Responsible Research & Development
Compliance to Research Ethics
SK bioscience recognizes the need for ethical compliance in the process of research and development of products. To ensure research integrity that follows the core values including objectivity, integrity, openness, and responsibility and fairness throughout the entire research process, we document the planning, conduct, reporting, and evaluation of research, and substantiate research results based on accurate data.
When handling biological materials, we maintain a safe environment by establishing a biosafety committee within our R&D Center to protect the public’s health from potential risk factors.
Meanwhile, SK bioscience has been designated and operated as a Good Clinical Laboratory Practice(GCLP) facility by the Ministry of Food and Drug Safety pursuant to Article 34-2, Paragraph1, Item 2 of the Pharmaceutical Affairs Act and Article 35 of the Rules on the Safety of Drugs. As a result, all our research activities are conducted in strict compliance with Good Laboratory Practice(GLP), Good Clinical Laboratory Practice(GCLP), and domestic and international regulations. Furthermore, to maintain our GCLP status, we undergo regular examinations by the Ministry of Food and Drug Safety to assess overall performance, including the management of human-derived materials(samples).
In addition, as a part of the preclinical and clinical research, we define and adhere to relevant guidelines in our research to enhance the ethics and reliability of animal testing. Even when experiments are conducted through external Contract Research Organizations(CRO), we have established a management system that monitors and supervises them, ensuring they operate under the same procedures and standards.
Research & Development Quality Assurance
SK bioscience is committed to ensuring objectivity, honesty, openness, and fairness throughout the entire research and development process, including planning, proposing, conducting, reporting, and evaluating studies. To achieve this, the Company is strengthening research data management.
Research integrity is a critical factor in providing reliable data not only for our own products and projects but also for the C(D)MO business. While we strive to secure research integrity, we also recognize the need for digital innovation through DT/IT technology and adopt it in practice to efficiently manage research output. In 2023, SK bioscience's Bio Research Division implemented an Electronic Document Management System (eDMS) to digitize documents generated during research and development, moving towards a Paperless Lab. In 2024, the Company plans to introduce an Electronic Laboratory Notebook (ELN) to enhance research data management, assetize research know-how, and ensure the reliability of the research and development system and data.
In 2025, alongside the relocation to the Songdo Global R&PD Center, SK bioscience plans to introduce and advance a Scientific Data Management System (SDMS). The Company also aims to enhance its Project Management System (PMS) to enable systematic management of research projects and facilitate efficient and transparent C(D)MO operations through electronic systems.
Biosafety
SK bioscience has established the Institutional Biosafety Committee(IBC) at the R&D Center to prevent accidents that may occur while handling pathogenic organisms and to promptly take appropriate measures or provide medical treatment in the event of a biosafety incident. The committee is composed of external members who have no conflict of interest with the Company, ensuring objectivity. It discusses biosafety comprehensively, considering various aspects such as science, law, safety, and corporate strategy.
The IBC is responsible for reviewing and approving risk assessments for experiments that require biosafety management, such as genetic recombination experiments, and monitoring the safety management status of Living Modified Organisms(LMOs). The committee approves matters related to biosafety education, training, and health management, as well as the establishment and revision of biosafety management regulations. Through these responsibilities, the committee thoroughly reviews all aspects of research ethics and makes rational decisions. Additionally, it has established an operating manual for biosafety and management procedures, designated personnel in charge of biosafety management and a manager to provide training to relevant employees.
- 생물안전 위원장
- 생물안전관리 책임자
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내부위원
- 법무관리자
- 시설안전관리자
- 간사위원 (생물안전관리자)
- 의료관리자
- 보건관리자
- 외부위원
Control of Clinical Sample under GCLP
SK bioscience manages clinical trial samples collected from clinical trial subjects upon the client’s request. We also ensure that human-derived materials such as blood, body fluids, and tissues are not used for any other unintended purposes. We record and manage all processes from receipt, storage, transportation, and disposal of samples collected in clinical trials in accordance with internal procedures. In addition, qualified personnel with specialized education and training manage human-derived samples, and in case of adverse events, we promptly report on the safety and rights of subjects following response procedures.
