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Activities of the Kansai Pharmaceutical Industries Association (KPIA)

   
1. Pharmaceutical Regulatory Affairs Committee
Established on September 1, 1948
 

The Pharmaceutical Regulatory Affairs Committee promotes members’ compliance with the Act on Securing Quality, Efficacy and Safety of Pharmaceutical Products and Medical Devices (the Pharmaceuticals and Medical Devices Act: the PMD Act). It has formed task forces, each assigned to a specialized field, including legislation, pharmaceutical regulatory affairs, advertising and labeling, OTC drugs, and pharmaceutical regulatory laws in other countries, to discuss systems related to pharmaceutical laws and regulations, and problems found in the course of operation by member companies.

The Committee also actively participates in projects of the Pharmaceutical Regulatory Affairs Committee of FPMAJ, in which KPIA participates as a member, to address problems related to the PMD Act.

In FY2020, the Committee will focus on the following activities:
(1) Strengthening of the committee’s functional activities such as research study and proposals related to pharmaceutical laws and regulations
With the promulgation of the revised PMD Act in December 2019, we will collect and study information regarding the PMD Act so that we can appropriately respond to the operation of the administrative ordinances, notices, etc. associated with the PMD Act that will be issued in the near future. In addition to the activities mentioned above, to solve problems faced by member companies in practicing pharmaceutical businesses in accordance with the PMD Act, the Committee will collect opinions and requests from member companies, and conduct research study to identify problems in pharmaceutical business practice. Based on these activities, the Committee will make requests to relevant administrative agencies via FPMAJ to issue notifications that clarify how such problems should be handled.

It will also compile a proposal that summarizes requests from member companies regarding pharmaceutical and healthcare regulations and requests for support and incentive measures. It will present this proposal to the relevant public agencies in opinion exchange meetings and other occasions. It will also cooperate with local governments, wide area administrative union, and other related organizations in the Kansai Area, in presenting proposals related to national pharmaceutical regulatory and medical programs, such as national strategic special zones.

(2) Proactive proposals regarding measures that will help the development and growth of member companies and proposals regarding rationalization of regulations
The Committee will make proposals for rationalization of regulations and systems to match the globalization of pharmaceuticals and related products. It will also conduct research and examination, and make proposals regarding modification of regulations to accelerate the introduction of next-generation medical treatments such as regenerative medicines and the launch of new healthcare products. It will also consider and make proposals to the Kansai Branch of PMDA regarding the expansion and active utilization of its functions and utilization of these functions to new areas.

(3) Cooperation with officers in charge of pharmaceutical regulations in the Osaka Prefectural Government and other local governments
The Committee will keep contact with officers in the pharmaceutical regulatory affairs section of the Osaka Prefectural Government and other local governments to deepen the mutual understanding about pharmaceutical regulations, and conduct activities as a local trade organization. It will also create opportunities to periodically exchange information and opinions with these officers to share information and conduct research and have discussions with them regarding problems in the pharmaceutical regulatory system and its operation. Based on these activities, it will make proposals to MHLW or PMDA in cooperation with the pharmaceutical regulatory section of the Osaka Prefectural Government.

(4) Cooperation with MHLW and PMDA
The Committee will collect opinions and requests from member companies regarding problems they have found in practicing their operations, such as the examinations for approval of drugs (approval of new drugs and partial changes), investigations (document and site investigations, investigation to confirm GMP compliance), consulting services (face-to-face advice, simplified consulting, etc.), procedures to accept documents (such as a clinical trial plan, a report of minor change, report of manufacturing of medicines for export (or report of import)), import/export procedures under the PMD Act, and research and development activities. Based on these opinions and requests, the Committee will propose improvements to MHLW and PMDA.

