What We Do
Pharmacovigilance is a comprehensive set of activities focused on the detection, assessment, understanding and prevention of adverse effects or other product-related problems. Amgen’s rigorous pharmacovigilance program is executed by the Global Patient Safety Team over the lifecycle of our products.
Safety Data Collection
Amgen collects, reviews, and evaluates adverse events, product complaints, and other safety findings experienced by patients, either as clinical trial participants who receive our investigational drugs or by patients taking our approved products. This information helps us better understand, assess, and communicate the safety profile of Amgen products.
Amgen collects and analyzes safety data throughout a product’s lifecycle. Adverse events for our products are rigorously evaluated during the development process and clinical trials. It is important to continue to collect adverse events and other safety information associated with the use of our products after the product has been approved for use on the market, as more patients are using them. Through data analysis/assessment of these events, and combined with the pre-approval information, Amgen can support the safety management of these products. This information comes through various channels, including additional studies, reports by patients and health care professionals, registries, scientific literature, medical literature, health authority databases, and other external database reviews. We also monitor Amgen-sponsored social media for adverse events, product complaints, and other safety findings. Individual adverse event reports are added to our safety database. If a safety risk is identified, our safety professionals determine how best to prevent, minimize, or mitigate those risks, and accurately communicate those risks to patients, healthcare professionals, and regulatory agencies in a timely manner. Amgen routinely communicates benefit-risk assessments of our products to regulatory agencies by submitting aggregate periodic reports.
Learn more: Adverse Event and Product Complaint Reporting
Safety Governance Framework for Risk Assessment and Evaluation
Amgen’s safety governance framework is composed of cross-functional governance teams, which bring together individuals with pharmacovigilance, medical, regulatory, quality, and other relevant expertise. Leveraging external expertise when needed, the teams analyze potential safety signals and are responsible for characterizing the safety profile for all products in development and once they are approved.
Amgen continuously monitors safety information from different sources to identify safety signals that could potentially suggest new adverse events might be linked to or associated with the use of our products. Risk evaluation or signal detection can take the form of qualitative review of individual cases and/or use of quantitative methods to assist with the review of aggregate data. Appropriate statistical methods and data mining techniques are applied to databases with a large volume of safety data to better detect signals in a timely manner. In addition, product quality monitoring, in the context of adverse events, is also employed to detect safety signals related to the complex manufacturing processes of our biological medicines.
Signal detection activities for an Amgen product initiate as soon as the first subject begins to receive an investigational product in a clinical trial and continues throughout the product lifecycle. The strategy of signal detection for each Amgen product is individually tailored depending on its stage of the product lifecycle and safety profile.
Signals identified through review of safety data undergo further assessment and are evaluated to determine whether new safety information constitutes a risk to patients.
Product Risk Management
Amgen conducts ongoing benefit-risk assessments of our products as new benefit or risk information related to the product becomes available throughout the product lifecycle. Amgen has in-place a structured risk management planning process to establish appropriate and necessary actions needed to communicate and minimize the risks of a product both during clinical trials and when the product is on the market. Our process is designed to engage the right expertise in the benefit-risk assessment and the development of any risk minimization activities. Through the implementation of risk minimization activities, some of the risks associated with the use of a product may be mitigated or managed in patients. Amgen routinely communicates benefit-risk assessments of our products to regulatory agencies by submitting aggregate periodic reports.
Product Risk Communication
Amgen is committed to timely, appropriate, and transparent communication to patients, healthcare professionals, and regulatory agencies of risks related to our products. For developmental products, the risks are shared with investigators through the investigator brochure. Subjects participating in our trials receive safety information during the informed consent process and through discussions with study investigators. For our marketed products, prescribing physicians and other healthcare professionals are informed through product labeling; they may use this information to counsel patients on the benefits and risks. There is also communication directly to patients through documents that use patient friendly language. Regulatory authorities have the final decision regarding the content and language included in the prescribing information and as a result, labeling documents may vary across countries or regions where the product is approved for commercial use. We also communicate any new clinically significant safety information through direct letters to investigators and/or healthcare providers, when appropriate.
During the clinical development of a product, Amgen partners with regulatory agencies around the world to evaluate the safety and efficacy of our products. Our marketing applications for product approval include comprehensive safety and efficacy data. Following approval, Amgen continues to inform health authorities on the safety of our products through expedited individual case safety reports, periodic aggregated safety reports, clinical study reports, and other relevant communication on safety issues consistent with applicable regulations. On a regular basis, Safety teams monitor health authority regulations around the world and update processes, as needed, to ensure compliance.