By Tracy Rockney


Pharma veteran Tracy Rockney, the co-founder and managing partner at expert advice service OneSource Regulatory, gives her tips on using technological tools to navigate regulatory compliance in an Expert View piece.

Compliance with regulations is a complex endeavor in any highly-regulated industry, and the pharmaceutical industry is no exception.  We only need to look at investigations involving regulatory violations to recognize the continuing demand for qualified regulatory professionals.

With the right technology and strong leadership, regulatory affairs professionals can transform their roles to become strategic partners for their organizations, facilitating solutions to grow business in concert with their commercial counterparts.

Along with co-founder Robert Merrill, we have used our 20-plus years of experience to create the first free, one-stop platform for accessing regulatory and compliance information to better drive strategic value – MyIndago™.   I want to encourage others to embrace technology by sharing the four key success factors underlying innovation within this space.

1.  Solve small regulatory concerns to gain strategic value

Regulatory Affairs professionals share similar concerns – where should they query health authority enforcement communications such as US Food and Drug Administration (FDA) inspection letters, warning letters, enforcements, and other regulatory documents?  These documents typically pose a huge problem in terms of where they can be located, how they can be synthesized to detect patterns, and how they can be assessed with little or no cost when many regulatory departments have little to no discretionary budget.

The problem with accessing regulatory documents may be considered a small issue by some leaders, but it was this small issue that inspired MyIndago.  Dealing with seemingly minor problems can lead to beneficial business drivers and cost-savings.  Innovation is not limited to the big questions in pharma business; it also has a place in tackling small (but critical) issues.

This is also illustrated in the way so many pharma personnel analyze enforcements by focusing on what regulators say about what they can’t do.

What about those areas that were preserved and not commented on?  What isn’t said is just as important as what is, and can in fact provide insights for alternative messaging and strategic value.

2.  Work with individuals to reduce fear of technology and add value to their jobs

Within the scope of the five stages of technology adoption, the regulatory affairs area can be categorized as a “late majority” – individuals who adopt an innovation after the average member of society.  These individuals approach disruptive innovations with a high degree of skepticism and may fear the impact of the change on their role within the company.

For technology to be adopted within a company, it must enhance the professional’s work, not create fear.  In my past role as a VP leader of a large regulatory function, staff were reluctant to adopt change if they saw it as a threat to their role.  When technology reduces routine administrative tasks, employees understandably question where this saved time will be spent.

The key is to redeploy this time into more strategic tasks that align employees with new opportunities within the company, enhancing their skillset and adding value to their futures.  With technology, tasks that have taken two-three weeks now take hours, allowing employees to leverage their analytical skills and position themselves strongly within the company.

A great example is the DOC Label solution, which is used by many larger companies and allows them to identify labeling insights in minutes.  Provided by OneSource Regulatory in partnership with Doctor Evidence, the DOC Label solution is a centralized web-based repository for data contained in medication package inserts that allows users to directly compare and contrast labeling information across over 100,000 prescription human drug labels, including current and archived US Package Insets and UK Summaries of Product Characteristics.

Leaders must provide a clear vision of a future role: less time spent on non-strategic work because of technology adoption creates greater opportunity to become involved in strategic research and development and marketing endeavors.  Inspire your employees to embrace new technology solutions and new ways of working.

3.  Find solutions in the right technology

Technology today should not require extensive training – if it is difficult to use, not relevant to the required work, or perceived as a nuisance, it will not be adopted.  Regulatory affairs professionals will be better able to understand regulatory landscapes across various countries, monitor and interpret regulatory changes, make timely compliance-related decisions and actions, and maximize regulator engagement when they have solutions that meet their everyday needs.

To be accepted and embedded into the organization, we first need to establish a common understanding of what constitutes “high-value” tech.  In my experience, four components are needed:

  1. Ease of use
  2. A solution-based approach
  3. Affordability
  4. 100% adoption and integration with workflow

Some companies may be quick to assume that complex-sounding technological tools are easy solutions to drive regulatory outcomes.  However, it is not the cost and complexity of the tool that matters.  More importantly, regulatory leaders need to set a solution-based vision for the department: that with technology comes efficiency and improved strategy.

4.  Leadership with a solution- and value-based vision

Even the “right” technology will faith without a strong leader who can articulate a vision of its value.  Successful adoption of new technology relies on active leadership.  For instance, I found it very effective to embed implementation standards into my staff’s performance goals, establishing the expectation for my team to use specific technology and make them accountable for adapting to change.  Requirements to use the technology were supported by opportunities for new project assignments and exposure in our organization.  Leaders must instill a mindset and work ethic that embraces the technology they stand by.

I also provide evidence of tangible benefits to adopting this new technology via financial investment analysis and the illustration of ROI.  I expressed my belief in the staying power of this new way of working, which acted to embed change quicker, ease staff anxieties, and ultimately transform regulators into strategic partners with the research and commercial sectors of our organization.

We can change the status quo in regulatory strategy and compliance by using the right technologies and adopting a more relevant perspective on the true purpose of technology for the regulatory professional.  To move from mere enforcement of regulations to the use of compliance as a strategy for business goals, we need to view high-value technology-based solutions, such as MyIndago, as the modern solution – a solution that, if driven by leaders with a vision for the technology and how it can make employees’ jobs more efficient, can add strategic value to regulatory affairs professionals and the company.

Embracing Technology to Transform Regulatory Professionals into Strategic Partners 

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