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Patient safety

Through a rigorous benefit-risk management process, we help to ensure that the benefits of our medicinal products always outweigh the risks for patients. Every new medicine goes through a series of precisely defined development stages. Before any medicinal product is administered to human subjects, we conduct extensive preclinical testing both in vitro and in vivo. During clinical development, we diligently use all the collected data to continuously evaluate the medicinal product’s benefit-risk profile. If we consider the medicinal product’s benefit-risk profile to be positive, we then submit an application for marketing authorization to the relevant regulatory authorities.

Continual monitoring of product safety risk profiles

Once we launch a new medicinal product, the number of patients being treated with the product increases significantly. In rare circumstances, there may be adverse and potentially serious effects that were not detected during clinical development, which is why we continuously monitor risks and assess the benefit-risk profiles of the products after their market launch. Pharmacovigilance includes the process of monitoring a medicinal product on an ongoing basis to detect and assess safety signals as part of signal management activities. Our pharmacovigilance system and our pharmacovigilance business continuity management help to ensure continuous monitoring of adverse effects, allowing us to proactively and transparently minimize and communicate any risks. Emergency response procedures for business continuity are managed in accordance with global and local business continuity plans, tested in regular, defined intervals or with mock scenarios. In addition, we provide healthcare professionals and patients with the latest information on the safety of our marketed medicinal products. The scope of continuous safety monitoring covers the entire life cycle of a product, ranging from development, market launch and commercialization to the expiration or cancellation of its marketing authorization.

By 2025, we aim to deliver product specific safety and benefit-risk strategies to support the execution of all key priority programs in line with internal and external stakeholders’ expectations. These strategies will enable us to understand in greater detail the benefit-risk profiles at each stage of product development and post-marketing. During the reporting year, we worked toward achieving this goal by providing high-level safety and benefit-risk contributions for development programs with priority in oncology, neurology and immunology.

Roles and responsibilities

Our Global Patient Safety unit is responsible for drug safety. It continuously collects current safety data from a wide variety of sources across the globe, including clinical studies, early access programs, spontaneous reports on adverse effects, patient support programs, and articles published in medical and scientific journals. Our vision is to embed a deep knowledge of safety into early decision-making as we evolve to practice predictive safety.

Our experts help to ensure that all information on the risks and adverse effects of our medical products are properly documented, tracked and reported to the respective health authorities in accordance with regulatory requirements. Our Global Patient Safety unit analyzes all data and reassesses the benefit-risk profile based on these data, where required. We then inform regulatory authorities, healthcare professionals and patients about new risks, additional risk mitigation measures and potential changes in the benefit-risk profile. We convey this information through stipulated regulatory reports, safety communications (as applicable) and corresponding product label updates.

Our Global Patient Safety unit hosts a Pharmacovigilance Intelligence Council that focuses on changes in pharmacovigilance legislation and their impacts on our global and local pharmacovigilance systems. This council enables us to make strategic decisions and govern changes in pharmacovigilance requirements, which fosters our target to ensure continuous compliance with regulatory requirements.

Our Medical Safety and Ethics Board

Our Medical Safety and Ethics Board (MSEB) is the governance board that oversees the safety and benefit-risk assessments of our medicinal products throughout their clinical development and commercialization. This internal board is chaired by our Chief Medical Officer and comprises experienced physicians, scientists and experts from our company. Throughout a medicinal product’s entire life cycle, the MSEB reviews and assesses important medical safety risks and benefit-risk issues and endorses appropriate measures to minimize risks, such as updates to product information. The MSEB also assess human-related bioethical matters as appropriate and is accountable for the use of our medicinal products in early and post-study access.

Our commitment: Guidelines and statutory requirements

We rigorously aim to follow international guidance and standard procedures. These include the International Council for Harmonisation (ICH) guidelines, the Good Pharmacovigilance Practices (GVP) established by the European Medicines Agency (EMA), Title 21 of the Code of Federal Regulations governed by the U.S. Food and Drug Administration (FDA), and other pharmacovigilance regulations issued by national health authorities. We also aim to comply with relevant new statutory pharmacovigilance regulations in the countries where we market our products.

Inspections and audits for drug safety monitoring

Regulatory authorities conduct periodic inspections to verify that we comply with statutory requirements as well as our own internal pharmacovigilance standards. We follow up on the findings of health authority inspections and take necessary actions to ensure the ongoing compliance of our pharmacovigilance system. In 2023, we had five pharmacovigilance inspections (2022: four).

We also perform audits to our systems and processes to ensure that all our units and subsidiaries involved in pharmacovigilance consistently meet all global requirements. In 2023, we conducted a total of seven pharmacovigilance audits (2022: 19) and found no significant deviations in our pharmacovigilance systems from these requirements and standards. We also conducted twelve external audits (2022: 16) at our vendors and licensing partners involved in pharmacovigilance, helping us to improve our pharmacovigilance processes and to comply with regulatory requirements.

Applying our proactive safety strategy to benefit-risk assessments

Regarding product safety risk assessments, we have successfully implemented in the past years an improved benefit-risk management strategy to become a more proactive and benefit-risk-focused organization. This strategy firmly establishes the concepts and principles for conducting benefit-risk assessments at each stage of product development and post-marketing. In addition, our Benefit-Risk Action Team co-leadership model, created in 2022, enables us to understand in even greater detail the benefit-risk profiles of our products and enable early decision-making within our organization to protect patient safety. Ultimately, we aim to provide the right medicine to the right patient at the right time.

Up-to-date labeling and product information

Our product information explains to healthcare professionals and patients how to correctly use the respective product and make informed treatment decisions. We review and update product information documents, such as package leaflets, thereby, we want to ensure our medicinal products contain the latest information on safety, efficacy and pharmaceutical formulation. In accordance with regulatory requirements, we submit modifications to our leaflets to the respective regulatory authorities for approval. In 2023, there were no reportable incidents of non-compliance with regulations concerning the labeling of our medicinal products.

Internal and external training

Our pharmacovigilance experts are regularly trained so that they gain and maintain the required experience and knowledge to carry out their activities. We manage our training via a global learning platform and verify compliance with our training requirements by producing training completion reports.

Our approximately 25,000 internal and external Healthcare employees receive basic pharmacovigilance training once a year that covers the procedure for reporting adverse effects or special circumstances associated with the use of our medicinal products.

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