Drug Evaluation Committee Workshop on "People x Technology x Future - Our Vision for the Next Generation of Pharmacovigilance

Pharmacovigilance Subcommittee

April 2026

Introduction

On Wednesday, February 25, 2026, the Pharmacovigilance (PV) Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) hosted the "People x Technology x Future: Our Vision for the Next Generation of Pharmacovigilance" workshop in a face-to-face format at the Nihonbashi Life Science Building (Chuo-ku, Tokyo). The workshop was held in Nihonbashi Life Science Building (Chuo Ward, Tokyo). The workshop was planned and organized by members of the Continuing Issues Team 2 (KT-2), which discusses regular drug safety surveillance activities and E2B(R3) issues in the PV Subcommittee, and was mainly aimed at the safety departments (especially those in charge of adverse drug reaction case evaluation) of Drug Evaluation Committee member companies. The survey was conducted mainly for the safety departments (especially those in charge of adverse drug reaction case evaluation) of member companies of the Drug Evaluation Committee.
The collection, evaluation, and reporting of adverse drug reaction cases (case evaluation) in pharmaceutical companies not only responds to regulatory requirements, but also plays an important social role in supporting medical practice and patient safety. On the other hand, the environment surrounding case evaluation operations has been changing dramatically in recent years with the development of AI (Artificial Intelligence) and automation technologies, as well as the expansion of medical DX (Digital Transformation) and RWD (Real World Data) / RWE (Real World Evidence) utilization. The environment surrounding the case evaluation business is changing drastically. In the midst of these changes, this workshop was planned to provide an opportunity for case evaluation staff to organize their own work and future vision from the three perspectives of "people," "technology," and "future," and to think proactively about the next generation of PV work (especially case evaluation work).
On the day of the workshop, 52 participants from 35 companies attended.

Overview of the workshop (program structure)

The workshop was conducted as follows

Keynote speech: Latest trends in AI and automation technologies and their potential use in PV operations

Mr. Hikaru Mizuno, PwC Consulting, LLC
In his opening keynote speech, Mr. Mizuno of PwC Consulting, LLC gave an input on the current trends and future possibilities of AI and automation technologies under the theme of "The latest trends in AI and automation technologies and their potential for use in PV operations - to become people who continue learning and creating value. He gave his input on the current trends and future possibilities of AI and automation technologies.

Group discussion: 3 starting points (future, technology, people) x 3 act structure

After the lecture, participants were divided into several groups for discussion. The discussion was structured from the three perspectives of "future," "technology," and "people," and was designed to deepen the discussion in the first and second acts, followed by individual work in the third act, which was incorporated into the "Kira Kira Declaration (declaration of action).

Group presentations (sharing)

After the discussion, the results of each group were shared among the audience. Representative groups gave brief presentations of their perspectives gained from the group discussions, providing an opportunity for participants to gain hints for considering future actions. Furthermore, in response to the presentations, Mr. Nishitani and Mr. Morita, vice chairpersons in charge of KT-2, expressed their determination to continue to face and address issues that may arise in the future for the industry.

Results of post-workshop questionnaire

The post-workshop questionnaire conducted after the workshop (questionnaire period: February 26 - March 13, 2026) yielded the following results.

In terms of learning and awareness, the following issues were frequently raised.

Concluding Remarks

In this workshop, based on a multifaceted discussion frame from the three starting points of "future," "technology," and "people," participants discussed the possibility of AI utilization in the next generation PV-Pharmacovigilance co-creating with AI, based on the current situation of their own and other companies. The "Kirakira Declaration" provided participants with an opportunity to take concrete N-row actions. The results of the questionnaire showed that the overall satisfaction level was high, and the group discussion was particularly highly rated, confirming that sharing information and gaining perspectives with other companies was perceived as a significant value.
Based on the lessons learned and suggestions made this time, we will continue to consider providing opportunities for each participating company to exchange information that contributes to practical work and the growth of the next generation of PV human resources.

Drug Evaluation Committee, Pharmacovigilance Subcommittee, Continuing Issues Response Team 2
Workshop planning members: Hiraizumi, Matsumoto, Onaki, Yoshihara, Tamai
Workshop organizing members: Kawakami, Ogawa, Chihara, Fujitsuka, Mori, Wakabayashi, Nakamura, Kawaguchi, Nishitani, Morita

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