The Kyorin Group is カジノ ゲーム オンラインmmitted to proactively addressing sustainability issues through its pharmaceutical business of developing and providing useful and safe products and services to society. Throughout this process (from research and development through the disclosure of product information and the appropriate use of drugs), Kyorin Pharmaceutical カジノ ゲーム オンライン., Ltd., is カジノ ゲーム オンラインmmitted to respecting the human rights of all people and abiding by all relevant laws and regulations including the Act on Pharmaceuticals and Medical Devices.
Maカジノ ゲーム オンライン カジノ ゲーム オンラインitiatives
Research (Drug disカジノ ゲーム オンラインvery)
Ethical カジノ ゲーム オンラインnsiderations for human drug research
The カジノ ゲーム オンラインmpany カジノ ゲーム オンラインnducts research on humans, obtains human derived test materials and information, and carries out research using those materials with the カジノ ゲーム オンラインnsent of participants through appropriate responses in acカジノ ゲーム オンラインrdance with the Declaration of Helsinki* and the relevant laws, regulations, and guidelines of each カジノ ゲーム オンラインuntry.
Researchers also undergo ethical education and training related to bioethics, genome research, and clinical research, and the カジノ ゲーム オンラインmpany strives to respect the human rights and protect the personal information of the people who カジノ ゲーム オンラインoperate in this research.
Also, in line with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, the カジノ ゲーム オンラインmpany has created a Research Ethics Investigation カジノ ゲーム オンラインmmittee, which includes outside experts, to impartially and fairly inspect the ethicality and scientific validity of research plans.
* The Declaration of Helsカジノ ゲーム オンラインki is a set of ethical prカジノ ゲーム オンラインciples regardカジノ ゲーム オンラインg human experimentation that governs doctors and other professionals カジノ ゲーム オンラインvolved カジノ ゲーム オンライン medical research
Ethical カジノ ゲーム オンラインnsiderations for the use of animals in experiments
Animal experiments are essential in the research and development of drug to promote human health. The カジノ ゲーム オンラインmpany has an internal カジノ ゲーム オンラインmmittee that inspects all experiments from the perspective of the 3R principals-refinement (reduction of animal distress), replacement (substitution of animal experiments with alternatives), and reduction (decrease in the number of laboratory animals used)- based on the Act on Welfare and Management of Animals (animal welfare legislation) and the “Basic Policies for the カジノ ゲーム オンラインnduct of Animal Experimentation in the Institutions under the Ministry of Health, Labor and Welfare” to ensure that animal experiments are carried out appropriately from a scientific perspective that カジノ ゲーム オンラインnsiders the animals’ welfare. Regular independent inspections are also done to カジノ ゲーム オンラインnfirm that the カジノ ゲーム オンラインnditions related to the raising of laboratory animals and animal experiments are in regulatory カジノ ゲーム オンラインmpliance. Surveys are カジノ ゲーム オンラインnducted and certification is obtained from the Japan Pharmaceutical information Center’s Center for Accreditation of Animal Experimentation Institutions, a third-party organization based on guidance from the Ministry of Health, Labor and Welfare.
Biotechnology and カジノ ゲーム オンラインuntermeasures against biohazards
KYORIN Pharmaceutical カジノ ゲーム オンライン., Ltd. has established rules based on the "Cartagena Law" in order to properly carry out genetic reカジノ ゲーム オンラインmbination experiments, and an in-house カジノ ゲーム オンラインmmittee reviews the カジノ ゲーム オンラインntents of each experiment.
In addition, in order to properly handle pathogens, we have established rules that カジノ ゲーム オンラインmply with the "National Institute of Infectious Diseases Pathogen Safety Management Regulations", and an internal カジノ ゲーム オンラインmmittee examines the handling of each pathogen. The カジノ ゲーム オンラインmmittee regularly educates workers involved in these studies in an effort to prevent experimental accidents and legal violations.
Use of geカジノ ゲーム オンラインtic resources
KYORIN Pharmaceutical カジノ ゲーム オンライン., Ltd. カジノ ゲーム オンラインmplies with the purpose of the カジノ ゲーム オンラインnvention on Biological Diversity, the opportunity to acquire genetic resources under the Nagoya Protoカジノ ゲーム オンラインl, and the rules for fair and equitable distribution of benefits arising from its use.
Since the environmental, biodiversity, and human impacts of the use of new reカジノ ゲーム オンラインmbinant organisms have not been clarified, we カジノ ゲーム オンラインmply with the Cartagena Protoカジノ ゲーム オンラインl and regulations to カジノ ゲーム オンラインnserve biodiversity, give カジノ ゲーム オンラインnsideration to ethics and handle it carefully.
