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Posted 25 January 2017 | By Emily Huddle, Soufiane Dib, PharmD, Marie Claire Aquilina, MPharm,
This article discusses the impact of the Internet with regard to the amount and transparency of information offered by regulatory health agencies with an emphasis on the role of regulatory intelligence in monitoring the global environment and the subsequent communication obtained from this information.
Welcome to a wider world. Over the past two decades, the Internet has led to an unprecedented volume of readily accessible and seemingly endless information. In 2011, it was estimated people were bombarded with the equivalent of 174 newspapers (85 pages per newspaper) worth of information a day between exposure to the Internet, mobile devices and television.1 This reality is in stark contrast to when printed copies of the Federal Register were "snail mailed" on a daily basis as a bound book and often not received for several days to weeks following the publication date.2 The enormous capacity of the Internet created the push for increased transparency and access to public availability of information. In recent years, regulatory health agencies have demonstrated great success in answering this call for increased information via transparency initiatives and to communicate this information publically.
As the sources and types of information made available by the Internet continue to proliferate, the pharmaceutical industry also has broadened its focus to not only include patients in the traditional "key markets" of the ICH regions, but also into the Rest of World (RoW) segments, creating a truly 'global marketplace.' For the regulatory professional, the convenience of this instant access to ever-expanding, ever-evolving information presents a unique set of challenges in terms of successful navigation, monitoring and detection of important changes impacting the development, regulatory approval and post-marketing of pharmaceuticals.
In July 2016, the long anticipated proposed Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for FY 2018-2022 was issued by FDA for review and public comment.6,7 The commitment letter provided an important preview of what the industry can likely expect from the sixth authorization of the PDUFA. Those commitments impact a multitude of critical aspects for the industry including: employing the use of complex, innovative clinical study designs; further enhancements to sponsor-agency communication during drug development and review; and a framework for potential utilization of real world data for assessing safety and efficacy in regulatory submissions. This is only a small sampling of the proposed initiatives and associated commitments described in the letter.
In the event a company had dedicated staff or a regulatory intelligence function to monitor such developments, it could enable quick detection through diligent, daily monitoring and ultimately, consolidation into a concise, digestible summary containing points of relevance and impacts for the company. In the absence of dedicated staff to monitor, analyze and communicate this information, a possible scenario could be: the entire regulatory affairs department (and undoubtedly other groups outside of regulatory affairs) could have picked up on this important announcement and were possibly able—depending on individual workloads—to read the letter in its entirety and decide which critical aspects affected their individual roles. This second scenario describes a best case situation, but likely offers an unrealistic description of what likely occurs. This example suggests there are significant advantages and efficiencies for organizations with dedicated staff to monitor, distill, analyze and distribute intelligence to its impacted stakeholders.
In 2013, a survey of companies with a dedicated regulatory intelligence function was conducted to analyze measures such as demographics, responsibilities, internal partners and customers, as well as regulatory intelligence sources.8 Thirty-six companies invited from the US DIA Regulatory Intelligence Working Group and EU RING membership reported their companies had a dedicated regulatory function and 29 of the companies (an 80 percent response rate) elected to participate in the survey. From the responses, 69 percent of the companies reported the dedicated function contained five staff members or less and 69 percent of the dedicated groups were responsible for one or more geographic region with 100 percent of groups monitoring the US and EU and more than 85 percent indicated coverage was global for all other regions - Figure 1.
Sixty-six percent (n=19) of the companies that responded to the survey had more than 10,000 employees. This relatively small investment plays a significant role in monitoring for changes with wide-ranging impacts, including compliance and regulatory decision-making as well as identify opportunities to influence the external regulatory environment through regulatory commenting. It is noteworthy that most individuals within the regulatory intelligence function have responsibility for monitoring one or more regions, further validating the efficiency of having a dedicated function. While the information delivered to each of the regions is often specific only to that particular region, the overall deliverables the function provides to an organization share many similarities across the regions. Summarized from the survey, Figure 2 depicts the common deliverables dedicated regulatory intelligence functions identified as their primary responsibilities. The top five deliverables, including providing regulatory information, education, actionable intelligence, news alerts and developing/coordinating comments on consultation documents issued by regulatory health authorities, were reported in more than 86 percent of the functions surveyed.
Due to these similarities in the expectations of the various regulatory intelligence counterparts deliver for their regions, there are many advantages to the global alignment of resources, systems, tools and processes that can be shared inter-regionally.
The size and budget of an organization may dictate the resource amount employed to monitor regulatory information from subscription-based, regulatory intelligence databases or utilizing free, on-line tools, such as Google alerts or listserv email subscriptions. Regardless of which tools are employed, sharing best practices regarding effective ways to monitor regulatory changes is a clear benefit to working inter-regionally. In addition, external subscriptions to pharmaceutical news sources, regulatory intelligence databases and other sources of regulatory information also provide opportunities for effective cost-sharing of subscription fees across an organization. Enterprise-wide access to regulatory intelligence resources also can provide a valuable benefit to individuals who sit outside of regulatory intelligence functions, in terms of promoting a self-service model to obtain common types of regulatory information (e.g., approved competitor labels, agency guidance and country regulations).