(5) Activities by task forces and working groups
1) Research and study on the PMD Act and other related subjects
Task forces and working groups under the Committee will conduct research and study activities related to the PMD Act and related laws and subjects, such as:
- Matters related to drug wholesalers (guidelines/guidebook, PIC/S-GDP, etc.);
- Matters related to pharmaceutical manufacturers (PIC/S-GMP, data integrity, references when a registration application of a foreign manufacturer is submitted, etc.);
- Matters related to registration application (PMDA consultation system, application with CTD for generic drugs; points to consider when describing a manufacturing method; simplified description of specifications and testing methods; control of residual solvents; inspection of GMP compliance, etc.);
- Matters related to OTC drugs (Application, marketing, GMP, etc.)

2) Research study on pharmaceutical regulatory systems in other countries
Mainly focusing on drug approval systems in the U.S., Europe and Asia (especially China), a task force under the Committee will conduct research and study on drug regulatory systems in other countries, to promote sharing of information among member companies regarding needs for medical and healthcare and information about regulatory authorities and systems in other countries. It will also promote exchange of information with JPMA and other organizations.

3) Research study on regulations of drug development
A task force under the Committee will conduct research study, from the viewpoint of pharmaceutical regulations, regarding pharmaceutical regulatory strategy and examination and investigation for approval mainly focusing on products with new active ingredients, and daily regulatory affairs for drug development.

4) Research study on advertisement and labeling
A task force under the Committee will conduct research study regarding labeling, inserts, interview form, and outline of product information brochure, advertisement (websites, trade magazines and newspapers, TV and other media), distribution codes of prescription drugs, technologies to prevent counterfeiting and contaminations of foreign matters by sealing and packaging materials and some others, and present opinions and requests based on these studies.

5) Review and revision of the Drug Approval and Licensing Procedures in Japan
Regarding the publication of the Drug Approval and Licensing Procedures in Japan 2021, a task force under the Committee will review and make necessary revisions to ensure members’ compliance with the latest regulations and to further improve their business practice, by adding new regulatory requirements, administrative notifications, reporting and other necessary matters in the Guideline.

6) Improved usability and functional enhancement of PRAISE-NET
A task force under the Committee will make proposal to improve the database of pharmaceutical-related administrative notifications provided by PRAISE-NET and to improve the usability and function of its notification search service. It will also improve the database by identifying problems in the database of pharmaceutical regulatory affairs information currently made available via PRAISE-NET to members of the Pharmaceutical Regulatory Affairs Committee and some others.

(6) Holding of workshops and seminars
The Joint Pharmaceutical Regulatory Affairs Committee between KPIA and PMAT will be formed. It will host a seminar on the latest movement in pharmaceutical regulations by inviting officers from MHLW and PMDA. Workshops and seminars related to business practices and compliance of committee members and task force members will be conducted. Workshops and seminars on specialized subjects of individual task forces will also be conducted.

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2. Technical Research Committee
Established on September 1st, 1948
 

The Technical Research Committee will participate in the Japanese Pharmacopoeia Expert Committee (hereinafter the “Expert Committee”) in PMDA and cooperate in the preparation and revision of the Japanese Pharmacopoeia. The Committee will make the efforts to achieve the consistency of understanding in the method of quality evaluation, specifications and test methods for pharmaceutical products between the administrational agencies and the Pharmaceutical Industry, and participate in the research granted by the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ) so that the member companies can utilize the Japanese Pharmacopoeia properly.
The Committee will also address and solve technical issues occurred in the Japanese Pharmacopoeia and the marketing approval application for pharmaceuticals through activities by working groups organized under the Committee, provision of technical information to the member companies, and cooperation/ coordination with other related committees.

In FY2020, the Committee will focus on the following activities:
(1) Cooperation in the revision of the Japanese Pharmacopoeia
The Committee will dispatch its associate members and expert members to the Expert Committee and working groups organized under the Expert Committee.
The Committee will contribute to the improvement, reinforcement, international harmonization and globalization of the Japanese Pharmacopoeia by making requests and presenting opinions to the relevant administrational agencies in accordance with the Basic Policy for Preparing the 18th edition of the Japanese Pharmacopoeia issued in October 2016.
The Committee will solve the practical issues related to the Japanese Pharmacopoeia in cooperation with other related organizations and committees so that member companies can properly operate and utilize the Japanese Pharmacopoeia .

