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Product Safety Management
Product Safety Management
Safe Clinical Research
Complying with International Code of Ethics
SK bioscience conducts safe clinical research in accordance with international ethical regulations. We follow the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) guidelines and 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.
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 and 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 Data Safety Monitoring Board(DSMB). 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.
Clinical Trial Process
Enhancing the Quality of Clinical Trials
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 Good Clinical Practice(GCP) and International Council for Harmonisation(ICH) guidelines, regulations of the Institutional Review Board(IRB), 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.
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. Furthermore, recognizing that clinical audit capabilities are crucial for new drug approval and the consumption of our new drugs by the general public, we plan to continuously recruit specialized personnel with sufficient knowledge and experience.
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 quality management system(QMS) 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. We plan to introduce an electronic quality assurance system(eQMS) in 2023. Through this system, we aim to proactively address environmental changes including domestic and international regulations, by improving clinical trial quality and promptly responding to related issues.
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 ensure that they understand the importance of pharmacovigilance and learn the necessary actions to take when they become aware of adverse event information. This ensures thorough management of the quality and safety of our products. New hires are required to complete basic pharmacovigilance training within one month of joining the company. Additionally, the marketing division, responsible for product sales and frequently interacting with pharmaceutical experts, receives additional training beyond the regular one they receive once a year.
Pharmacovigilance System Improvement
SK bioscience has upgraded its Pharmacovigilance System Master File(PSMF) to the level of the European Medicines Agency(EMA) in 2022. In addition, we have established procedures for detecting safety signals of drugs and provide safety information on drugs through our website to ensure that users can easily access the information they need.
Pharmacovigilance System
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Establishment of European Medicines Agency(EMA)-level Pharmacovigilance and Monitoring System
We have established and implemented the Pharmacovigilance System Master File(PSMF) 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 our standard operating procedures(SOPs) 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.
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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.
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Efforts to Increase User Accessibility to Drug Safety Information
We provide product manuals, patient manuals, and explanatory materials for experts on our website to make it easier for users to understand how to mitigate the risks of our products. In addition, we are dedicated to consistently ensuring that product safety information remains easily accessible to users while complying with future domestic regulations.
Pharmacovigilance Activities
SK bioscience has advanced its pharmacovigilance system to meet the pharmacovigilance requirements of global regulatory authorities. We have established a new Safety Internal Reporting System(SIRS) 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.