In 2023, SK bioscience became the first domestic clinical trial sample analysis institution to implement a Laboratory Information Management System (LIMS). This system automates manual processes, ensuring data integrity, accuracy, and consistency, thereby guaranteeing the quality and truthfulness of data.
Non-Clinical Safety Study Management
SK bioscience conducts animal tests from the preclinical stage to clinical trials, including tests for our COVID-19 vaccine. Additionally, to secure product approval and commercialization, safety and efficacy are confirmed through animal testing during the research and development phase. When evaluating external Contract Research Organizations (CROs) that conduct preclinical trials, SK bioscience operates a management system based on the 3R principles (Replacement, Reduction, Refinement) to ensure compliance with animal ethics and respect for the dignity of animal life. This system includes evaluating, monitoring, and supervising CROs.
Animal Testing Ethics Compliance
SK bioscience has established a management system to ensure ethical practices in animal testing and provide relevant training to raise the ethical awareness of those responsible for conducting the tests. Following the MFDS guidelines for the standard operation of Institutional Animal Care and Use Committee(IACUC), we founded the Animal Testing Ethics Committee for lab animal protection and ethical compliance, and have secured ethicality and reliability by adhering to laws related to animal testing.
The committee deliberates on the ethical and scientific validity of animal experiments through on-site visits and guides and supervises related education and training. Furthermore, during regular bi-annual IACUC meetings, we assess the processes of using and managing laboratory animals, offer necessary advice, review the implementation of SOPs and related laws, and address any shortcomings identified by the IACUC to enhance the management system.
Animal Testing Process
SK bioscience raises ethical awareness of animal testing by requiring those in charge of animal testing to complete statutory training on lab animal handling and ethics, while also encouraging their participation in periodic training sessions. In addition, we respect the dignity of animal life by conducting deliberations based on the 3R(Replacement, Reduction, Refinement) principle when reviewing animal test plans and prioritizing alternative methods to animal testing. Moreover, through PAM1), the IACUC monitors the animal testing process with the researcher to promote animal welfare and ensure the reliability and transparency of experimental results.
- 1)PAM : Post-Approval Monitoring
- 정기적인 실험 담당자 교육
- 3R 원칙 기반 심의 실시
- 동물실험 승인
- 실험 과정 모니터링 실시
Antimicrobial Resistance (AMR)
As a Company that develops, produces, and sells vaccines, SK bioscience recognizes the critical global public health risk posed by increasing antibiotic resistance. According to the World Health Organization (WHO), antibiotic resistance is among the top 10 global public health threats. Resistance diminishes the efficacy of antibiotics (including antibacterial, antiviral, and antifungal agents), leading to the spread of infections, severe diseases, disabilities, and increased mortality.
Moreover, antibiotic resistance is identified as a threat to global development. The primary cause of antibiotic resistance is the misuse and overuse of antibiotics in humans, animals, and plants. While this is a worldwide issue, it is particularly severe in underdeveloped countries with fragile healthcare infrastructures, causing significant economic burdens on patients.
Preventing disease infections through vaccination is one method to reduce antibiotic misuse. SK bioscience is committed to developing and marketing effective and safe vaccines to protect humanity from diseases. The Company aims to mitigate global vaccine distribution imbalances and indirectly contribute to reducing public health risks associated with antibiotic resistance by implementing a glocalization strategy in regions with insufficient vaccine production capabilities.
Safe Clinical Research
Complying with International Code of Ethics
SK bioscience conducts safe clinical research in accordance with international ethical regulations. We follow the ICH1) guidelines and KGCP2) which is domestic guidelines for conducting clinical trials. Other clinical trials are conducted after obtaining approvals from drug regulatory authorities in accordance with the regulations of the country in which they are conducted. We also comply with the principles contained in the Declaration of Helsinki, which are ethical principles for medical research involving human subjects.
- 1)ICH : International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- 2)KGCP : Korean Good Clinical Practice
- 전임상
- 암성1상
- 암성2상
- 암성3상
- 허가
Securing Clinical Trial Safety and Transparency
SK bioscience ensures the safety of clinical trials by strictly complying with the regulations and guidelines of Korea’s Ministry of Food and Drug Safety and the respective countries where the trials are conducted. In the preclinical stage, toxicity is tested in advance through animal testing, and the safety of subjects and the efficacy of the vaccine are evaluated at each stage of the clinical trials.
