Topics Workshop on "Next Generation Adverse Reaction Case Evaluation Workshops" was held

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On October 19, 2023, the Pharmacovigilance Subcommittee (PV Subcommittee) of the Pharmaceutical Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) hosted a workshop on the theme of "Future Vision of Adverse Reaction Case Evaluation Work in the Next Generation - Thinking about the North Star of PV -" at the Nihonbashi Life The workshop was held at the Nihonbashi Life Science Building (Chuo-ku, Tokyo). The event was planned and organized by the members of the PV Subcommittee's Continuing Issues Team 2 (KT2), which is responsible for discussing issues related to regular safety surveillance activities and E2B (R3). The event was organized by the members of the Continuing Issues Team 2 (KT2), which is studying the issues of R2B (R3). More than 70 elite case evaluation professionals from various companies gathered to share their expertise and experience, providing a valuable opportunity to exchange information about the future of case evaluation.

Introduction

In the opening session, Makoto Morita, leader of KT2 of the Pharmaceutical Cooperative Association PV Subcommittee, enthusiastically explained the purpose of this workshop and its significant impact on the industry. Leader Morita emphasized the importance of the evolution of adverse drug reaction case evaluation work and the resulting changes in the industry, and asked all participants to adapt and innovate for the new era. During the closing session, Toshihiko Nishitani, Vice Chair of the Pharmaceutical Cooperative Association PV Committee, praised the success of the event and expressed his vision and expectations for the future. Vice Chair Nishitani thanked the participants for their active discussions and called for continued cooperation and commitment to the future development of the industry and the progression of technological innovation.

Details of Lectures

The presentation by Yumi Harada of Bristol-Myers Squibb featured case studies of RPA and AI implementation for databases. Ms. Harada detailed specific examples of AI and RPA use in the case evaluation process and the challenges associated with implementing these technologies. In particular, while focusing on the need to improve operational efficiency, he noted that several barriers exist to full automation and comprehensive use of AI. As an initial step in the automation process, he stated that the first step is to strengthen the system infrastructure, including its stability, and stressed the importance of utilizing current technologies. He also discussed approaches to both standardizing operations and ensuring regulatory compliance. He expressed his belief that the key to achieving efficiency gains with limited resources is to adopt feasible technologies first. This suggested an approach of implementing AI and RPA in stages and gradually improving processes.

The presentation provided an in-depth understanding of the impact that the introduction of AI and RPA technologies will have on case assessment operations and provided insight into the future role of these technologies in the industry. The importance of recognizing the challenges associated with evolving technologies and developing specific strategies to address these challenges was emphasized, providing participants with new perspectives.

FRONTEO's Shuhei Narita's presentation focused on digital transformation (DX) and the future of pharmacovigilance operations, delving deeply into the evolution of digital technology and its impact on modern drug safety assessment operations. He pointed out that drug safety information is shifting from traditional static snap data to continuous data (e.g., digital biomarkers) that are updated in real time, and emphasized that data analysis using RPA and AI is essential to address this change. He also touched on the importance of determining what points need to be changed and what will remain essentially unchanged in the process of business transformation through DX. Mr. Narita used the metaphor of AI as a "talented new graduate" and explained the importance of setting clear rules and specific goals and objectives for this "new graduate" to succeed. This metaphor suggests that although AI technology has advanced capabilities, it cannot reach its full potential without proper guidance and goal setting.

The lecture included a discussion of how pharmacovigilance operations should evolve and adopt technological innovations in the context of the larger trend of DX. The message was also conveyed that in order to effectively utilize advanced technologies such as AI and RPA, business processes need to be reviewed and a deeper understanding of these technologies is necessary. This gave participants a new perspective on the potential of digital technologies and their effective use in pharmacovigilance operations.

Overview of the group discussion

＜Discussion 1
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	What will happen to our business with the use of AI and RPA? Future vision of "What will happen to our business by using AI and RPA?

＜Discussion 2
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	What skills will we need to use AI and RPA in the future?
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	What can we do only by ourselves even if digitalization advances?

During the breakout discussion, participants were divided into 10 groups and enthusiastically exchanged views on their visions for the future use of AI and RPA in case evaluation work. A proposal by some groups for an "AI medical doctor who is available 24 hours a day, 365 days a year" received particular attention. With regard to seamless coordination of safety management information, many companies expressed their expectations for utilizing AI's capabilities, and many expressed their desire for standardization of data structures among medical institutions, companies, and regulatory authorities, as well as improvement of prompt and accurate information sharing. From the perspective of collaboration between humans and AI, some expressed the need for adaptation to national regulations regarding the reporting of individual case safety reports (ICSRs) and the establishment of a business continuity plan (BCP) in the event of an AI outage. Many groups expressed the view that in addition to basic medical and pharmaceutical knowledge and global regulatory expertise, an understanding of AI and RPA technologies, ethical judgment, and communication skills are essential for future case evaluators. In sum, participants shared their perspectives on what should be achieved for patients and had the opportunity to reaffirm their sense of mission and responsibility as case evaluators.

What we learned from the results of the post-event survey

Workshop insights

The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	The participants immediately shared examples of service utilization by their respective companies.
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	It was meaningful to learn that other companies are facing similar challenges and that solutions to these challenges have already been developed with a high degree of accuracy.
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	I realized that each company shares a common direction (the North Star) to aim for, and that if the objectives are the same, the diversity of approaches will promote constructive discussions. I strongly hope that face-to-face meetings will be held in the future.
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	There was a vague apprehension that AI would take away business operations, but the need to understand the nature of PV and to let AI learn was shared within the company.
The event concluded with a speech by Mr. Takafumi Adachi, Director of Public Relations.	Through discussions with other companies, we learned about the unused "Power Automate" feature of Office365 and hope to use it to improve business efficiency.

The workshop provided a number of practical case studies of case evaluation using AI and RPA technologies, and shared insights into the industry's vision for the future. These examples demonstrated the potential to not only improve operational efficiency, but also to improve quality and reduce risk. Participants explored how the introduction of these new technologies could transform case evaluation operations and what new possibilities they could open up. In particular, the automation of work through AI data analysis and RPA is expected to contribute to productivity gains across the industry and increase the accuracy and speed of case evaluation.

Closing Remarks

The workshop provided a lively exchange of information among the participants, who shared new insights into different perspectives and approaches within the industry. We hope that this exchange of information will help each company find solutions to the challenges they face and contribute to the creation of new approaches to case evaluation. And we believe that this interactive environment provided a valuable opportunity for participants to learn from each other's experiences and apply them to their own operations.

We, the planning and organizing members, are pleased that this workshop provided a good opportunity for case evaluation personnel to interact with each other and promote cooperation and growth in the industry as a whole. The feedback and input from the participants will serve as an important guideline for future industry activities. Based on these valuable inputs, we will continue to collaborate and promote new innovations for the development of our industry. We will continue to strengthen industry collaboration and improve the quality and efficiency of case evaluation through events such as this one.

( Naoki Matsumoto, Makoto Morita, and Toshihiko Nishitani, Continuing Issues Task Force 2, Pharmacovigilance Subcommittee, Drug Evaluation Committee)

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