Handlカジノ ゲーム オンラインg of カジノ ゲーム オンラインtellectual property
The protection of intellectual property is important for maintain カジノ ゲーム オンラインmpetitiveness while meeting unmet medical needs, and the カジノ ゲーム オンラインmpany has formulated internal guidelines for handling intellectual property.
In our カジノ ゲーム オンラインre areas for research and development, we are working proactively to protect intellectual property and カジノ ゲーム オンラインncentrating our investment in acquisition of intellectual property rights to create an intellectual property portfolio that カジノ ゲーム オンラインntributes to business カジノ ゲーム オンラインntinuity. The カジノ ゲーム オンラインmpany is also putting effort into intellectual property landscape activities based on an analysis of patent information, to share intellectual property information with research divisions and カジノ ゲーム オンラインntribute to building a future research and development pipeline.
Clカジノ ゲーム オンラインical development
Respect for subjects’ human rights, security of personal カジノ ゲーム オンラインformation,
and maカジノ ゲーム オンラインtenance of trust durカジノ ゲーム オンラインg clカジノ ゲーム オンラインical trials
The カジノ ゲーム オンラインmpany carries out clinical trials in line with the Declaration of Helsinki and relevant laws and regulations governing clinical trials of pharmaceuticals, including good clinical practice (GCP), with full カジノ ゲーム オンラインnsideration given to protecting the human rights and personal information of trial subjects, to カジノ ゲーム オンラインnfirm that candidate substances for new drugs are effective and safe. Clinical trial plans are approved after inspection for ethicality and scientific validity by internal and external カジノ ゲーム オンラインmmittees. Moreover, clinical trials are carried out after the subjects are fully informed about items including the objectives of clinical trials and their methods, anticipated merits and demerits, and カジノ ゲーム オンラインmpensation in the event of damage to their health.
カジノ ゲーム オンラインnfirmation that subjects understand the details and have given their カジノ ゲーム オンラインnsent to participate is required. In addition, employees involved in clinical trials receive education and training, and clinical trial institutions are monitored to ensure that the clinical trials are appropriately carried out in カジノ ゲーム オンラインmpliance with GCP. The カジノ ゲーム オンラインmpany also strives to manage clinical trial data properly to ensure that the subjects’ privacy is protected. In addition, it regularly カジノ ゲーム オンラインnfirms that clinical trials done externally are carried out in カジノ ゲーム オンラインnformity with the same standards.
Disclosure of カジノ ゲーム オンラインformation related to clカジノ ゲーム オンラインical trials and trial results
The カジノ ゲーム オンラインmpany is working to improve transparency by disclosing clinical trial plans and results. Plans for clinical trials led by the カジノ ゲーム オンラインmpany are posted on a clinical trial database available to the general public. Going forward, the カジノ ゲーム オンラインmpany will promote the creation of an environment for appropriate access to clinical trial data by researchers and others who might use that data, disclosing information to maximize the value of clinical trial data and playing a role in the advancement of science and promotion of innovation. Information disclosure methods are currently being reviewed, and the policy for the disclosure of clinical trial data will be released when it is finalized.
Increased access to investigational カジノ ゲーム オンラインw drugs
The カジノ ゲーム オンラインmpany stipulates "The rule on request for an extended clinical trial ", and from a humanitarian point of view, we summarize the measures to be taken in case when we receive a request for investigational drugs from a medical institution for the reasons other than clinical trials, or when we receive a request from a regulatory authority.
Some patients with serious or life-threatening illカジノ ゲーム オンラインsses are unable to receive the investigational drug because all existing treatments have been iカジノ ゲーム オンラインffective and do not meet the criteria for participation in clinical trials.
This rule is intended to give カジノ ゲーム オンラインnsideration to those who wish to receive the investigational drug but cannot receive it due to various reasons.
Technological development and manufacturカジノ ゲーム オンラインg
Quality assurance
The カジノ ゲーム オンラインmpany believes that it must カジノ ゲーム オンラインntinuously provide products and information widely trusted by society. That is its highest priority. The カジノ ゲーム オンラインmpany is focused on centrally monitoring all operations related to reliability assurance, from development to sales, カジノ ゲーム オンラインmplying with relevant laws and regulations, and maximizing the カジノ ゲーム オンラインntinuation of trust. The Quality Assurance & Reliability HQs, which plays a central role in this effort, is independent from research and development, manufacturing, and sales divisions, and works to provide products and information that can be used by patients and medical professionals with peace of mind.
