September 8, 2016
By Mike Hagan and Ronan Donelan, BioSpace.com Contributors
It wasn’t that long ago that every piece of information the healthcare industry captured, from patient records to marketing authorization renewal submissions, were recorded on paper. It was the way it was always done, but it was inefficient, prone to errors, and created unnecessary work and additional burdens to maintain accurate records.
Fortunately, for the most part, our industry is embracing the move to a paperless environment thanks to the proliferation of electronic health records, patient registries, quality risk management systems, and other software-based solutions that add speed and efficiency to the data gathering process.
Though one area where pharma has been slower to make this transformation is around regulatory affairs and especially for marketed product maintenance.
Large-scale tracking of submissions and approvals within the pharmaceutical industry is still mainly spreadsheet-based, which prevents transparency and creates a lot of additional work and room for error. As a result, these processes require significant time and overhead costs, and many companies still struggle to monitor the regulatory status or garner basic insights into their portfolio of marketed products. There are obstacles in gathering information such as which products are registered in which specific markets and the exact contents of submissions, especially if they lack English translation of the submissions and approved labelling.
But several industry trends are finally pulling marketed product maintenance into the 21st century. Regulatory demands for electronic filings and updates, and impending standards for the identification of medicinal products (IDMP), coupled with increasing pressure to take advantage of the time, cost and compliance benefits of electronic data management tools, has driven many industry players to finally invest in electronic regulatory management systems.
Many of the companies that have made the transformation from spreadsheets to an effective electronic management solution are experiencing a cascade of benefits to their product maintenance process. For example:
• Electronic solutions make data easier to monitor, review, assess and approve, eliminating the need for multiple review steps that can add days to the process. That helps simplify regulatory data management on a regional and global scale.
• Helps companies promote better quality in regulatory applications, documents and maintenance, and allows for easier updates of registered details in all markets.
• Provides greater flexibility for lifecycle planning, execution and reporting using dashboards to improve understanding of status.
• Links regulatory service deliverables with commercial systems to allow near real-time understanding of the regulatory, commercial and net present value of an asset at any time in a country or region.
• Facilitates decision-making on trending investments required for maintenance and allows for more informed decision-making on divestments and acquisitions.
All of these benefits cut time and cost from managing marketed products while increasing confidence in the compliance of registered details, and facilitating faster, more focused remediation measures when needed.
But the technology solutions on their own can’t deliver all of these benefits. It only works when companies are willing to reform their product maintenance processes to take advantage of the new technologies.
One of the key components of manual, paper-driven maintenance work is that every piece of data needs to be meticulously tracked and reviewed, often by multiple parties, before documents are completed and submitted. It was a necessary step when data was manually translated in order to mitigate the risk of errors, but with the right technology and processes in place, such extra oversight is unnecessary and can be overly burdensome.
To streamline this process, Quintiles is implementing business process automation that goes beyond workflow automation in that the system delivers pertinent information needed to complete the assignment when the workflow is triggered. We have linked knowledge management, regulatory intelligence and task specific metadata to assist the employee in completing their assignments with all the information in a single workflow.
Unlike a manual system, today’s technologies support information integrity and reliability by funneling data through centrally-held portals and building structured content that allows for greater interoperability across different global systems. This eliminates the need for much of the micro-management that was such an integral part of the paper-based approach.
For example, if a company needs to make an update to a product’s prescribing information, the label update and marketing materials in every market can be easily managed by employing software systems. These systems are designed to instantly search for and pull up every relevant document and make the necessary change with the stroke of a key—versus spending hundreds of man-hours reviewing every document line-by-line to scan for the necessary data or inconsistencies. That saves enormous time, and can reduce the risk of potential errors because changes can be made far more quickly and with greater assurances that nothing has been missed. But these savings are only accrued if the user trusts the technology to do its job.
Regulators are rapidly adopting requirements that pharma companies submit product information using electronic media, which means pharma companies have no time to waste to ensure they can comply with these new agency requirements. They need to embrace these tools to meet new submission criteria. By choosing the best technology providers, and working with their partners to adopt the necessary process changes, pharma companies can meet regulator demands, significantly cut the time and cost of product maintenance, make better informed decisions and begin to de-risk their entire data management process.
Michael Hagan is Senior Director, Regulatory Affairs at Quintiles and Ronan Donelan is Senior Director, Regulatory Affairs and Head of Global Regulatory Affairs Europe at Quintiles.