We ensure the transparency of our clinical trials by collecting and submitting all data on clinical trial approvals to the relevant regulatory authorities. Specifically, we prepare reports on serious adverse events that occur during the clinical process and report them to each regulatory authority. In addition, information on all interventional studies conducted by SK bioscience is registered and disclosed on the clinical trial information site operated by the U.S. National Library of Medicine, in accordance with the progress of the clinical trial.
Pursuing Diversity in Clinical Trials
The diversity of participants in clinical trials is an important factor not only for product development and success but also for equity. Recognizing this, SK bioscience conducts global clinical trials in various countries, including Korea, to collect data from participants of various races/ethnicities, ages, genders, and backgrounds. In the case of SKYCovione, one of the vaccine pipelines developed by SK bioscience, we have received approval based on data from Southeast Asia, Oceania, and Europe, in addition to Korea. Based on the safety data of SKYCovione, our aim is to secure diversity in terms of countries and ages in clinical trials for the next vaccines.
Clinical Trial Participant Safety & Practices
SK bioscience is committed to protecting the safety and rights of all clinical trial participants. Participants are asked to participate through a voluntary consent process after fully understanding the risks and benefits of clinical trials. Moreoever, blood sample collection is conducted with additional consent after providing sufficient information to subjects through a separate human-derived material informed consent form.
We have also established standards and procedures to compensate for damages that may occur during the clinical trial phase and have implemented safeguards for participants through the operation of the DSMB3). The DSMB consists of external, independent experts responsible for advising on whether to continue, modify, or terminate the clinical trial. They conduct periodic reviews and evaluations of the trial process, safety data, and, if necessary, critical efficacy endpoints. The board plays a crucial role in protecting the safety and rights of participants, including the decision to terminate a trial early after assessing the risks and benefits for participants.
In the process of conducting clinical trials, we have taken measures to ensure that participants can progress to the next stage only after completing safety reviews at each trial stage. We also adhere to standards that are stricter than international standards, such as setting the follow-up monitoring period to one year.
- 3)DSMB : Data Safety Monitoring Boards
Clinical Trial Quality Enhancement
Clinical Audits
SK bioscience conducts clinical audits as a procedure to ensure that clinical trials are conducted in accordance with ethical principles and standards. We conduct clinical audits in accordance with internal regulations such as protocols and SOPs, as well as domestic and international guidelines such as GCP1) and International Council for Harmonisation(ICH) guidelines, regulations of the IRB2), and the Helsinki Declaration.
Clinical audits are conducted by the Clinical QM team, an independent division separate from the team responsible for running clinical research, to ensure independence and credibility. The Clinical QM team develops a Quality Management Plan(QMP) and, based on this plan, establishes a detailed approach for each clinical audit to assess the appropriateness of the study’s operations. Furthermore, the team conducts in-house audits of materials and related documents to review the clinical trial process, safety and validity of data, appropriateness of documentation, and compliance with regulations. They also conduct on-site audits of clinical trial sites, analyze and review the gathered information, and report the results after the audit. By doing so, we aim to ensure that the principles of protecting the rights and welfare of clinical trial subjects, beneficence, and justice are upheld. Moreoever, we hope to improve systems and procedures in the new drug development process, and ultimately improve data quality.
Additionally, SK bioscience actively fulfills its supervisory role as a market authorization holder and clinical trial sponsor by strengthening the qualification evaluation and regular audit procedures for partner companies involved in clinical trials. This ensures the professionalism, reliability, and performance capabilities of these partners, enhancing the overall quality and integrity of the clinical trials conducted.
