Product Information Outline Review Committee
Interview with Chairman Kondo
Promotional materials for pharmaceutical products delivered to healthcare professionals are the lifeline for supporting the proper use of pharmaceutical products and protecting patient safety. The Product Information Summary Review Committee plays an extremely important role in ensuring the reliability of the materials prepared by each company by reviewing whether they comply with the Pharmaceutical Manufacturers Association of Japan's voluntary standards for the preparation of such materials. However, the frequency of new drug development differs from company to company, and the transfer of skills and training of those in charge of preparing and reviewing materials is an issue common to the industry. To address this issue, we are taking a multifaceted approach that includes e-learning, "review meeting reports" that share case studies of issues raised, and training sessions. How can we create truly valuable information by raising the level of the industry as a whole and through co-creation with the medical field? We interviewed Mr. Mitsuhiro Kondo, Chairman of the Product Information Summary Review Committee.
Providing Appropriate Ethical Drug Information
Promoting Appropriate Promotional Materials
The biggest challenge to overcome is "human resource development
The mission of the Product Information Summary Review Committee is to deliver information on pharmaceuticals to healthcare professionals in an appropriate form. The main objective of its activities is to ensure that the promotional materials used for this purpose are appropriate in terms of content so that they comply with the "Code of Practice," the ethical code of conduct of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Specifically, a team including committee members and external experts in the fields of medicine and pharmacy reviews the in-house reviewed materials submitted by member companies at the time of approval of new drugs. This is not a voluntary system, and all member companies are subject to it. The reliability of the information is enhanced by double-checking by the company and us, based on the "Preparation Guidelines" established by the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Fortunately, in recent years, the number of findings in the review has been decreasing and the content has become more professional in level. We see this as proof that the quality of the industry as a whole is improving while building good relationships with our member companies. Through these activities, our role is to support our member companies in conducting appropriate promotional activities.
The biggest challenge facing the Product Information Overview Review Committee is human resource development. Not all of the 69 member companies are constantly developing new drugs. As a result, the experience of those involved in the creation and review of promotional materials varies greatly. This situation, which makes it difficult to transfer work and improve skills, is a problem that must be considered by the industry as a whole.
The problem is not limited to the "creators" and "reviewers" of materials. It is equally important to educate the "users" who provide information using the completed materials, such as MRs. No matter how correct the materials are, they are meaningless if the way they are conveyed is different from the facts.
To address this issue of human resource development, we are making various efforts. First, we have established an "e-learning system" that allows employees to continue to learn even when personnel changes occur. We have created an environment in which employees can view the necessary topics at any time.
In addition, we also issue "Audit Meeting Reports," which generalize the findings of the audits and share them with all member companies. In the past, there was a case in which it was pointed out that statements such as "only two adverse events" could lead to overlooking serious adverse reactions. By explaining these specific cases and reasons in detail from the background, we create opportunities for personnel from each company to learn from activities other than their own.
Filling the information gap through "co-creation" with the medical field
One of our future activities that we would like to focus on is "support for the internal review and training systems of member companies. One of the pillars of this effort is the holding of joint training sessions with medical institutions.
In the past, we have had the cooperation of outside experts, but this was only for the evaluation of submitted materials. Instead, we would like to create a place to share opinions on "what information is necessary" and "how the company's intentions are conveyed" from the perspective of medical professionals who actually use the materials in the field.
By bridging the gap between the intentions put forth by companies and the way they are received by healthcare professionals, the quality of materials and the level of internal review should improve dramatically.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) has adopted "co-creation" as a theme for realizing its vision. Co-creation is the key to our activities as well. In addition to co-creation within the committee, we would like to further increase opportunities for co-creation with member companies and healthcare professionals in the future.
The raison d'etre of our committee is to support our member companies and ensure that reliable information reaches healthcare professionals, ultimately contributing to the appropriate treatment of patients. To this end, we will continue our efforts to create a structure and system for the industry as a whole.
The structure and activities of the Product Information Outline Review Committee are posted on the website of the Pharmaceutical Manufacturers Association of Japan. Please visit the website.
[Product Information Outline Review Committee website]
Product Information Outline Review Committee | Japan Pharmaceutical Manufacturers Association