Embedding regulatory intelligence for improved change-control processes: part II

How companies can increase efficiency, save costs and make better decisions with integrated information

Once a company decides to move forward with a change, each group moves into execution mode. For regulatory, that means filing variations to comply with country requirements. In this area, there are two types of uncertainty that need to be addressed: understanding what each agency will require and knowing if the submission documents and the information they contain are current. These challenges often lead to delays.

Removing uncertainty during submission processes: When regulatory knowledge is integrated into processes and systems, global variation filings can be accomplished much more quickly. “Companies would love to have better upfront information. Imagine if you could say, I want to submit to Bolivia, and real-time intelligence immediately showed that there are 10 documents that Bolivia will absolutely want for this type of change,” said Bernie Coney, Head of Regulatory Advisory Services at Kinapse, a life sciences consulting firm. “You could assemble the required materials much more efficiently.”

Dossier-level intelligence within a RIM system could embed that regulatory knowledge in submission templates. Companies have struggled with this challenge for years, relying on overly complicated Excel spreadsheets. Using predefined business rules to dynamically create a table of contents would significantly aid planning, co-ordination between regions and the review process for submissions and their components.

There are many different types of ancillary documents, and requirements vary by country. Although this content is relatively standardised for major markets, headquarters may not know what is required by other countries until the local submission is initiated. This can immediately put the process behind schedule. Ideally, submission content plans generated by the RIM system would reveal the ancillary documents required for submissions around the world, streamlining what is often a complicated and reactive process.

Applying supply-chain thinking to the orchestration of ancillary documents: The automotive industry uses a supply chain approach to orchestrate the on-time delivery of required components. Harry Smyser, an independent consultant at Kinapse with 25 years of experience in supply chain and regulatory functions, believes life sciences companies can apply similar methodologies to assembling variation filings.

Regulatory can manage ancillary documents holistically, with dependencies and idiosyncrasies factored into the process from the onset. “If I’m making an equipment change for a product that is manufactured in France but sold in Mexico, the Mexican agency will need a certified pharmaceutical product (CPP) from France attesting to the fact that the manufacturing site has passed inspection,” said Smyser. “Getting a CPP from France can take 6 months. That process should be initiated as soon as the change is green-lighted by the review board, instead of waiting until the core submission documents are ready.”

Ensuring current and accurate documents: When assembling submissions, it is difficult for regulatory to know whether the content within the documents is still accurate. Text, graphs and charts are manually copied and pasted so many times that there’s no easy way to verify that the data is current. And, as affiliates may assemble their submissions a month or more after the original filing, they must reconfirm whether updates have been made in the interim.

In many Latin American countries, the bundling and unbundling of change requests makes it even harder to know what’s current. Not only do bundled variations introduce delay, but the bundled submission differs from the individual component submissions. The delays caused while affiliates validate information or update outdated charts can have a dramatic impact on timing and revenue.

When document information is turned into structured content or data, it can be managed with more precision. Having an authoritative source with granular control ensures accurate and up-to-date information is maintained across multiple submissions, significantly reducing cycle times and eliminating the need to rerun reports or search for updates. “This reflects the complete spectrum of dossier-level intelligence,” said Coney. “For each country, regulatory knows what documents are needed, knows where to find them and knows whether the content is current.”

Managing inventory and product-supply release

The poor visibility of regulatory information can have big repercussions on product release. Companies must balance the timing of product releases, production changeovers and inventory levels across impacted markets. A lack of co-ordination between regulatory, quality, manufacturing and supply chain teams can lead to higher production costs, product shortages and compliance issues.

Optimising inventory management and timing of changes to the production line: Companies can only release updated products to market after they have been approved by the relevant health authority. Firms work hard to prevent mistakes and avoid delivering updated products before they are approved; but, this gets complicated by the number of variations submitted each year.

The length of time it takes to secure regulatory approvals across each market can have an impact all the way down to the production line. Accurate demand forecasting is essential to optimise production and minimise the time spent running dual production lines while waiting for approvals to take place.

Improving the timing of supply release according to what is approved: To effectively manage supply release, approvals must be tracked globally and reflected in product registration details. That information needs to be readily available to quality teams and, specifically, Qualified Persons (QPs). This requires affiliates to track the status of variation filings in a shared system, so that the global view into approvals stays current.

Grouping a variation submission and its associated communications by health authority helps regulatory to keep track of what has actually been approved. Companies also need systematic approaches to the sharing of approved data with quality teams. Processes that are dependent on emails and phone calls are impossible to scale and introduce the risk of human error. Sharing registration details via reports or direct access can save a great deal of time and back-and-forth between groups.

Global biopharmaceutical company UCB recently implemented a data transformation programme that aligned regulatory information for a smarter supply-release process. To make information transparent to the right audiences, UCB began issuing automated reports showing the current state of approvals. This replaced ad hoc email exchanges with a reliable, weekly flow of information. QPs releasing products to market now have current and accurate data, ensuring that the product they are releasing exactly matches the information on file.

Moving forward, UCB would like to deploy a dashboard or other real-time approach. One method is to grant quality individuals or the QPs direct access to the RIM system, from which the individual can view dashboards with the status of regulatory approvals or reports with relevant product registration details. Security controls can be configured so that only appropriate data is shared, preventing any misunderstandings related to confidential information.

The best strategy is to standardise regulatory and quality applications on a common platform, allowing relevant regulatory information to be accessed via the quality system. This approach simplifies processes and eliminates challenges with maintaining integrations and a validated environment during system upgrades. Quality teams and QPs depend on information from departments beyond regulatory to fully implement changes. Moving towards a harmonised and consolidated dashboard that pulls data from related departmental systems — ERP, labelling and others — is a more effective strategy for keeping quality and the CCRB updated.

Positive outcomes with regulatory intelligence

By bringing regulatory and quality teams closer together, with regulatory information accessible throughout the change-control process, companies can transform change management from a burden into a competitive advantage. For UCB, one of the most impactful initiatives was the implementation of a master data management programme that standardised a select few data fields that were frequently duplicated between systems.

Gordon Topping, Senior Director, Submission Portfolio and Regulatory Knowledge Management at UCB, found that connecting information across key functions delivered significant business value. “Master data management is the most transformative piece for us,” he said. “Simply being able to link manufacturing stock-keeping units with registered package details has been a sea change in how we approach things.”

Companies can dramatically improve efficiencies and speed variation filings with integrated information and processes. Whether submitting variation proposals or making product ship decisions, teams can trust that the data is correct. For large organisations, these benefits translate into millions of dollars each year and more than justify the effort in leveraging regulatory intelligence to improve the change-control process.

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