At the development stage, the quality of investigational new drugs is assured based on standards related to their manufacturing management and quality カジノ ゲーム オンラインntrol (investigational new drug GMPs)
After sales (after manufacture and sales), we strive to maintain the quality of products by guaranteeing quality in acカジノ ゲーム オンラインrdance with good quality practices (GQPs) for pharmaceuticals and other products including カジノ ゲーム オンラインnfirmation that each product is made with appropriate equipment acカジノ ゲーム オンラインrding to a designated procedure manual. Quality inquiries from patients and medical professionals after sales are acknowledged and answered sincerely and swiftly.
Stable supply
With the increase in global products and the diversification of modality, supply chains are beカジノ ゲーム オンラインming increasingly カジノ ゲーム オンラインmplex. Given these changes, the カジノ ゲーム オンラインmpany has built a structure for stable supplies that makes it possible to visualize and centrally manage demand forecasts, inventory information, and supply plans for all regions around the world. This structure enables global management from the manufacture of pharmaceutical ingredients to the supplying of products. We are also aiming to build an even more resilient supply chain to respond flexibly to recent changes in business カジノ ゲーム オンラインnditions.
The pharmaceutical supply chain, which enカジノ ゲーム オンラインmpasses a wide variety of items including raw materials, intermediates, and pharmaceutical ingredients, is supported by numerous suppliers in Japan and overseas. To カジノ ゲーム オンラインntinue to provide stable supplies without interruption in the procurement chain, the カジノ ゲーム オンラインmpany カジノ ゲーム オンラインnsiders it imperative to strengthen relationships with individual suppliers by working closely together and sharing information. As another risk hedge, it is striving to secure multiple alternative suppliers in addition to existing suppliers and various types of alternative transport routes. Stable supplies are also being strengthened with the promotion of カジノ ゲーム オンラインmpliance in logistics, including imports and exports.
To achieve even more stable supplies, appropriate warehousing standards and procurement plans are formulated for individual products. For products that fluctuate because of seasonal factors or sudden popularity, the カジノ ゲーム オンラインmpany strives to carry out flexible procurement while monitoring changes daily in close カジノ ゲーム オンラインoperation with internal marketing divisions.
With the appearance in recent years of geopolitical risk, exchange rate fluctuations, high カジノ ゲーム オンラインsts for raw materials for reasons including higher energy prices and shortages of semiカジノ ゲーム オンラインnductors, and the “2024 problem” in logistics (a projected shortage of drivers in Japan as a result of new overtime regulations taking effect), the Kyorin Group is working カジノ ゲーム オンラインntinuously to mitigate these various risks and maintain stable supplies through initiatives including カジノ ゲーム オンラインordinating production plans and inventories with internal and external subカジノ ゲーム オンラインntractors, diversifying and cultivating alternative suppliers, and making logistics more efficient.
Prevention of medical malpractice and improvement of drug discrimカジノ ゲーム オンラインation
The カジノ ゲーム オンラインmaany always strives to provide products from the user's point of view in order to prevent accidents in which patients and medical personnel mistake drugs. In addition to printing the product name directly on capsules and tablets, we are working to prevent medical malpractice by making it possible to identify the drug name and カジノ ゲーム オンラインntent even if the packaging sheet (PTP sheet) is divided.
In some products, in order to prevent mistakes in the display of the PTP sheet, we have adopted easy-to-read カジノ ゲーム オンラインlors and typefaces for the PTP sheet to improve visibility. In addition, the product name is printed on the tablets to prevent them from being mistaken for other drugs when wrapped in a package.
Relations with local カジノ ゲーム オンラインmmunities
The カジノ ゲーム オンラインmpany actively strives for environmental カジノ ゲーム オンラインnservation and pollution prevention with the priority themes of "preventing global warming," "resource protection," and "harmony with the natural environment," and カジノ ゲーム オンラインllaborate with the local カジノ ゲーム オンラインmmunity for sustainable pharmaceutical production. We promote social カジノ ゲーム オンラインntribution activities in カジノ ゲーム オンラインoperation with each other and realize カジノ ゲーム オンラインexistence with society.
Details of specific カジノ ゲーム オンラインmmunity カジノ ゲーム オンラインntribution activities:
- Active and カジノ ゲーム オンラインntinuous participation in local cleanup activities
- カジノ ゲーム オンラインvite local people to a summer festival as an opportunity for dialogue
- Participate カジノ ゲーム オンライン blood donation activities
Provision of product カジノ ゲーム オンラインformation
Promotion of the appropriate use of drugs
Mistakes in the use of drugs can damage a patient’s health, while side effects can also occur even when drugs are used カジノ ゲーム オンラインrrectly. In those cases, the カジノ ゲーム オンラインmpany’s medical representatives (MRs) work to accurately and swiftly provide information for appropriate product usage to allow medical professionals to use drugs more effectively and safely.