After the analysis of regulatory information, turning it into actionable intelligence is central to demonstrating the value of a regulatory intelligence function within an organization. In order to perform this critical step effectively, a solid understanding is needed of the company's development pipeline, therapeutic and disease areas of interest, approved product portfolio, current development strategies, and current regulatory hurdles, in addition to the many other potential constantly changing factors. As the regulatory intelligence professional effectively understands these priorities, she/he is able to filter out what is relevant as well as summarize and expand on the potential impacts and implications specific to their company. A listing of priority regulatory topics and therapeutic/disease areas of focus can be shared inter-regionally to ensure consistency in what types of information are being monitored. Similar considerations can be given to determining potential impacts and implications. Acknowledging that in some instances the priorities of a company may vary among the regions, a shared list may not always be practical. This is especially relevant in terms of regional regulatory health agency priorities. While the various agencies have made significant strides in inter-regional collaborations, harmonization in some areas is still evolving, meaning regulatory intelligence professionals can only align inter-regionally on a regulatory topic and on the condition that it is already consistent between the regulators. Areas of transparency, which vary between EU and US regions, may stand as an example. FDA Advisory Committees are announced in the US Federal Register at least 15 days in advance of the upcoming meeting date; the announcement includes a proposed agenda as well as options for public viewing of the meeting and associated meeting materials. In contrast, the EMA does not release details on any of their discussions, but for the final decisions following the meeting. Conversely, there are advances in transparency in the EU which are not in place in the US, such as the release of list of products currently under evaluation for marketing authorization, negative decisions on products and sponsor clinical study reports for approved products.
Communicating regulatory intelligence is an essential role. This communication can be diverse in terms of format and media used by the different personnel across the regions. Communication is the main output for a regulatory intelligence function, and as information is often disseminated broadly throughout the company, it is a direct representation of the function. Consequently, it is important to maintain a consistent approach to communication of information to ensure both reliable interface with the company and internal continuity within the regulatory intelligence team. How the regulatory function evolved regionally may affect how the team's influence may vary from one region to another. Some members of the team may communicate more frequently by email or online communications, while others may have increased face-to-face interactions due to historical background of the regulatory intelligence function and physical locations. Common communication methods are critical to translating information into valuable intelligence for the rest of the company. Using common alerting templates allow for the information to be presented and formatted in a consistent manner, ensuring the main points and impact to the company are emphasized appropriately. In addition, utilizing central distribution lists for regulatory intelligence communication ensures a broad reach to the appropriate process owners, experts and other internal stakeholders. Communication methods also could include interactive sessions, dependent on the regional capacity and practices of the regulatory intelligence function. However, global alignment of this type of communication would be beneficial as it would be easily identified within the company as a dedicated, established forum for the communication of important regulatory intelligence topics and discussions.
While email is a commonly used method to quickly and efficiently disseminate information to large audiences, email is not an optimal solution for long-term storage and retrieval. Following the communication of regulatory intelligence to stakeholders, there are many advantages to storing this information in a central repository inter-regionally. An example of such a repository could be a web application platform using standard web browsers allowing for secure storage, organization, sharing and accessing information. Depending on the platform, there are various ways entries can be categorized using meta-data fields to enable customized searching and filtering to more easily retrieve the information. In addition, databases often offer longer retention periods than an email account with limited storage capabilities.
The International Conference on Harmonization (ICH) is an organization gaining increased significance as the number of regulatory members continues to grow and align their processes with ICH guidelines. A consolidated, global approach to responding to ICH draft guidelines is advantageous for ensuring guidelines are developed to promote increased alignment across the regions. When regulatory intelligence functions limit the coordination, collection and submission of comments on a draft guideline to their respective regions, there is the inherent risk the submission does not adequately reflect the position of all internal experts within the company and inconsistent, potentially divergent views may be expressed within the separate regional submissions. Developing a common process for responding to proposed guidelines allows the regulatory intelligence function to facilitate a global commenting process, resulting in a single, consistent company position to prevent any possible contradictory messages. Additional tools for inter-regional use in the commenting process include: listings of internal global subject experts and other stakeholders, common templates for authoring and/or submission and shared review and approval steps.
Irrespective of organizational reporting lines, there are many advantages to sharing resources, systems, tools and processes inter-regionally across regulatory intelligence staff. As the 2013 survey demonstrated, regulatory intelligence functions often have very similar deliverables in the provision regulatory information, education, actionable intelligence, news alerts and developing/coordinating comments on consultation documents. In companies with dedicated staff to perform regulatory intelligence functions, these groups are relatively small in comparison to the respective sizes of their companies. These individuals are often tasked with monitoring multiple regions and are responsible for providing global coverage to their organization. With this considerable and significant responsibility, sharing best practices with global colleagues, along with shared processes and tools, can promote further efficiencies that translate into the delivery of more effective and impactful regulatory intelligence for an organization.
Emily Huddle, BSc, is US regulatory intelligence manager for Gilead Sciences, Inc. and co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including nine years in regulatory intelligence. She can be contacted Emily.Huddle@gilead.com.
Soufiane Dib, PharmD, is EU/international regulatory intelligence manager for Gilead Sciences, Inc. Dib has worked in the pharmaceutical industry for the past seven years. He can be reached at Soufiane.Dib@gilead.com.
Marie Claire Aquilina, MPharm, MSc, is EU/international regulatory intelligence associate II for Gilead Sciences. Aquilina has worked in regulatory affairs for the past two years and prior to Gilead, she worked as a community pharmacist and for the Ministry of Health in Malta dealing with pricing/reimbursement issues. She can be contacted at MarieClaire.Aquilina@gilead.com.
Cite at: Huddle, E., Aquilina, M.C. and Dib, S. "Regulatory Intelligence—Delivering Regionally, Operating Globally." Regulatory Focus. January 2017. Regulatory Affairs Professionals Society.
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