P106: Understanding of Drug Approval/Disapproval Decisions and Accountability - Development and Results of a Training Program

Poster Presenter

Toshiko Ishibashi

Oncology Medical Science Department, Medical Affairs Division
Daiichi Sankyo Co., Ltd.
Japan

Objectives

To develop and evaluate the Regulatory Communication training aimed at understanding approval/disapproval decisions impacting stakeholders from healthcare workers and patients to developers, regulators, media, and the public.

Method

A model training program was developed to determine whether to approve or disapprove of a fictitious drug and to hold various stakeholders accountable for the rationale behind the approval or disapproval. The usefulness of the program was verified based on participants' feedback.

Results

Participants for this training course were recruited via the DIA Japan platform. Participants came from various backgrounds, including pharmaceutical companies' regulatory and R&D departments, academia, and regulatory authorities. The total number of participants throughout ten sessions was 288. Feedback from participants indicated that the training program proved to be a significant tool in equipping participants with the ability to comprehend the scientific reasoning underlying approval/disapproval decisions and to communicate these effectively to various stakeholders. Throughout the program, participants identified and established the fundamental principles and standards necessary to fulfill their accountability toward addressing various expectations and concerns raised by stakeholders. Furthermore, the program facilitated an easier understanding of diverse stakeholders' perspectives, including patients, healthcare institutions, regulatory authorities, academia, the general public, and the media. Through these experiences, participants comprehensively understood the appropriate approach to constructing application materials, identifying critical concerns during the review process, developing suitable protocols, and understanding the necessary data construction. These benefits indicate that the program was successful in its aim to deepen understanding of the decision-making process and accountability in drug approval/disapproval.

Conclusion

Through a decade of development and implementation, the Regulatory Communication training became a significant platform to learn about decision-making and accountability in drug approval reviews. This program strengthened the ability to clarify and organize the basis for fulfilling accountability, enhancing transparency and efficiency in the review process, and contributing to the mindset when planning development.