(2) Working group activity
The working groups organized under the Committee will solve technical issues for the quality evaluation methods for pharmaceuticals. The performance will be shared with the member companies by reporting the details of their activities at the quarterly regular meetings.
The Bio-Pharmaceutical Product Working Group will continue its activities to research the quality evaluation method, specifications and test methods and other matters for bio-pharmaceutical products.

(3) Provision of technical information
At the quarterly regular meetings of the Committee, the conclusion and points of discussion in the Expert Committee will be reported to the member companies and the progress of the revision for the Japanese Pharmacopoeia will be also shared with them.
Furthermore, the Committee will plan and hold lectures and explanatory meetings to provide the information on the Japanese Pharmacopoeia so that the member companies can deepen understanding of the Japanese Pharmacopoeia.

(4) Participation in the research granted by the Pharmaceutical and Medical Device Regulatory Science Society of Japan (PMRJ)
The Committee will apply for the research granted by PMRJ to address and solve the issues on revision of the Japanese Pharmacopoeia.

(5) Action to technical issues related to ICH-Q3D
The Committee will solve issues related to ICH-Q3D in close collaboration with relevant organizations and committees.

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3. Quality Committee
Established on July 1, 1973

 

To improve the quality assurance systems for pharmaceutical products, the Quality Committee will work to collaborate with Osaka Prefectural Government and other local governments in the Kansai region, and promote information exchange and mutual enlightenment regarding GQP and GMP related information with relevant business organizations and committees in pharmaceutical trade organizations such as FPMAJ, and the member companies.

In recent years, quality assurance systems for pharmaceutical products have been improved to be globally consistent, and scientific and logical proposals and discussions are required on ordinances, notifications and guidelines regarding GQP and GMP (including GDP). The Committee will actively make proposals related to these matters to the administrative organizations through FPMAJ.

The Committee will identify issues in relation to the inspection/guidance of GQP/ GMP and their operation including GDP, and make requests or proposals to MHLW and PMDA though FPMAJ and Osaka Prefectural Government to solve the issues and develop mutual understanding between the government and the pharmaceutical industry.

In FY2020, the Committee will focus on the following activities:
(1) Cooperation in the development of the administrative ordinances, notifications, etc. in accordance with the promulgation of the revised PMD Act
- Make requests or proposals about the formulation of administrative ordinances, notifications, etc. associated with the Committee

(2) Identification of the issues and proposals in relation to the inspection/ guidance of GQP/ GMP and their operation including GDP
- Partial revision of GMP Notification, and revision of administrative ordinances on GMP and case studies for GMP
- Revision of PIC/S GMP Guide and these Annex
- Other administrative notifications from MHLW or the Osaka Prefectural Government, etc. related to GQP/GMP/GDP

(3) Promotion of cooperation with local governments mainly in the Kansai region
1) Promotion of cooperation with the Osaka Prefectural Government
- The Committee will ensure common understanding regarding problems about issues related to GQP/GMP/GDP through periodical information sharing and exchange of opinions with the Osaka Prefectural Government, and work to solve the issues
- The committee will continue to participate in the Standard Evaluation Examination Sectional Meeting for pharmaceutical products under the Osaka Prefecture Pharmaceutical Affairs Council and provide opinions about issues of GQP/GMP
- The Committee will participate in the Meeting for Pharmaceutical Regulation Rationalization and the Quality Working Group of the Osaka Prefectural Government to develop mutual understanding and strive to solve any issues related to regulatory affairs, approval procedures, and the inspection/guidance pertinent to pharmaceutical products

2) Promotion of cooperation with the GMP Team under the Pharmaceutical Affairs Division Manager Meeting in the Kinki region
The Committee will work to cooperate in the activities of the GMP Team comprised of the Chiefs of Pharmaceutical Affairs in the Kansai region and proactively exchange opinions to enhance the partnerships with local governments.

