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
In compliance with the applicable worldwide regulations, Amgen is committed to collect, review, and evaluate information regarding adverse events, product complaints, and other safety findings experienced by clinical trial subjects who receive our investigational drugs and by patients taking our approved products. This information helps us better understand, assess, and communicate the safety profile of Amgen products and allows us to deliver safer products to patients.
Amgen collects and analyzes safety data throughout a product’s life cycle. Product safety is rigorously evaluated during the development process through clinical trials. Not all adverse events associated with the use of a medicinal product are observed in clinical trials. It is therefore important for us to continue to collect adverse events associated with the use of our products even when the product has been approved for use on the market. Once the product receives marketing approval from health authorities, safety data collection continues through multiple channels: additional clinical studies, reports by patients and health care professionals, registries, scientific literature, and external database reviews.
Individual adverse event reports are continuously added to our safety database, and they help contribute to the overall understanding of the safety profile of our products.
Click on Adverse Event and Product Complaint Reporting to see how you can report an Adverse Event to Amgen.
Safety Governance Framework for Risk Assessment and Evaluation
Global Patient Safety utilizes a decision-making framework to identify, communicate, and mitigate product safety risks. Amgen’s safety governance framework is comprised of cross-functional governance teams which bring together individuals with pharmacovigilance, medical, regulatory and other relevant expertise. By working in teams, we are able to achieve quality results, leveraging expertise from internal and external collaborators as needed to analyze potential safety signals. These teams are responsible for characterizing the safety profile for all products in development and post approval.
Amgen continuously monitors safety information from different sources in order 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 in order 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 medicinal product in a clinical trial, and continue throughout the product lifecycle. The strategy of signal detection for each Amgen product is individually tailored depending on its stage of the product lifecycle.
Signals identified through review of safety data undergo further assessment and are evaluated to determine whether new safety information constitutes a risk to patients. If a safety risk is identified, our experts determine how best to prevent, minimize, or mitigate those risks, and accurately communicate those risks to patients, prescribers, and regulatory agencies in a timely manner.
Product Risk Management
Amgen conducts ongoing benefit/risk assessments of our products whenever new benefit or risk information related to the product becomes available. 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. Our process is designed to engage the right stakeholders 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 which are evaluated by applicable regulatory agencies.
Product Risk Communication
Amgen is committed to timely, appropriate, and transparent communication of risks related to our products to patients, healthcare professionals, and regulatory agencies. For developmental products, the risks are communicated to investigators through the investigator brochure, as well as through updates to informed consent forms. Subjects participating in our trials will receive the information via the informed consent process and discussions with study investigators. For marketed products, the risks are communicated to prescribing physicians and other healthcare professionals through product labeling, and to patients through updates to the product label, as well as patient leaflets, if required. 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. In addition to updates of the relevant documents for any new clinically significant safety information, other risk minimization communication tools, such as direct letters to investigators and/or healthcare providers, are used as appropriate for timely communication of a new risk.
Amgen works collaboratively and transparently with world-wide regulatory agencies to achieve the common objective of protecting patient safety. During the clinical development of a product, Amgen partners with regulatory agencies to evaluate the safety and efficacy of our products. Our marketing applications include comprehensive safety and efficacy data that regulatory agencies use to make their decision with regards to product approval. Following approval, Amgen continues to inform health authorities on the safety of our products through the submission of expedited individual case safety reports, periodic aggregate safety reports, clinical study reports, and other relevant communication on safety issues in a timely manner consistent with applicable regulations.