- 1)GCP : Good Clinical Practice
- 2)IRB : Institutional Review Board
Strengthening Clinical Audits Capabilities
SK bioscience’s clinical audit division is composed of internationally certified auditors and specialized personnel dedicated to the clinical trial quality of Global Clinical Trial. We are strengthening our clinical audit capabilities and the quality of clinical audits by providing key personnel with opportunities to participate in various seminars, conferences, and external trainings both domestically and internationally. Additionally, SK bioscience aims to enhance its international competitiveness by continuously increasing the number of certified "Reliability Assurance Professionals" who are internationally recognized for their high understanding of Good Clinical Practice (GCP) and related laws and regulations, and their ability to apply this knowledge. This initiative ensures that the Company maintains global-level expertise and strengthens the quality of clinical audits.
Improvement of the Clinical Trial Quality Management System
Recently, a risk-based approach has become prevalent in the pharmaceutical and bio-industries. Clinical trial regulations have been strengthened as the risks must be identified, evaluated, and reported during the clinical trial process. As the number of our research projects conducted abroad and business partners at home and abroad grows, so does the importance of clinical trial quality assurance and management.
Accordingly, SK bioscience operates a QMS3) to improve the efficiency and accuracy of clinical trial quality management. In early 2023, we enacted a QMS policy and included quality control and quality assurance activities for clinical trial data, training to strengthen employee competencies, and SOP management in the policy.
In 2023, by introducing an eQMS4) that digitizes the existing Quality Management System(QMS), we have reduced the time and cost spent and established a foundation to more actively cope with changes in the regulatory environment at home and abroad.
- 3)QMS : Quality Management System
- 4)eQMS : Electronic Quality Management System
Quality & Safety Management
Quality Management System
SK bioscience operates a strict quality management system that covers all stages of the product life cycle, from product development to consumer use. Our quality assurance system is optimized to continuously produce, manage, and sell pharmaceutical products in a GMP1) environment. In addition, we manage issues such as deviations and complaints with a system to produce high-quality pharmaceuticals.
We also perform qualification and validation of all facilities and equipment to ensure their performance and functionality. As such, we have established a quality policy to comply with all customer and legal requirements, as well as standards for quality assurance, facilities/equipment, raw materials, manufacturing control, packaging/labeling, and test management. Moreover, we raise the awareness of quality personnel by specifying essential compliance requirements in documents.
- 1)GMP : Good Manufacturing Practice
Quality System
-
- 생산 계획 / 원자재 입고
- 제품/공정 문서화
- 품질 정책 수립
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- 의약품 제조
- 생산 및 공정 모니터링 수행
- 품질보증 시스템 기반
-
- 출하 품질 보증
- 제품 시험 및 품질 평가
- 저격성 평가 및 밸리데이션 진행
-
- 판매 / 고객 품질
- 불량 분석/대응
- 고객 대응 전략 수립
- SK바이오사이언스
- 품질보증
- 설비 및 장비
- 원자재
- 제조관리
- 포장/라벨
- 시험관리
- 품질경영시스템의 효율적 운영
- 고객 요구사항과 법적 요구 사항을 충족하는 제품 생산
Quality Management Promotion System
SK bioscience has a system in place to ensure the smooth operation of the quality assurance system and GMP. Based on its annual and factory quality training systems, the Quality Assurance(QA) division supports risk analysis for quality management, performs deviation handling procedures, and operates a preventive action system. It also conducts evaluation and monitoring for installation, calibration, and maintenance of GMP-compliant facilities and equipment. Moreover, it oversees general quality management tasks such as product recall notification/investigation/record storage, supplier audit, and purchase change approval.
The Quality Control(QC) division examines raw materials, intermediate process samples, and final drug substances used in pharmaceutical manufacturing to check whether the specifications have been met. In this process, physics and chemistry, microbiology, animal testing, and device analysis tests are conducted according to Standard Operating Procedure(SOP). To this end, it carries out test method validation and management activities to maintain the functions of the QC laboratory, such as device qualification and CSV2). We are committed to continuous improvement of our quality system by monitoring our drug safety evaluation programs and manufacturing support facilities, regularly reporting the results to top management, and receiving feedback from management.
- 2)CSV : Computer System Validation
SK bioscience Quality Policy
- 1The quality organization must operate independently of the production organization.
- 2All employees who perform GMP must have appropriate qualifications and improve and maintain GMP level through training.
- 3All important manufacturing processes must be validated, and the quality standards established through validation must be reviewed regularly and kept up to date.
