A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

[Editor's Note: Part 1 of this article discussed the definition and framework of regulatory intelligence. However, what was not discussed are the different tools available to aid in quality/regulatory professionals and the future of regulatory intelligence.]

Different Tools Available for Regulatory Intelligence

In the dynamic regulatory landscape of biopharmaceuticals, regulatory intelligence professionals need to have many tools within arm’s reach. It is vital that these tools remain agile and fit for use in each of the functions of the regulatory intelligence life cycle.

To better organize this data, we will break it down into five distinct categories and present the tools and attributes. Keep in mind that this is not an exhaustive list.

1. Tools for Monitoring for regulatory information
2. Tools for Capturing and Distributing information
3. Attributes for Business/Risk Assessments
4. Attributes for Tracking Assessments
5. Tools for Reporting and Metrics

Tools for Monitoring for Regulatory Information

In the role of regulatory intelligence, we need to keep track of tens of thousands of sources. There are hundreds of different authorities and their websites (and their subparts, divisions, centers, etc.), hundreds of news organizations, and databases that are filled with a plethora of documents to keep track of. There are four major areas that we have organized here to better structure this information:

1. Regulatory Agencies
2. Website Monitoring Tools
3. News Organization
4. Subscription-Based Services

Regulatory Agencies

There are many authorities that regulatory professionals need to monitor to maintain compliance. In the lowest form of maturity, a regulatory professional could manually go into each regulatory agency’s website and monitor for change. However, this would be inefficient. Therefore, the regulatory professional can subscribe to a regulatory agency’s subscription newsletter via email. Then, the regulatory professional can monitor for change by reviewing these emails. Remember that there may be multiple subscriptions for each agency’s website.

Another way to keep track of changes directly from the regulatory agency’s websites is by utilizing their Really Simple Syndication feeds (RSS). An RSS feed is a web feed that allows users and applications to access updates to websites in a standardized, computer-readable format, typically via their email interface. Agencies that have RSS feeds include the U.S. FDA, the European Medicines Agency, the Pharmaceuticals and Medical Devices Agency, Health Canada, and Swissmedic.

Website Monitoring Tools

There are many other websites that do not have automated alerts sent from the agency to the user. To bridge this gap, include monitoring tools. These commercialized tools keep track of specific websites and their changes as specified by the user. Users can configure the tool to monitor for any changes and immediately alert the user. The tools typically have photograph snapshots (e.g., PDF, JPEG, etc.) highlighting the website's changes. Therefore, a regulatory professional can keep track of any changes made to a particular webpage.

Some examples of these website monitoring tools are:

• Website Watcher
• Change Tower
• VisualPing

News Organizations

Another popular area for regulatory professionals to stay apprised of the changing regulations is newsletters. While we are familiar with major news organizations such as the Associated Press, the Wall Street Journal, and the British Broadcasting Corporation, there are industry-specific news organizations available. Some subscriptions require a fee.

Here is a list of a few major ones:

• Fierce Pharma
• Fierce Biotech
• STAT News
• ECA GxP Newsletter
• FDA Law Blog
• IPQ Newsletter
• Citeline (previously known as Informa)
• Pink Sheet
• Scripp
• MedTech Insight
• Health, Beauty, and Wellness Insight
• Generics Bulletin
• The Pharma Letter
• PDA Letter
• ISPE Pharmaceutical Engineering
• RAPS Rapporteur

Subscription Based Tools

While many tools are available for a professional to use, it requires the user to manually maintain these lists and confirm that the website’s links are still active. To alleviate these pangs, there are subscription-based tools that regulatory professionals can use to ask companies to do the heavy lifting. These subscription-based tools are typically organized in an accessible and archival structure to allow users to retrieve information efficiently. Some of these tools also integrate how professionals can capture the information and perform assessments within the tools, which will be explained in the next section. However, access to different subscription-based tools does not directly translate to a mature program. The ability to effectively monitor, collect, and utilize the information would indicate a more mature program.

