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 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 always provide healthcare professionals and patients with the latest information on the safety of all our marketed medicinal products. The scope of continuous safety monitoring includes the entire life cycle of a product, ranging from development, market launch and commercialization to expiration of the marketing authorization.
Roles and responsibilities
Our Global Patient Safety unit is responsible for pharmacovigilance. 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 is 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.
Our Global Patient Safety unit hosts a Pharmacovigilance Intelligence Council that focuses on changes in pharmacovigilance legislation and its impacts on our global and local pharmacovigilance systems. This initiative 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) 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 furthermore reviews human-related ethical issues as appropriate.
Our commitment: Guidelines and statutory requirements
Our aim is to follow international guidance and standard procedures, such as the International Council for Harmonisation (ICH) guidelines and the Good Pharmacovigilance Practices (GVP) established by the European Medicines Agency (EMA) and national health authorities. Furthermore, we aim at complying with all 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 2022, we had four pharmacovigilance inspections.
Furthermore, we perform audits to ensure that all our units and subsidiaries involved in pharmacovigilance consistently meet all global requirements. In 2022, we conducted a total of 19 pharmacovigilance audits and found no significant deviations in our pharmacovigilance systems from these requirements and standards. We also conducted 16 external audits at our vendors and licensing partners involved in pharmacovigilance, helping us improve our pharmacovigilance processes and comply with regulatory requirements.
Applying our proactive safety strategy to benefit-risk assessments
With regard to product safety risk assessments, we have implemented an improved benefit-risk management strategy in order to become a proactive and benefit-risk-focused organization. In this context, we developed in 2021 the concepts and principles for conducting benefit-risk assessments at each stage of product development and post-marketing. Along with the implementation of the redesigned benefit-risk strategy, the new Benefit Risk Action Team co-leadership model was rolled out in 2022. This redesigned approach will enable us to understand in even greater detail the benefit-risk profiles of our products, enabling early decision-making within the organization to protect patient safety. Ultimately, the aim is to be able 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 all product information documents, such as package leaflets, to ensure our medicinal products contain the latest information on safety, efficacy and pharmaceutical formulation. In accordance with regulatory requirements, we submit all modifications to our leaflets to the respective regulatory authorities for approval. In 2022, there were no significant 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 24,000 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 products.