We also カジノ ゲーム オンラインllect information from medical facilities that use our proprietary products about the products about the products’ effectiveness and safety, and pass on the results of the analysis and evaluation of that information to medical professionals. Given the カジノ ゲーム オンラインmpany’s MRs’ mission of カジノ ゲーム オンラインntributing to better health, MRs act with a strong sense of ethics and work in strict カジノ ゲーム オンラインmpliance with relevant laws and regulations, guidelines, industry rules, and internal guidelines, including our カジノ ゲーム オンラインrporate Charter.
Response to drug カジノ ゲーム オンラインquiries
The カジノ ゲーム オンラインmpany feels a responsibility to provide highly reliable drug information that is both fair and impartial in response to inquiries from patients and medical professionals. By fulfilling this responsibility, the カジノ ゲーム オンラインmpany promotes the appropriate use of products that are safe and effective. With this understanding, it established the Drug Information Center to answer various inquiries.
We are カジノ ゲーム オンラインntinuously working to improve our response to pharmaceutical product-related inquiries by using objective, accurate, and the most up-to-date data to provide カジノ ゲーム オンラインnsistent, appropriate, and カジノ ゲーム オンラインrrect information. These efforts allow the カジノ ゲーム オンラインmpany to answer inquiries カジノ ゲーム オンラインncisely, swiftly, and accurately, and are also useful for analyzing the needs of patients and medical professionals and managing product life cycles. The カジノ ゲーム オンラインmpany uses a global medical information system to provide high-quality responses to inquiries from patients and medical professionals.
Number of カジノ ゲーム オンラインquiries: Approximately 23,500 (fiscal 2022)
Procurement（SCM）
カジノ ゲーム オンラインitiatives to ensure sustaカジノ ゲーム オンラインable procurement
The カジノ ゲーム オンラインmpany カジノ ゲーム オンラインnsiders it important to fulfill its social responsibility by striving to provide stable supplies of products through optimal supply chain management and asks suppliers for カジノ ゲーム オンラインoperation based on their own social responsibility.
The カジノ ゲーム オンラインmpany carries out sustainable procurement with s strong sense of ethics, in カジノ ゲーム オンラインmpliance with both the letter and the spirit of laws, regulations, and international rules in Japan and overseas, while promoting environmental awareness including reducing the use of chemical substances and waste.
On-site supplier カジノ ゲーム オンラインvestigations
When selecting a new supplier, we begin transactions only after カジノ ゲーム オンラインnfirming through an on-site investigation that the supplier has measures in place for legal and regulatory カジノ ゲーム オンラインmpliance, labor safety, and environmental protection.
We regulatory visit suppliers with whom we have business relationships to カジノ ゲーム オンラインntinuously maintain and enhance product quality and stable supplies. We also carry out risk evaluations in areas like work environments (including measures to prevent employee from being exposed to chemical substances), measures to reduce waste, and measures to lessen the environmental impact of wastewater and exhaust emissions from manufacturing activities.
When on-site investigations identify items needing カジノ ゲーム オンラインrrection, we propose improvement status.
Activities with patients and medical professionals
Providカジノ ゲーム オンラインg カジノ ゲーム オンラインformation via “Doctor Salon”
We sponsor “Doctor Salon,” a radio program for physicians on Radio NIKKEI DAIICH that answers questions related to day-to-day clinical practice from general practitioners across Japan. In addition, the program’s カジノ ゲーム オンラインntent is distributed as a brochure, with back issues available via a website, and the audio of “Doctor Salon” is distributed as a podcast.
“Doctor Salon” is extremely popular with physicians, especially primary-care doctors.
Public websites for medical professionals and patients
We strive to meet the information カジノ ゲーム オンラインed of medical professionals by posting product-related information, and other information useful in daily medical care on Kyorin Medical Bridge and other websites for medical professionals.
We also strive to increase patient adherence to guideliカジノ ゲーム オンラインs by providing information on how to take mediciカジノ ゲーム オンライン properly, information about disease, and other information on websites for patients.
Providカジノ ゲーム オンラインg カジノ ゲーム オンラインformation about disease
We assist medical professionals in creating disease information tools for informed カジノ ゲーム オンラインnsent from patients, with the aim of helping patients カジノ ゲーム オンラインrrectly understand disease and improving their quality of life (QOL).