(4) Activities toward problems in the business practice
Three Task Forces (The Quality System Research Task Force, the Software Case Study Research Task Force, and the Education Task Force) will review and consult problems in the business practice to devise solutions. The research subjects for individual task forces in FY2020 are as follows:

 Quality System Research Task Force:
Quality Risk Management
 Software Case Study Research Task Force:
Knowledge management
 Education Task Force:
Development of “Real-World Cases of Deviation and Appropriate Responses”(tentative title) and “GMP for Pharmaceutical Products (4th edition)”

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4. International Business Committee
Established on April 1, 2014
 

The International Business Committee supports international business activities of member companies, with an aim to further promote global expansion of Japanese pharmaceutical related industries. The Committee will collaborate with the Secretariat to promote a global development of the pharmaceutical related industries by supporting overseas business development (international business activities) of the member companies.

In FY2020, the Committee will focus on the following activities:
(1) Strengthening of the cooperation with overseas partners to achieve improved access, including the establishment of pharmaceutical related value chains
Among overseas countries, particularly Asian economies (China, India, Korea, Taiwan, ASEAN, etc.) are important suppliers of APIs, etc. Due to their economic growth, the Asian market is expected to expand substantially in the future.

The Committee will conduct seminars/lectures and match-making/net-working meetings on pharmaceutical related value chains focusing on these regions, and contribute to the improvement of local access to pharmaceutical related products by sharing and raising issues with the Japanese and local governments. Regarding the Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization, the Committee will promote cooperation with FPMAJ to achieve the Grand Design. Regarding Europe and the USA, as it is important for the member companies to understand pharmaceutical related R&D and regulatory trends in these areas, the Committee will continue to collect information and hold seminars and lectures related to these areas.

(2) Exchange with bio-clusters and start-ups in overseas countries
In cooperation with the Osaka Prefectural Government, other local governments and related organizations (such as the Foundation for Biomedical Research and Innovation at Kobe, and Senri Life Science Foundation), the Committee will hold business net-working meetings, lectures and other exchanges with overseas biotechnology clusters and start-ups.

(3) Activities in cooperation with local governments and consulates
The Committee will strengthen cooperation with overseas governmental agencies and trade organizations, the Embassy and the Consulate General in Osaka, MHLW/PMDA, competent departments of local governments, JETRO, the chambers of commerce and industry in Osaka, Kyoto and Kobe, the Kansai Economic Federation and international committees of FPMAJ, JPMA and the Japan Self-Medication Industry Association (JSMI), and hold conferences and networking meetings aimed at overseas business expansion of member companies.

(4) Promoting information sharing on healthcare needs, regulatory authorities and systems, etc.
The Committee will develop a system to share information among member companies including healthcare and medical needs, regulatory authorities/systems, business and investment environment in mainly Asian countries which member companies are interested in.

(5) Development of globally competent human resources
In order to promote overseas business development in the pharmaceutical field, it is essential to develop and retain global human resources. The Committee will identify their needs to support for developing and retaining globally competent human resources, and examine the measures needed.

(6) Strengthen the information distribution function
The Committee will strengthen efforts to disseminate the information about our activities to overseas stakeholders by reviewing and enhancing the contents of our English website which introduces our activities and some others.


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5. Eye Drops Study Group
Established on July 1, 1977
 

The Eye Drops Study Group conducts research and study on problems in pharmaceutical regulations and technical problems related to eye drops, and prepares and proposes measures to solve these problems. The Study Group also conducts activities requested by the government or trade organizations of pharmaceutical manufacturers, such as research and examination on problems related to eye drops and proposal of solutions, aiming to contribute to improvement of the quality of eye drops and enhancement of the level of the industry. The results of its activities are published on the KPIA website and other publications to widely disclose them to not only the member companies, but also to the public.

In FY 2020, the Study Group will continue to study on enlightenment of proper use of eye drops, correspond to the administrative documents and notifications, and research on ophthalmic regulations and their quality issues.

