This article describes one global pharmaceutical company’s efforts to improve efficiencies, maintain compliance with new standards and gain greater internal alignment. By reorganizing its regulatory operations function, centralizing regulatory processes and implementing cloud-based technology to modernize regulatory information management, the authors describe the journey toward productive change.
Introduction: Making the Business Case for Change
Because the cost to bring therapies to market is ever increasing and demand for better, more targeted drugs and vaccines continues to grow, companies are constantly searching for ways to expand the development pipeline and get products to patients faster. New technology has become a major driver in this effort.
For example, in April 2017, the company’s leadership identified new long-term priorities with areas to be addressed, including innovation, performance, trust and streamlining regulatory operations.
Leadership knew the company could better manage challenges facing the industry by improving regulatory operations and, accordingly, focused on three core areas: people, processes and technology. The following were guiding principles that have continued to drive and inform decision-making in this transformation
- simplification/internal alignment
To create additional efficiencies, a comprehensive review of all processes and systems, roles and responsibilities and geographic locations became the first step. The second step was to improve compliance and ensure quality, making certain processes and delivery mechanisms would be robust and in-line with the forthcoming Identification of Medicinal Products (IDMP) standards
. Third, better internal alignment between two divisions—pharmaceuticals and vaccines—and between central functions and affiliates were needed to reduce process redundancies and increase speed across global regulatory operations.
Understanding People, Roles and Responsibilities
In July 2014, the company took a closer look at regulatory workforce job descriptions, functions and workloads to ensure employees were able to do their jobs as effectively and efficiently as possible and have opportunities for advancement. This required conducting an “above the line, below the line” exercise, using an industry standard workplace tool designed to help team members discover ownership, accountability and responsibility while identifying areas for improvement. At the time, regulatory duties were spread across various divisions and departments and, in many cases, a spirit of “everyone does everything” pervaded. Some people were “spread thin,” others had overlapping work areas, many had manual and repetitive tasks that created inefficiencies and lowered morale.
Based on the feedback from interviews and the review exercise, steps were taken to rewrite job descriptions for more narrowly defined work and develop clearer expectations of roles and responsibilities. This re-alignment helped to eliminate duplicative work and leverage individuals’ areas of expertise.
Driving Change Through Regulatory Processes
In tandem with the examination of regulatory functions, regulatory processes were mapped out to find areas for improvement and aimed at the pace and quality of submissions by aligning many processes.
In previous submission models, the regulatory workforce compiled submissions from various sources within the company, with pharmaceuticals and vaccines regulatory affairs having distinct and separate staffs and processes (Figure 1
). Submissions originated from either pharmaceuticals or vaccines regulatory affairs, and then all submissions packages went to local affiliates across the globe.
The affiliates conducted additional assembly activities, such as documentation and translations. Then, the affiliates submitted packages to local regulatory authorities for approval. In this process, a considerable amount of work was conducted by the affiliates at the very end of the submission assembly. After analysis, it became apparent that saving time, driving efficiencies, increasing control and reducing variation with a more centralized submissions process were key.
Figure 1. Former Regulatory Operating Model
In January 2015, the process of transitioning to a new centralized model called Global Regulatory Platform and Delivery (GRPD) began. More recently, an overall redesign of the submission process was completed (Figure 2
). With redesign, pharmaceuticals and vaccines regulatory affairs teams initiated the submissions process. Then, submissions preparation, translation and assembly were consolidated to be managed at five company locations around the globe. No substantive additional content was created by the affiliates as the affiliates’ main function became conducting the final review and submitting the packages to local authorities. The result is expected to provide less variance and redundancy in tasks, but with greater standardization and content control for optimal regulatory compliance.
Figure 2. New Regulatory Operating Model
Finding the right global locations (and an appropriately skilled workforce) for the centralization envisioned in the new model was critical for success. Starting with three locations—one in Poland and two in India—it quickly became apparent that more global capacity was required.