- 4All the facilities and systems required for GMP must be equipped.
- 5All work during the manufacturing process must be performed according to the approved method. All progress must be recorded and preserved in the manufacturing instructions and records.
- 6A recall system must be established and maintained.
- 7A complaint handling system must be kept in place, the cause of complaints that arise should be investigated. Appropriate measures to prevent the recurrence of the same complaints must be taken.
Quality Assurance Enhancement
Strengthening Quality Assurance
SK bioscience operates a quality management process that oversees and guarantees the pharmaceutical manufacturing process from raw material intake to final product shipment. By establishing and maintaining a quality management system, The Company ensures that it provides reliable products to customers. SK bioscience complies with the Korean Good Manufacturing Practice (K-GMP) standards across all its production facilities. Additionally, for products approved in international markets, SK bioscience has obtained EU-GMP certification from the European Medicines Agency (EMA), certification from the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and WHO Prequalification (WHO PQ) for its production sites. These certifications ensure that all production facilities meet internationally recognized third-party quality standards.
Best Quality Control
- 품질경영 실행을 통한 고품질 제품 생산:GMP 인증 획득, GMP 기준 최적화된 설비 구축 및 모니터링, 품질 영향평가 시행
- 품질경영시스템 구축: 품질관리 프로세스 수립, 품질보증 시스템 운영
- 품질보증 강화:품질보증 활동 수행, 품질보증 역량 강화 교육 진행
Quality Assurance Activities
SK bioscience pays special attention to diagnosing and managing product quality risks as we produce vaccine raw materials and finished drugs that are sensitive to temperature and environment. Products are stored and monitored at specified temperatures and environments. Commercialized products undergo annual safety tests to check their quality. Raw materials are also managed under proper storage conditions. In addition, for GMP compliance and process control, critical processes are managed and supervised on-site based on product standards, manufacturing records, and a guidebook. Moreover, QA on the shop floor policy* is implemented to ensure data integrity, and process deviations are handled on-site in real-time.
We continuously manage whether quality issues are improved and whether operations are in line with global GMP standards by conducting a quality impact assessment of products in the first half of each year. A validated eQMS is applied to the quality assurance system, allowing for comprehensive management of changes, deviations, corrections, and prevention, as well as deviations from standards, to be tracked in real time.
- *The QA on the Shop Floor Policy: A system that enables quality assurance personnel to participate directly in key processes to solve or respond promptly to problems when they occur. It is operated to prevent unnecessary process deviations.
Enhancing Quality Assurance Capabilities
We conduct quality assurance capacity-building training for product quality managers. We conduct regular training to strengthen GMP competencies. And new employees receive basic training and on-the-job training to ensure they have the necessary skills for their respective jobs.
Jobs that require special capabilities, such as quality testing and aseptic work, are strictly managed to ensure that only authorized employees perform such tasks through verification and qualification procedures. Therefore, our training programs provide not only training on common competencies such as quality system operation, production procedures, hygiene, and dress code but also detailed training for each specific job, as well as training to enhance the capabilities of each employee.
GMP Training Poster
Training for Strengthening Quality Assurance Capabilities
Quality Testing Management
SK bioscience ensures the reliability and management of quality tests for raw materials, intermediates, and final products using validated test methods, trained personnel, and certified equipment. To guarantee the quality and safety of all manufactured pharmaceuticals, we conducts precautionary tests for emerging quality and safety concerns. Also quality tests are conducted before shipment, with results reviewed and managed by the Quality Assurance department.
The tests are categorized into physicochemical, viral, microbiological, and animal tests. Certified personnel conduct these tests using pharmacopeia standards (USP, EP, KP, etc.)1) and validated test methods. A dedicated stability chamber2) is in place for stability studies, with continuous monitoring to collect stability data.
- 1)Pharmacopeia: Comprehensive collections of detailed information for pharmaceutical quality management, published by various countries, with prominent examples including the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Korean Pharmacopoeia (KP).
- 2)Stability Chamber: Equipment that provides various environmental conditions such as temperature, humidity, and light for stability testing.