In FY2020, the Study Group will focus on the following activities:
(1) Research regarding education on proper use of eye drops
The Study Group will continue to promote the utilization of a “Handbook for Pharmacists”, a “Pamphlet for Patients/General Consumers” and a “Panel for Elementary School Children Regarding Education on Proper Use of Eye Drops” created to ensure and educate on properly use of eye drops as educational materials in FY 2020.

(2) Activities to address official documents and government notifications
The Study Group will examine matters requested by FPMAJ and JSMI. Such requests include a review of approval criteria for manufacturing of ophthalmic preparations; research on revision of the Japanese Pharmacopoeia General Provisions, the general testing method and reference information; matters related to prevention of medical accidents; publication of cases in the GMP case book, and research related to notifications issued by the government.

(3) Research on problems in pharmaceutical regulations and quality of eye drops and actions to address these problems
The Study Group will hold plant tours and study sessions in conjunction with questionnaire surveys and opinions exchange with member companies to identify and analyze problems in pharmaceutical regulations, production management and quality management of eye drops. It will also standardize interpretation and terminology, and consider measures to address these problems, aiming to support learning of knowledge and skills.

(4) Cooperation with the Eye Drops Study Group of PMAT
To gather opinions from the eye drops industry and facilitate making proposal to the government and trade organizations, the Study Group will cooperate with the Eye Drops Study Group of PMAT in conducting joint report meetings on the results of research study and joint opinion exchange meetings. The Study Group will hold workshops and study sessions, including tours to production sites of pharmaceutical products and other subjects. It will also conduct opinion exchange meetings with member companies, with an aim to improve learning support provided to member companies of the KPIA’s or PMAT’s Study Group and improve the quality of their general knowledge and skill related to pharmaceutical products.

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6. Intellectual Property Study Group
Established on February 1, 1956
 

The Intellectual Property Study Group supports intellectual property activities of member companies. The Study Group establishes each task force in the field of patent, patent information and trademark, respectively. Each task force selects research topics to collect information and conduct practical studies regarding intellectual property information including patents/trademark examinations/trials related to pharmaceuticals. The Study Group also has a meeting to discuss the various IP issues with the Japan Patent Office (JPO) or other relevant agencies, in cooperation with the Intellectual Property Study Group of PMAT. Utilizing IT, it distributes information and results obtained by these activities to member companies.

In FY2020, the Study Group will focus on the following activities:
(1) Patent Task Force
The Task Force will study various issues concerning patent systems in Japan and overseas.
The Task Force will collect and review information in a timely manner, mainly regarding practical aspects of examination and appeal by JPO as needed with paying attention to the revision of the Patent Act or the trends after Examination Guidelines to provide member companies with results of these activities. Hearing opinions from member companies, the Task Force will submit requests and offer opinions to the JPO or other relevant government organizations, in cooperation with Intellectual Property Study Group of PMAT as necessary.

The Task force will also collect the pharmaceutical related information as well as court precedents and theories related to the patent law in Japan and other countries, and conduct research and analysis on the information. Taking into consideration new partnerships with industries, government and academia that contribute to creation of innovations, it will identify problems to be solved in pharmaceutical industries and propose actions to address these problems.

(2) Patent Information Task Force
The Task Force will conduct research and study on intellectual property information in and outside Japan, mainly on patent information.
The Task Force will conduct research and study generally on the utilization of information related to intellectual property in and outside Japan, including the search services/technology/scheme that use advanced IT technologies. The Study Group compiles the results of these activities into a summary and provides member companies with them to meet their practical needs. Hearing opinions from member companies, the Task Force submits requests and opinions to patent offices in Japan or other countries or the providers of court precedents/ intellectual property information database services, in cooperation with the Patent Task Force of the KPIA's Intellectual Property Study Group or the Intellectual Property Study Group of PMAT as necessary.