After assessing needs, costs and the ability to attract premium talent, several locations were added, specifically Mexico City and Cairo. The Mexico City affiliate serves as a focal point for Central and South America, with a workforce that has appropriate regional language capabilities. The Cairo location is a valuable and cost-effective site for regulatory operations work globally, with special emphasis on Arabic language capabilities for Middle Eastern markets.
Once regulatory transformation is completed and the global regulatory workforce is appropriately rebalanced between centers and affiliates, the majority of GRPD employees will stationed at the sites.
The next step was to design an internal communications strategy around sites to emphasize their equal importance in global operations, thus moving away from a “center/satellite” or “onshore/offshore” concept. This messaging helped achieve a buy-in for a ‘one vision’ rather than an “us versus them” mentality; one that could interfere with the teamwork necessary to achieve regulatory excellence. Regardless of site, employees are equally important team members within the organization. To date, the result is lower employee turnover and higher job satisfaction among employees across all sites.
Modernizing Regulatory Systems to Support a new Model
With the redesigned workforce and new processes in place, the last piece of the puzzle was to modernize technology. In 2017, the company conducted an internal inventory of clinical, regulatory and medical technology functions. At that time, the company maintained many on-premises systems. With the maturation of cloud-based applications for life sciences, there was increased interest in learning whether some of the discrete on-premises systems could be moved onto a small number of cloud platforms.
A modern Regulatory Information Management (RIM) suite of applications emerged and appeared to be critical for achieving further efficiencies in regulatory management, maintaining compliance with the new IDMP standards and producing greater internal alignment. RIM also would allow for “decommissioning” many legacy systems, all of which were costly to maintain and considered difficult to use by staff.
After investigation, including a due diligence assessment to ensure data security and privacy standards could be met, it was decided that one RIM platform could deliver on all of the identified needs. One deciding factor was the RIM’s ability to manage a single copy of data and documents through automated workflows. This reduced the number of steps in some processes by up to 80% (Figure 3
). Furthermore, estimates were that 70% of legacy systems could be replaced with the single cloud platform and, at the same time, gain an interface that is modern and accessible through mobile devices.
Figure 3. Simplified Process Steps for Writing CMC Variations
An agile implementation approach was developed, one different from standard software deployment, and the plan was to release functionality to users every three months to ensure the company delivered consistent and sustained value on investment. As a first step, documents were moved and processes related to labeling and archiving sent to the new cloud platform. Competency center employees were trained in how to use the application to conduct labeling more efficiently.
This regulatory transformation is expected to significantly reduce the number of, and even eliminate, tasks previously required for submissions planning through to approval. It is also anticipated many of the remaining tasks will be simplified the majority of the company’s legacy systems were replaced with a modern, cloud platform.
Employees previously noted that redundant and click-based tasks were major “pain points,” and by eliminating these issues and adopting modern technology, job satisfaction could be improved.
The following are some valuable points to consider:
- articulate a compelling vision and stay truthful to it
- keep value drivers in mind when making decisions at each step
- do not fear a complete redesign of people, processes and technology to achieve goals
- make changes swiftly to help create momentum and enthusiasm
- ensure all new technology supports business efficiencies
Moving through the process of regulatory transformation, the three original goals (efficiencies/effectiveness, quality/compliance and simplification/internal alignment) have helped maintain focus.
It has been confirmed that change must be decisive and communication must be compelling in order to create momentum and enthusiasm. By replacing the headquarters vs. satellite mantra with a holistic approach, a stronger team culture has been created and goals and processes have been aligned for greater efficiency.
With the maturation of cloud-based applications for RIM and a desire to both streamline and elevate regulatory operations, the time was right to embark on a journey of regulatory operations transformation.
About the Authors
Eckart W. Schwarz, MD
, is senior vice president of GlaxoSmith Kline’s (GSK’s) Global Regulatory Platform and Delivery (GRPD). He can be contacted at email@example.com
is vice president of technology, Clinical, Medical and Regulatory (CMR). He can be contacted at firstname.lastname@example.org
Schwarz E W and Cottrell A. “Transforming Regulatory Operations.” Regulatory Focus.
July 2019. Regulatory Affairs Professionals Society.