Enhancing Supplier Quality
Under its quality management framework, SK bioscience operates a proprietary quality certification program to improve the quality systems of its suppliers across the supply chain. On-site quality assessments are conducted for all Tier 1 suppliers, evaluating manufacturing facilities, production processes, laboratories, and equipment according to relevant regulations and guidelines. For indirect suppliers (Tier 2), systematic quality management is ensured through inspections of Tier 1 suppliers' management systems and regulatory body audits. Regular quality inspections are also performed for all component/raw material suppliers (Tier 3), including excipients and packaging materials.
The Company provides continuous support and monitoring for strengthening the quality systems of its partners through a quality certification program with cycles ranging from 2 to 4 years based on supplier risk assessment grades. Regular quality inspections are conducted according to the Criticality Level (CL) of the raw materials, with quality checks performed on each delivery. For CL 1 materials, comprehensive quality inspections are conducted at least once a year.
Pharmacovigilance (PV)
Pharmacovigilance System
SK bioscience has established a pharmacovigilance(PV) process that spans the entire life cycle of a drug. Accordingly, we analyze adverse events collected from nonclinical and clinical trials in the development stage of a drug to identify potential risks of the drug and collect and evaluate expected adverse events based on these data.
In addition, during the post-marketing phase, we consistently gather adverse event data from pharmaceutical experts working with biopharmaceutical products, including vaccines, as well as from drug recipients. The purpose is to identify variables that were not anticipated during the development phase. The collected information is then stored in our database and utilized to conduct drug risk-benefit assessments. Based on these assessments, we carry out proactive safety management, such as minimizing the expected risk of adverse events by preparing various measures(providing precautions for use in the attached medication guides and manuals for pharmaceutical experts/consumers) to mitigate the risk.
Pharmacovigilance Training
All employees of SK bioscience receive regular pharmacovigilance training at least once a year to thoroughly manage the quality and safety of the products we produce. New hires are required to complete basic pharmacovigilance training within one month of joining the Company. Additionally, the marketing division, responsible for product sales, receives additional training beyond the regular one they receive once a year.
Pharmacovigilance Activities
SK bioscience has advanced its pharmacovigilance system to meet the pharmacovigilance requirements of global regulatory authorities. We have established a new SIRS1) and upgraded the Safety DB to a higher level.
In addition, we restructured the pharmacovigilance division to strengthen the expertise of our PV activities. We have divided the responsibilities of the existing pharmacovigilance division into two main areas: planning drug risk management and establishing risk mitigation measures, and conducting risk-benefit assessments based on collected safety information. This restructuring enables us to not only monitor the safety of drugs but also efficiently manage the information gathered during clinical trials and post-marketing activities, using it for effective product safety management.
Based on the Safety Internal Reporting System, employees can conveniently report adverse events to our products through the internal network. Meanwhile, we have signed a Safety Data Exchange Agreement with client companies and stakeholders who handle our products to exchange product safety information and take risk mitigation measures when necessary.
- 1)SIRS : Safety Internal Reporting System
Pharmacovigilance System Improvement
SK bioscience conducts the following practices to further advance our pharmacovigilance system.
01. Establishment of European Medicines Agency(EMA)-level Pharmacovigilance and Monitoring System
Since 2022, We have established and implemented the PSMF2) in accordance with the guidelines published by the European Medicines Agency(EMA), and we regularly update it twice a year. Although the PSMF has not yet been legislated in Korea, we are taking our efforts to establish the PSMF to the next level by striving to put in place an EMA-level pharmacovigilance and monitoring system. Additionally, we have revised and conducted our Standard Operating Procedures(SOP) to align with the pharmacovigilance practices of both the EMA and the UK’s Medicines and Healthcare products Regulatory Agency(MHRA) to improve our work system.
02. Establishment of Safety Signal Detection Procedures
In May 2023, we established a process to periodically review the collected data to detect Safety Signals for drugs. Subsequently, we will conduct periodic reviews of safety information gathered from various channels, as well as information on our products provided by regulatory authorities to detect unexpected risks and irregularities.