(3) Trademark Task Force
The Task Force will study various issues concerning trademark systems in Japan and overseas.
The Task Force will collect and review information mainly regarding practical aspects of examination as needed with paying attention to the revision of the Trademark Act or the examination and appeal status after Examination Guidelines to provide member companies with results of these activities. Taking into consideration business development by brand protection and hearing opinions from member companies, the Task Force will submit requests and offer opinions to the JPO or other relevant government organizations, in cooperation with the Intellectual Property Study Group of PMAT as necessary. Depending on the situation, it will also conduct research and analysis of court precedents and theories related to the trademark law in Japan and other countries and identify problems to be solved in the pharmaceutical industry to propose actions to address these problems.

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7. Medical Information Service Study Group
Established on February 1, 1995
 

The Medical Information Service Study Group has handled problems occurring in customer service departments of pharmaceutical companies that directly receive calls from medical professionals such as doctors and pharmacists, general consumers and patients. The Study Group works to improve our skills and acquire a wide range of peripheral knowledge as well as the knowledge of the company's own products so that we can respond to a wide variety of inquiry needs. In recent years, the Study Group also works to gather skills and information needed to deal with the elderly, physically disabled, and foreigners visiting Japan. The Study Group will continue to improve the knowledge of member companies to meet the changing needs of customers as society changes. The Study Group will study to be able to provide appropriate information in accordance with the "Guidelines for Sales Information Provision Activities," which has been in full effect since last October.

In FY2020, the Study Group will focus on the following activities:
(1) Research activities of the entire Study Group and activities of individual task forces
The Study Group will work to promote mutual understanding among the member companies by feeding back to the members the information obtained through the attendance of the representatives from the “Task-force Meeting for Medical Information Service” hosted by PMDA and the Task-Force Meeting for Medical Information Service under the Pharmacovigilance Study Committee of FPMAJ.
The Study Group will form the Information Review Study Working Group and the Case Study Working Group under the Study Group, and make great efforts with mutual study as well as self-study through monthly regular meetings of these groups.

The Case Study Working Group will work to improve the communication skills through investigation of consultation cases and feed their results back to the member companies so that they can be used as educational materials for each member company.
The Information Review Study Working Group will encourage self-study through plan, development and management of various workshops and work to obtain a good reputation that the activities are attractive.

(2) Holding of seminars and training sessions
The Study Group will hold the following annual regular events to encourage member companies to acquire and broaden their knowledge.
・ A seminar on consumer drug consulting (scheduled in July)
・ An inquiry response skill up training (scheduled in October)
・ Site tour (scheduled in November)

(3) Holding of study workshops to acquire a wide range of knowledge
The Study Group will hold timely study workshops on subjects that are in high demand among member companies and work to obtain the various knowledge.

(4) Cooperation with related organizations
The Study Group will examine to collaborate with the related organizations regarding the corresponding to the common issues (such as a corresponding to customers).

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8. Pharmacovigilance Study Group
Established on May 24, 1963
 

The Pharmacovigilance Study Group participates in discussion sessions and projects organized by the government, FPMAJ and other organizations to collect latest information on safety measures for pharmaceutical products. It also supports member companies’ safety activities, by providing feedback and distributing information, such as notifications issued by the government, in a timely and appropriate manner. The Study Group exchanges and discusses opinions on new problems related to drug safety measures mainly through its standing committee. Based on the results of these activities, it will make proposals to the government, FPMAJ and other related organizations. It also plans and conducts workshops and training sessions as part of educational activities.

The Intelligence Task Force under the Study Group also provides educational programs designed for persons in charge of product safety to improve their skills to evaluate side effects of pharmaceutical products, and provide support to member companies so that they can swiftly take appropriate safety measures after pharmaceutical products are distributed in the market.

In FY2020, the Study Group will focus on the following activities:
(1) Activities related to new post-marketing safety management operating procedures
The Study Group will work to collect the information in a timely manner from the government and FPMAJ regarding the revised PMD Act promulgated in December 2019 and new movements of pharmacovigilance, support safety measures of member companies regarding the post-marketing safety management operating procedures by feeding the information back to member companies, and make proposals to FPMAJ, etc. if necessary.
The Study Group will also work to promote further use of the safety measure consultation at the Kansai Branch of PMDA.

