Material Risks CSL is also exposed more broadly to external risks such as the escalating trend of cyber threats and data privacy breaches or rapidly changing governmental requirements. Managing risks includes both mitigating disruptive risks and seizing opportunities. CSL’s Global Enterprise Risk Management Framework is designed to provide robust risk oversight that is fit‑for‑purpose for both the operation of CSL’s business and to support CSL’s strategy and deliver on CSL’s commitments to patients and public health. As part of CSL’s enterprise risk management process, the Board and management team have identified the key risk categories that are material to CSL. These material group risks are described below along with an explanation of CSL’s approach to managing them in the context of delivering on CSL’s Strategy. Key financial risks are set out in Note 11 (Financial Risk Management) to the Financial Statements. There are other risks for the CSL Behring, CSL Seqirus and CSL Vifor business, besides those detailed here or in the Financial Statements, or Promoting Safety and Wellbeing and Healthier Environment sections that could also adversely affect CSL’s business and operations. These risks are not covered in this report as they are not considered material to CSL’s overall operations and financial position. Patient safety and product quality Patient safety is paramount for CSL’s ongoing sustainability as a global biotechnology leader and CSL’s long‑term strategy of efficiency and reliable supply. When CSL talks about patient safety, CSL means both in the use and administration of registered products as well as in the conduct of CSL clinical trials. Occasionally, patients and trial participants experience adverse reactions to therapies. CSL’s manufacturing, product quality assurance and pharmacovigilance practices serve to provide high standards of safety and preserve CSL’s reputational integrity. CSL’s processes and procedures adhere to global good pharmacovigilance practice (GPV) and good clinical practice (GCP) standards to update product information to include relevant information to assist healthcare practitioners to appropriately prescribe CSL products. For clinical trials, CSL prioritises informing participants about their disease (if applicable) and the investigational therapy involved in the trial before obtaining consent. Participants are informed about and acknowledge awareness of the potential benefits and risks of participation in the trial through use of Informed Consent Forms approved by relevant regulators, institutional review boards and independent ethics committees. Comprehensive qualitative and quantitative safety signal detection activities are performed throughout the development programs and the lifecycles of CSL’s marketed products. In terms of meeting product quality requirements through CSL’s manufacturing and supply processes, CSL adopts and complies with a broad suite of internationally recognised standards through the CSL Quality Management System, including good manufacturing practice (GMP), and good distribution practice (GDP) that includes audits of third‑party vendors and suppliers. CSL is frequently inspected by independent regulatory authorities auditing compliance with these standards and CSL responds to any findings should they occur. Product innovation and competition CSL recognises that a key challenge to delivering on its innovation and sustainable growth strategies is the rapidly evolving competitive landscape for new technologies and disruptive therapies, such as gene and cell therapies. This material risk may alter the economics and characteristics of, and the demand for, CSL’s plasma and adjacent therapies, and may also affect the platforms and capabilities in plasma protein technology, recombinant protein technology, genetic medicine and vaccines technology. CSL commits to seeking out new and unexplored avenues to address the most pressing medical challenges. CSL keeps investing in targeted and disruptive R&D innovation to better meet the needs of patients and public health. CSL strategically reviews its existing and future product pipeline against unmet need and market demand while continually evaluating the competitive landscape. A key part of CSL’s strategy is scientific and therapeutic diversity, underpinned by a multi-platform approach. This includes robust lifecycle development and management of existing products and the development of novel therapies across CSL’s therapeutic areas. Aside from proprietary research, CSL actively pursues strategic opportunities through licensing, acquisitions and partnerships to remain competitive and drive sustainable growth. CSL also acknowledges the inherent risks in clinical development of new therapeutic and disease areas. These include higher initial failure rates and operational complexities due to the potential for knowledge gaps in scientific, medical or the regulatory environment, and the uncertainty of therapeutic outcomes. CSL operates in a fast-paced and constantly evolving environment of science, technology and healthcare. There are many risks when operating in these environments and industries; as in research and development, intellectual property, regulatory compliance and clinical trial risks. However, CSL regularly reviews its group risk profile to identify and assess material business risks. This includes external and emerging risks that could affect CSL’s global operations. 24 Performance
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