03. Enhancing Accessibility for Pharmaceutical Users through IT Systems
To improve access to risk mitigation measures for products, SK bioscience has made product manuals and explanatory materials for both patients and professionals available on the Company website. This initiative ensures that users can easily obtain necessary information about the products.
04. Internal Audits for Drug Safety Monitoring System
Starting in 2023, SK bioscience initiated internal audits of its pharmacovigilance system. These periodic internal audits verify that the current pharmacovigilance system is established in compliance with regulations and assess the detailed operational systems to ensure efficient and systematic performance. Based on the audit results, the Company continuously works to improve its operational framework, aiming to enhance the overall level of product safety management.
- 2)PSMF : Pharmacovigilance Systems Master File
Responsible Marketing
Responsible Marketing Policy
Marketing Compliance
SK bioscience conducts responsible marketing in compliance with relevant laws and regulations, including the Pharmaceutical Affairs Act, the Medical Service Act, the Fair Trade Act, and the Code of fair competition. To this end, we have established compliance regulations and put in place detailed guidelines for providing economic benefits to healthcare professionals.
In 2023, SK bioscience published and distributed a Fair Trade Compliance Handbook to all employees. This handbook aims to enhance understanding and adherence to laws related to fair trade, the Pharmaceutical Affairs Act, and fair competition regulations. It includes the fundamental principles and guidelines of fair trade, aiming to ensure transparency and fairness in marketing activities. This initiative underscores the Company's commitment to ethical practices and compliance with relevant laws.
We also contribute to protecting consumers and creating a fair competition environment in the industry by complying with laws and regulations related to fair trade and strictly regulating activities related to promotion and advertising. In particular, to prevent false and exaggerated advertisements, we specify the basic principles and scope of advertising for pharmaceuticals and establish detailed compliance guidelines for quasi-drug advertising to minimize the possibility of product misuse.
When producing promotional materials used by our marketing division, we use an internal review process called the RED system. It allows us to cross-check whether there are any violations from the medical, licensing, and legal perspectives. We do not conduct any marketing or promotion that may induce prescription of off-label products1).
- 1)Off-label Products : Unapproved medical supplies or products
Monitoring Process for Responsible Marketing
We ensure that our sales partners participate in fair trade by conducting annual monitoring of marketing and promotional activities and obtaining fair trade agreements from them.
To ensure compliance with marketing activities in advance, any expense discussions must be agreed upon by the Compliance Division. In addition, after expenses have been incurred, an expense report is prepared, and compliance with the fair competition code is checked through monitoring. If any violations are detected as a result of monitoring, penalty points are assigned, and disciplinary procedures are initiated in accordance with Article 14(Sanctions against Employees) of the Compliance Regulations. These results are then reflected in both organizational and individual KPIs and disclosed to all members.
Regular monitoring process for marketing and promotion activities
- CP규정 운영
- 준법교육 (CP교육)
- 마케팅 활동 상시 모니터링
- 위반 점수 부여 및 KPI 반영 징계
CP(Compliance Program) Check of Marketing Activities
- 사전 합의:CP 사전 합의 의무, 판촉 활동에 대한 승인
- 보고서 제출:세부 증빙을 포함한 지출내역 보고서를 시스템에 작성·보관
- 모니터링:집행 적정성 모니터링, 모니터링 결과를 개인/조직 KPI 평가에 반영
- 피드백:위반 발생 시 결과 피드백
Marketing Compliance Training
SK bioscience conducts annual training sessions for relevant divisions on compliance with various marketing activities. We strive to establish a fair drug distribution order by providing detailed training on compliance regulations to be observed in marketing/digital marketing activities. The training covers the Pharmaceutical Affairs Act, the Fair Trade Act, and the Code of Fair Competition as well as how to write an expense report.
2023 Marketing Training Status
| Content | Target | Date |
|---|---|---|
| Marketing CP training (CP regulations, CP KPI standards, CP violations, etc.) | Marketing & Sales Office | 1st Half : April 25~26, 2023 2nd Half : July 7, 2023 |
| Training of the Fair Trade Act | Marketing & Sales Office | July 7, 2023 |
Customer Satisfaction Strategy
Vision & Strategy for Customer Satisfaction
Vision
The Company must continuously satisfy customers to gain trust from customers and ultimately develop together with them
Strategy
- A unified system from licensing to sales
- Strategies specialized for each public and private market
- Portfolio that encompasses infants, children, and adults of all ages
Customer Classification
SK bioscience categorizes its customers into distinct segments, including public and private as well as domestic and international markets for effective management.