(2) Activities related to compliance (safety) by marketing authorization holders
The Study Group will support member companies by collecting and providing information on-site inspections regarding GVP conducted by local governments and compliance inspections regarding GPSP by PMDA, and other related information in a timely manner so that they can smoothly comply with regulatory requirements. A standing member of the Study Group will participate in the Drug Standard Evaluation Task Force under the Pharmaceutical Regulatory Council of the Osaka Prefectural Government and offer opinions. The standing member will provide feedback to member companies to ensure that they know necessary information.

(3) Activities related to the drug information service system
A standing member of the Study Group will participate in the FPMAJ information service system project and offer opinions regarding the PMDA’s website on which information on drugs and medical equipment is provided. The standing member will provide feedback to member companies to ensure that they know necessary information.

(4) Activities related to measures to prevent medical accidents (FPMAJ’s Safe Drug Use Review Task Force)
A standing member of the Study Group will participate in the FPMAJ’s Safe Drug Use Review Task Force and provide feedback to member companies so that they can ensure safe use of their drugs and properly provide safe use information to prevent medical accidents.

(5) Enlightenment on drug safety measures
The Study Group will plan and hold seminars on drug safety by external lecturers. The chairman and the vice chairman of the Study Group will lecture at the pharmaceutical regulatory affairs workshops and the General Marketing Manager study course. Standing members will plan and hold “lectures/topic presentation in the Intelligence Task Force.” Through these activities, the Study Group will enhance the awareness of the importance of drug safety measures.

In particular, the Intelligence Task Force will support member companies in improving the abilities of their employees to evaluate safety management information and making proper actions such as generation and submission of reports in the appropriate format to the government through case studies of serious adverse reactions, research and measures reports. By using the published pharmaceutical product RMPs, the Task Force will also examine the components of these RMPs and the evidence of safety specification items, and provide support to member companies to deepen their understanding of RMPs. The Study Group will work to improve the response capability of the member companies through providing topics related to pharmacovigilance from the standing members and sharing of understanding of issues in safety management operations and related notifications, etc.


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9. MR Education and Training Study Group
Established on March 3, 1980
 

The Medical Representatives (MR) Education and Training Study Group will support member companies in conducting effective MR education and training, by improving and strengthening its education and training programs, aiming to improve the quality of introductory education and continuing education of MR.
The Study Group will also participate in councils organized by the MR Education & Accreditation Center of Japan and strive to reflect opinions and requests of member companies in the activities of these councils.

In FY2020, the Study Group will focus on the following activities:
(1) Activities to support MR continuing education
The MR Education & Accreditation Center of Japan requires that basic education should be conducted for more than 40 hours each year for continuing education. In reality, the education and training departments of member companies have to use considerable time and labor to implement these training sessions.

Under these circumstances, the Study Group will provide a one-year curriculum designed for trainers in charge of MR education to support member companies in providing continuing education. In providing this program, subjects designated as important in the MR text books will be included in the curriculum. Lecturers will be selected from experts in the field covered in each lecture session from among the member companies of the Study Group. For certain subjects, external lecturers may be invited to provide the latest information to member companies.

(2) Activities to support examinees who take the MR certification exam
For the 27th MR certification examination scheduled in December 2020, the Study Group will offer a training course in November to assist examinees who will take the examination so that they can pass the examination. It will also provide educational materials and information useful for examinees who will take the examination.

(3) Implementation of study sessions and site tours related to MR education and training
The Study Group regularly holds general meetings. At the general meetings, study sessions and site tours on effective MR education will be provided to further improve the quality of trainers in charge of MR education and promote information sharing related to MR education.

(4) Activities related to MR Education & Accreditation Center of Japan
A representative from the Study Group will participate in the regular meetings of the Education and Training Committee and Committee on Educational Training System Reform held by MR Education & Accreditation Center of Japan to collect appropriate information and express opinions as necessary, by which it supports MR education activities of member companies.

