Sumitomo Dainippon Pharma Annual Report 2017

Activities in Corporate Regulatory Compliance & Quality AssuranceActivities in Corporate Regulatory Compliance & Quality AssuranceSumitomo Dainippon Pharma’s Medical Science framework, composed of Medical Information and Medical Affairs Departments, has been newly established in order to strengthen our capability to accurately grasp the unmet needs of healthcare professionals and to execute medical communication and provision of medical information to address those needs in a scientifically objective, unbiased, reliable, and evidence-based manner. The Medical Information and Medical Affairs Departments are both corporate departments reporting to the same executive officer and carry out their activities with closer collaboration as a Medical Science framework. Medical Information supports MRs’ provision of safety and quality information and ensures the provision of accurate promotional information by reviewing promotional materials and slides presented at lecture meetings.Medical Affairs, in order to have the efficacy and safety of our pharmaceuticals meet the needs of patients and healthcare professionals, will continue to communicate the true value of our products by explaining their medical information from a scientific standpoint. Furthermore, we assigned a medical science liaison (MSL) in the therapeutic field of neurology working to grasp unmet medical needs through scientific communication with healthcare professionals, which will lead to new evidence generation, additional dosage formulation, and additional indications. An MSL also serves as a contact person for clinical research and provides medical information with informed scientific knowledge in response to requests from healthcare professionals.We are contributing to the healthy lives of patients and their Medical communication and provision of medical information based on robust scientific evidence in order to address current unmet medical needsAn Exclusive Commitment to Handling Inquiries:Pharmaceuticals Information CenterCSRCSRSumitomo Dainippon Pharma established the Pharmaceuticals Information Center as a customer support contact center for inquiries about our products from patients and their families, in addition to healthcare professionals. To contribute to the health of patients, we will continue swiftly and politely providing accurate information on the proper use of pharmaceuticals.The Pharmaceuticals Information Center is integrated with the Medical Information Department. Consequently, by carrying out inquiry responses, knowledge sharing, FAQ updates, and so on within the same department, we expect to more promptly and efficiently provide information with a robust scientific background. We also encourage appropriate internal feedback on content learned from external requests, which leads to further improvements of our products and materials.families by leveraging our new Medical Science framework to enhance activities for providing high quality medical information and fulfill unmet medical needs that take into account the needs of healthcare professionals.Drug formulation Safety Clinical usageRequests for materials Law / Healthcare systems / PrescriptionsDiscontinuation / Distribution Other30.8%17.4%17.2%15.7%7.7%2.8%8.4%each pharmaceutical can be utilized more safely. For example, when new adverse reactions are added to precautions on package inserts, “Notice of Revisions to Precautions” are promptly provided to healthcare professionals by MRs and via our website, and we communicate what kind of adverse reactions should be taken into consideration in the use of pharmaceuticals. Furthermore, the tablet terminals carried by MRs are equipped with information for explaining the “Notice of Revisions to Precautions” in more detail, making it possible for them to communicate to healthcare professionals accurately.We also provide documents such as “Kusuri-no-shiori” and “Instructional Leaflets” which are used by healthcare professionals in explaining to patients about dosing schedules, precautions for use, possible adverse reactions, and so on. Illustrations are used in the “Instructional Leaflet” so that the elderly and children can easily understand them.Sumitomo Dainippon Pharma promptly and accurately provides healthcare professionals with updated information on the proper use of pharmaceuticals in order to ensure that the benefits of Prompt and Accurate Provision of Information toMedical Institutionspromptly provide necessary information to physicians and pharmacists for ensuring proper usage of the products.In Japan, we are working strenuously to ensure the safe and proper use of our pharmaceuticals through pharmacovigilance activities in compliance with the Pharmaceuticals, Medical devices and Other Therapeutic Products Act and Good Vigilance Practice ordinance (GVP)*2.Moreover, we have a system that helps us to manage and evaluate all safety information on products developed and marketed in multiple countries and to take measures required for securing the safety of our pharmaceuticals.*2 Good Vigilance Practice: A standard for managing the post-marketing safety of pharmaceuticals, quasi-pharmaceuticals, cosmetics and medical devices (post-marketing safety management standard).Inquiries during FY2016 (Approximately 48,500)32Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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