- 연구개발부터 상업화까지 진행한 자체개발 백신(SKYVAX)의 국내 영업, 타사 상품 도입 및 국내 유통판매의 경우 당사의 마케팅 조직에서 고객사 커뮤니케이션을 담당함
- 해외 코로나19 백신의 C(D)MO 계약 체결 및 자체 개발 백신(SKYVAX)의 해외 수출의 경우 국제기구 및 정부 입찰 계약을 통해 제품이 공급되므로 각 프로젝트 및 계약 담당자가 고객을 관리함
Product Information Provision and Consultation
SK bioscience operates a customer service center to address inquiries and provide counseling for products distributed to hospitals and clinics. Our professional consultation staff responds promptly to customers’ questions regarding common adverse events or purchases, aiming to minimize consumer anxiety and inconvenience. In addition, we prioritize quality control, safety, accurate information delivery, and cold chain distribution when distributing and selling vaccines. We also communicate key points to our customers, such as safety information obtained during product approval. Moving forward, we will continue to deliver messages that emphasize the superior quality, safety, and effectiveness of our products and implement marketing strategies that lead to customer satisfaction.
Example of Product Information Provision for Customers(SKYVaricella Manual)
Adverse Event Consultation
SK bioscience collects adverse events reported by pharmaceutical experts and end-users at the customer service center. The gathered information is then transferred to the pharmacovigilance division through our safety information reporting system and feedback, such as medical information, is provided when necessary. Additionally, we conduct risk-benefit assessments of drugs using the information accumulated through various channels. We also distribute explanatory materials for patients and professionals to ensure that customers can use our products safely.
Domestic Customer Communication
SK bioscience actively communicates with domestic customers through various channels. Our customers include major client companies and general consumers, foreign pharmaceutical companies that import our products, and partners who are authorized to jointly market our products. We have offices in the Seoul Metropolitan area and provinces to facilitate active interactions with customers and regulatory authorities, which are critical when expanding the vaccine business and promoting new businesses.
To actively communicate with key stakeholders, SK bioscience conducts online and offline meetings led by the Steering Committee and relevant working-level employees. Executives and working-level employees from each company meet periodically to discuss major marketing plans for each product, as well as quarterly, monthly, and annual plans, as outlined in their respective contracts.
Customer Satisfaction Support Activities
At the end of each year, SK bioscience establishes an annual conference promotion plan for customer support and communication for the following year, and conducts support activities to maximize customer satisfaction. We engage in various promotional activities at both domestic and international conferences to contribute to improving public health and the medical environment for healthcare professionals through our self-developed vaccines.
In 2023, we participated in the Asian Pneumococcal Symposium (APS) as a gold sponsorship package and introduced domestic vaccine development technology and capabilities to medical professionals from across the world. In addition, we conducted a total of 56 booth/abstract support and advertising activities in Korea.
Satisfaction Survey for Domestic Customers
SK bioscience conducts satisfaction survey on an annual basis for domestic customers to diagnose the service status, analyze customers’ needs, and implement improvement activities. To boost customer satisfaction and expand the service, we establish the scope of regular customer satisfaction surveys, and the results are reflected in the customer satisfaction strategy using a qualitative method. Also, we hold regular meetings with licensees and partners, and depending on the nature of the meeting, each session is classified as a Joint Steering Committee meeting or a working-level KPI meeting.
We listen to customer feedback and develop or supplement annual marketing plans through those meeting held once a month or quarterly. In addition, partners handling our products operate their counseling channels via online malls. They have a system to listen to customers’ opinions and inquiries and deliver feedback. In this way, BP’s personnel delivers feedback received from customers and gets back to the customers with our replies.
SK bioscience values the opinions of our customers and will continue to actively engage in regular meetings and partner communication. We will strive to provide better services and products to our customers based on the feedback we receive.