The representative will also participate in other events hosted by the MR Education & Accreditation Center of Japan to obtain information to share with member companies, including the Conference for Education and Training Responsible Persons, and the Education/Training Administrator Certification Renewal Workshop, Center Meetings, and related seminars.


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10. Clinical Trial Promotion Study Group
Established on April 1, 2000

The Clinical Trial Promotion Study Group collects problem cases related to clinical trials from member companies and hold active opinion exchange meetings to find concrete solutions for these problems that match the actual conditions of clinical trials. The results of these activities are communicated to member companies. The results obtained through these opinion exchange meetings that can be shared among member companies are also compiled into publications. The Study Group also offers opinions to regulatory authorities as necessary.

In FY2020, the Study Group will focus on the following activities:
(1) Promotion of working group activity
The Clinical Trial Task Force, the sub-sector of the Study Group, has formed working groups that examine various subjects related to clinical trials. The Task Force consists of 5 working groups, and will work diligently to compile the result of each working group activities by the end of FY 2021. Through these activities of the working groups, it will support for effective and efficient clinical trial activities of the member companies.

The working groups under the Task Force will examine the following subjects:
〔Clinical Trial Task Force〕
The fist working group: Response to ICH-E6(R2) and Guideline for GCP
The second working group: Awareness raising for ICH-E8(R1)
The third working group: Response to Clinical Trials Act
The fourth working group: Create educational tools for CRA and CRA leaders
The fifth working group: Review of implement plans based on the revised Guidelines for Bioequivalence Studies of Generic Drugs, templates for Clinical Trial Summary Report, etc. and consideration of QMS focused on bioequivalence studies

(2) Hold a general meeting
The Study Group will hold a general meeting in May 2020 and work to promote smooth working group activities by selecting a chairperson of each working group and determining future directions, etc. prior to the start of each working group activities. Apart from these activities, the Study Group will hold a plenary meeting of the Task force regularly before the working group activities, and promote information sharing among working groups and exchange of information among member companies.

(3) Support for the activities of KPIA
The Study Group will give a lecturer on a subject related to GCP at the pharmaceutical regulatory affairs workshop that KPIA holds as a part of its annual educational curriculum so that we can strive to improve the knowledge of practitioners in member companies.

(4) Cooperation with related parties
The Study Group will cooperate with MHLW, PMDA, the Osaka Prefectural Government, the Clinical Trial Network Osaka, the Center for Clinical Trial (Japan Medical Association), the Japan Society of Quality Assurance, the Japan Pharmacists Education Center and other related parties to collect information necessary for member companies to conduct proper clinical trials.
It will also promote cooperation with other related parties, including publicity of their events at their request.

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Acronym
- FPMAJ: Federation of Pharmaceutical Manufacturers’ Association
- GCP: Good Clinical Practice
- GDP: Good Distribution Practice
- GMP: Good manufacturing Practice
- GQP: Good Quality Practice
- IT: Information Technology
- JETRO: Japan External Trade Organization
- JPMA: Japan Pharmaceutical Manufacturers Association
- JPO : Japan Patent Office
- JSMI: Japan Self-Medication Industry
- KPIA: Kansai Pharmaceutical Industries Association
- MHLW: Ministry of Health, Labor and Welfare
- MR: Medical Representative
- MRA: Japan-EU Mutual Recognition Agreement
- OTC drug: Over-The-Counter drug
- PIC/S: Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
- PMAT: Pharmaceutical Manufacturers’ Association of Tokyo
- PMD Act: Act on Securing Quality, Efficacy and Safety of Pharmaceutical Products and Medical Devices (Pharmaceutical and Medical Devices Act)
- PMDA: Pharmaceuticals and Medical Devices Agency
- PMRJ: Pharmaceutical and Medical Device Regulatory Science Society of Japan
- PRAISE-NET: Pharmaceutical Regulatory Affairs Information Service - Network
- R & D: Research and Development
- RMP: Risk Management Plan

 

 

 

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