Here is a list of a few major ones:

• Clarivate Cortellis/ClaRITA
• IQVIA/Tarius
• Redica Systems
• The ABIS Group
• FDA WebView
• Thomson Reuter’s Regulatory Intelligence
• Freyr Solutions
• Greenlight Guru

Tools for Capturing and Distributing Information

 Storage

Once information is gathered, storage is critical as a means for knowledge management and distribution. The following are different ways to store information:

• Emails where the bookmarks are stored internally on an individual’s computer that is not centrally shared.
• A Microsoft Excel spreadsheet that may be shared.
• A cloud-based platform, such as SharePoint online, MS Teams, Dropbox, or Google Drive.
• Off the shelf platforms with processes embedded in the tool such as Jira or Smartsheet.
• A tailor-made platform that is enterprise specific.

Distributing Information: Evaluation, Triage, and Assessment

While monitoring for the changes in regulatory requirements is important, communicating and disseminating the information appropriately to the organization is critical. Here, we have some typical tools to help capture and distribute information. Some tools may already be available at your organization, while others may need more integration.

• Emails sent directly to individuals or Excel/Spreadsheets that live locally on a computer.
• Emails sent to a distribution email address where personnel are added to the appropriate distribution list or Excel spreadsheets that live on a cloud-based server that certain individuals are allowed to join/subscribe.
• A PDF newsletter that is shared on a periodic frequency, typically via email.
• A cloud-based tool (e.g., SharePoint) that has some built in automation to distribute information and can keep track of Subject Matter Experts (SMEs) assessments.
• A subscription-based or customized tool that can help capture and project manage the information to be distributed to stakeholders and keep track of SME’s assessments. Some examples are Smartsheet, Jira, Cortellis’ ClaRITA, and Redica System’s Collaboration tools.

Attributes for Business and Risk Assessments

After capturing the relevant information, there should be a systemic approach towards reviewing the information and assessing the impact on business. As a best practice, it is recommended that a small group of individuals have the following attributes.

Attributes needed for this group consist of the following:

• Ability to review information and assess whether it has impact to the business, such as therapeutic area, modalities, or marketed regions.
• Ability to connect information to relevant SMEs for an accurate assessment.
• Ability to prioritize the information in a risk-based approach.

Attributes for Tracking Assessments

Many of the tools mentioned in the “Tools for Capturing & Distributing Information” can also be further enhanced to help track an SME’s assessment status (e.g., pending, in review, completed, etc.). The more attributes you can track reflects an increasing maturity program. The main attributes of the tools used to track assessments are:

• Ability to keep track of the amount of information the business has received.
• Ability to keep track of the amount of information the business has reviewed and its impact on business.
• Ability to keep track of the amount of information the business has distributed to specific SME or departmental functions.
• Ability to keep track of the SME’s assessment statuses:
• • Pending
  • Implementing Changes
  • Change Control/Deviation
  • This being a GMP activity, it needs to be performed in a validated quality system and referenced in this tracker.
  • Completed
• Ability to aggregate these metrics into a centralized manner to be reported (e.g., dashboard).

Tools for Reporting and Metrics

The previous attributes can be centralized with different tools for reporting. This reporting is typically presented in management review (e.g., Quality Management Review) on a periodic basis.

Here is a list of a few major tools:

• Tableau
• Microsoft Power BI
• TIBCO Spotfire
• SAP Business Object BI Suite
• GoodData
• Google Analytics
• Smartsheet Dashboard

Another approach is to evaluate reporting capabilities within existing tracking tools. In general, the more an organization or program can effectively track different metrics, the more mature the program is.

Conclusion: The Future of Regulatory Intelligence

In the past, regulatory intelligence was monitoring changes in a paper-based format. In this digitized era, we are now accustomed to reviewing changes on a computer and tracking these changes in a computerized system. We are now at the point of highly automating the monitoring and distribution of regulatory information. However, we must brace ourselves for the next revolution, artificial intelligence (AI).

As AI is a new tool, we must evaluate how it can help with regulatory intelligence. AI presents the opportunity to gain efficiency in how we monitor information, capture the information, and track the assessments. The speed of integrating AI in the pharmaceutical industry is quickly accelerating. Therefore, it is important for regulatory intelligence professionals to look ahead and consider the impacts, both positive and negative.

AI's wider reach and faster processing of regulatory information will allow the professional to focus on high-value work. It will enable the professional to make informed decisions promptly and take action to ensure compliance. However, it is the author's experience to use the AI tool cautiously. We have experienced situations where incorrect information and reference sometimes fictitiously generate guidances. As AI is still in its infancy stage, we hope the industry will use a risk-based approach in integrating AI for regulatory intelligence.