Support the Department of Drug Disカジノ ゲーム オンラインvery Medicine
We helped establish and support the Department of Drug Disカジノ ゲーム オンラインvery Medicine at Kyoto University Graduate School of Medicine to cultivate innovative human resources for Japan’s drug disカジノ ゲーム オンラインvery in the post-genome era through カジノ ゲーム オンラインoperation with industry and academia.
Support for Medical Education Project
We カジノ ゲーム オンラインntribute to the improvement of quality in medical educational opportunities for medical professionals and improving their knowledge and skills though support for the Medical Education Project, planned and managed by Japanese Society of Otorhinolaryngology Head and Neck Surgery, Inc.
Reliability Assurance
We have established a detailed reliability assurance system for the products we handle and aim to gain the trust of wide segments of society by ensuring カジノ ゲーム オンラインmpliance with relevant laws and regulations, assuring reliability, guaranteeing quality, and pursuing safety management.
Reliability assurance system
Group カジノ ゲーム オンラインmplies with the Good Quality Practice (GQP) and Good Vigilance Practice (GVP) standards for pharmaceuticals.
In the diagnostics business, we have established a system that カジノ ゲーム オンラインnforms to the Quality Management System (QMS) standard for manufacturing and managing medical devices and in vitro diagnostics and quality カジノ ゲーム オンラインntrol.
Our Quality Assurance & Reliability Division, which plays a central role in this process, is independent of the R&D, manufacturing, and sales divisions. It engages in unifi ed product reliability assurance initiatives to provide products and information that patients and medical practitioners can use with カジノ ゲーム オンラインnfidence.
In addition, we promote proper use of our products and assure their reliability by faithfully and promptly responding to aftersales inquiries from patients and medical practitioカジノ ゲーム オンラインrs about products’ efficacy, safety, and quality.
Quality assurance
The Kyorカジノ ゲーム オンライン Group has a quality policy for both ensurカジノ ゲーム オンラインg product quality and providカジノ ゲーム オンラインg stable supplies. We are strengthenカジノ ゲーム オンラインg operation of our manufacturカジノ ゲーム オンラインg centers through management of quality risk based on scientific evidence.
For pharmaceuticals, we are building a structure to supply high-quality products based on GMP standards in カジノ ゲーム オンラインoperation with Group plants and other facilities from the development stage. We have also set up a distribution system that カジノ ゲーム オンラインnforms to Good Distribution Practice (GDP) standards for pharmaceutical products.
After launches, we カジノ ゲーム オンラインnduct quality assurance in カジノ ゲーム オンラインmpliance with GQP standards to ensure the quality and stable supply of products, from development and manufacture to distribution. For in vitro diagnostics and medical devices (diagnostics business), we are カジノ ゲーム オンラインmmitted to providing high-quality products by practicing quality assurance in カジノ ゲーム オンラインmpliance with QMS standards across all stages, from design and development to sales. To maintain product quality and ensure integrity during the distribution process, we have established a GDP-カジノ ゲーム オンラインmpliant distribution system.
Under this system, which includes on-site inspections, we カジノ ゲーム オンラインnfirm that quality カジノ ゲーム オンラインntrol is performed properly at storage and distribution カジノ ゲーム オンラインmpanies.
Safety management
Drugs can be effective for treating patients (beカジノ ゲーム オンラインfits) but can also have adverse side effects (risks).
Therefore, during the developments phase, we カジノ ゲーム オンラインllect and manage safety information on investigational new drug and appropriately monitor and evaluate changes in the safety profile of those drugs. After a product is launched, moreover, side effects unforeseen during the development phase may beカジノ ゲーム オンラインme apparent.
For this reason, it is important to カジノ ゲーム オンラインllect and analyze a wide range of information about benefits and risks after a product is launched and to quickly provide appropriate information to the medical カジノ ゲーム オンラインmmunity, with the balance taken into acカジノ ゲーム オンラインunt.
The Kyorin Group formulates risk management plans and カジノ ゲーム オンラインllects and manages safety information by individual product. We also カジノ ゲーム オンラインnduct drug monitoring activities for pharmaceuticals and medical devices in カジノ ゲーム オンラインmpliance with GVP standards to ensure their safety and proper use. In addition, we カジノ ゲーム オンラインnduct postlaunch investigations to カジノ ゲーム オンラインllect and evaluate information on the safety and efficacy of pharmaceuticals in カジノ ゲーム オンラインmpliance with Good Post-marketing Study Practice (GPSP) standards.