any data issues and re- run reports in minutes! • Create standardized reports once and run them on-demand • Generate reports in a fraction of the time • Be in the position to support regulatory activities (i.e. geo-extensions of product approvals, responses to health authority questions, etc.) • Add time to your regulatory report timelines – with only minutes to create the report, you have days to more deeply evaluate the data contained in them • Become the source of business intelligence within your company • You are in the driver seat – in addition to regulatory reporting requirements – now you can create the reports and presentation you have always wanted but didn’t have the time for…. EFFICIENCY QUALITY
- 15. Critically evaluate your current processes – automation is a game changer Requires collaboration between functions Minimal, short-term cost/effort to realize significant and lasting efficiencies Mitigates risk by having a validated, automated system based on a quality process Brings Operational excellence Empowering your team Makes room for higher quality end-product Expanding function’s capabilities Adding value to patient safety and the business Final Thoughts Page 15
Editor's Notes
- Good afternoon, and thank you for attending this session. I would also like to thank the Program Committee for inviting me to speak with you today. I am Dr. Kristen Mandello and I work at Ennov, where I am responsible for helping companies create innovative solutions to regulatory challenges.
- Today, I want to talk with you about one area that when addressed, can be transformational to an organization: too much time spent on repetitive manual activities. I want to share with you how it is possible to automate regulatory report preparation – by sharing my experience, where we took a 5-8 hour complex, manual process and transformed it to a simple 2 minute activity. I’d like to start by providing a brief background on the manual process followed by a description of how automation of this process was accomplished and how it can be applied in your organization. Hopefully you’ll leave here today with some ideas for how to move the needle towards saving time on report preparation, allowing you and your team to spend your valuable time on other important activities.
- My background is in PV and animal health, so the examples presented today will have that flavor. But I think you will see that the concepts apply to a variety of regulatory reporting scenarios. In my previous role, as the Global Head of Pharmacovigilance for Sanofi’s multi-national Animal Health Division, Merial we managed a large volume of registered products globally, and as a result were tasked with writing a large volume of aggregate reports. To be clear I am not referring to individual case reports, rather reports required by regulation or regulatory commitment to obtain or maintain the registration of products. The majority of these reports had set requirements for what must be included in the report, but not all had a specific report format. Within our organization we developed templates for each report type which was used as the starting point of the manual process. We faced three key challenges …
- Maybe your situation is different but I am willing to bet you face the same three challenges and would like to focus your time on more strategic work. By a show of hands, how many of you are in organizations who have a manual report preparation process?
- Regulatory report generation can be one of those redundant and manual activities that are very important from a regulatory perspective but are a real time-sucker. Usually there are multiple individuals or departments involved in the report preparation. And, there might not be 100% alignment among teams. Add affiliates and outsourcing partners to the equation and what seems like a straightforward process can get complicated quickly. (Describe left side) For us, the majority of the regulatory report timeline was taken up with report preparation, (click) and there was little time for data analysis and medical evaluation – certainly no time collaborate or conduct more in depth investigation. We were mainly focused on compliance (click) and getting the reports to final QC, submitted and translated if need on time, and archived in our RIM system. From a management perspective, having key institutional knowledge with just a few key people puts your organization at risk if they are suddenly unavailable. So we knew we needed to do something to improve the situation…
- To take a page out of Steven Covey’s book - We started with the end in mind And thought about why we are doing this in the first place?? (BUILD SLIDE) At the heart of it all - we value People We value our patients and seek to be good stewards of the medical products we produce or manage We value our stakeholders, and understand that efficient business practices are necessary to make certain we are using our resources appropriately We value our teams – and see to empower them, ensuring they are focused on high value activities
- #1 It is important to identify a report for which you already have a stable template and process for preparing – we selected the VICH GL 29 PSUR #2 Most companies struggle with siloed or disconnected information. You may know what data you need but you may need to do a bit of pre-work to have it available for the automated process. I’ll walk us through the challenges we faced in this area on the next slide #3 create the logic within the Word document template to enable automation. How may here are the person responsible for putting the regulatory reports together? This is your part! Here is where you codify the process you apply to the template. For example in the reports we prepared, we would need to query the PV database and use pivot tables to create subsets totals by country, time period, seriousness, etc. as a ratio of the number of doses distributed and insert these throughout the template. So we created macros throughout the Word document for each data point in the report. #4 Then you identify the parameters specific to the report – for each run of the PSUR we needed to define the previous and current report time periods, product and any dose calculation per species. But, before we could complete step #2 we had some work to do.
- Together with IT and Business colleagues, Pharmacovigilance created a direct mapping between the registered product name and the appropriate product identifier in the commercial product DB , to enable time period driven, global, product specific doses sold data for use in PV This was necessary for automating our aggregate report preparation process, but we also realized a collateral benefit of improved analysis function.
- So for us, at the end of a year and a half of work, we had an automated VICH GL 29 PSUR to use for regulatory reporting, geo-extension for preapproval regulatory submission, and internal use We had a user interface to enter our 3 report parameters and in less than 2 minutes we had our draft report – ready for QC and medical review We ended up saving enough time to represent one FTE, allowing team members to shift their time from number crunching and report preparation to supporting signal detection and a variety of other value added activities.
- As you can see here – the Word document template has embedded within tables, data in numeric and text, organized and ordered as needed.
- And this shows how the new automated process worked: Information in our RIM would kick off the process, Instantly the draft report was created and the data could be checked. If there was a problem, it could be addressed and the report re-run in minutes. In the past, data problems meant the loss of valuable days in our timeline. More of our time was dedicated to data evaluation, investigating the origin and cause of any interesting signals or trends We also improved our metrics for on-time report preparation. We now had the time to proactively address issues in the report before the regulatory authority could raise them. We now had a validated, computerized system to prepare our regulatory reports while mitigating risk Risk of human error in report preparation Reduced QC requirements Proactively identifying signals and trends for early alerts or defense of our products.
- Overall the entire process was a huge win for us as a team and a company. We shifted our focus from administrative tasks to doing the real work of Pharmacovigilance -monitoring product performance in the field and being good stewards of our products. We won on the efficiency front: With easy to generate reports in a fraction of the time, giving our medical reviewers more to analyze the data and write more robust summaries. In addition to having an impact within Regulatory, overtime we became the source of valued business intelligence, and empowered our talented team to do more in the area of compliance and surveillance. From a quality standpoint, our automated process followed our quality procedure, and with the draft report generated in a validated computerized system, our QC effort was reduced and we could quickly and easily address any quality issues identified. We really felt the impact of what we had accomplished when we were asked by our RA team in LATAM … (BR story)
- What’s the take away? This was something we were told was not possible, would take to long would be too expensive and would not have a good ROI. I’m glad we did not believe that, because this was a game changer for us, and opened the door to cross functional collaboration that did not previously exist, lasting efficiencies and time and resources to be directed to more high value activities. This process empowered our team members to do more, our reports to say more, our function to contribute more, and at the end of the day we added value to patient safety as well as to the business.
- That brings me to the end of my presentation. Thank you for your attention. I’d be glad to answer any questions you might have