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GLOBAL PATIENT SAFETY

Information About Global Patient Safety

Amgen is committed to patient Safety and the Global Patient Safety Department is responsible for oversight of Pharmacovigilance activity. Patient safety is our highest priority. To fulfill our commitment to patient safety, Amgen’s Global Patient Safety Team applies a comprehensive, continuous and rigorous approach to pharmacovigilance. Pharmacovigilance is the science of monitoring, reviewing, evaluating and communicating information on the safety of pharmaceutical products. Since patient safety is so critical, we believe it is important that we share our approach to pharmacovigilance and our commitment to patient safety.

Amgen’s Global Patient Safety Mission

Amgen’s overall mission is to serve patients, which we consider a privilege. One element of that overall mission is the Global Patient Safety Team’s Mission:

Optimize the safe use of Amgen products through continuous Benefit-Risk assessment and communication.

Amgen’s Approach

To fulfill that mission, we continually evaluate benefits and risks of our products with the implementation of risk management plans that maximize their safe use. Our experienced safety experts conduct a rigorous pharmacovigilance program in order to detect and evaluate safety signals across the product life cycle. Our signal and risk management processes, combined with our robust safety governance framework allows Amgen to determine if new safety information on our product (a ‘signal’) poses a risk to patients and how best to manage, mitigate and communicate the risk. Our safety experts are medical and scientific professionals with extensive safety and/or clinical or healthcare experience who are trained in drug safety, pharmacovigilance and worldwide health authority regulations relevant to drug safety.

Continuous Safety Data Collection and Monitoring

Amgen is committed to compliance with the applicable worldwide regulations regarding collection and review of information regarding Adverse Events, Product Complaints, and Other Safety Findings experienced by patients and clinical trial subjects taking our approved or investigational products. This information helps us better understand drug safety profiles and deliver safer products to patients.

Amgen gathers and analyzes safety data throughout a product’s life cycle. Product safety is rigorously evaluated during the development process through clinical trials. Once a product is approved, safety data collection continues through multiple pathways, including additional clinical studies, reports by patients and health care professionals, registries, scientific literature, and database reviews.

Amgen’s Safety Governance Framework

The Safety Governance Framework is designed to ensure that all safety data is appropriately analyzed and appropriate actions are taken to protect patient safety. Potential Safety signals identified undergo further thorough assessment and are evaluated through Amgen’s safety governance structure to determine whether new safety information constitutes a risk to patients.

Amgen’s Safety Governance Framework is comprised of cross functional governance teams which brings together individuals with Pharmacovigilance, medical and regulatory expertise. These teams are responsible for characterizing the safety profile for all products in development and post approval. This is accomplished through a continuous evaluation of safety information in order to identify ‘signals’ (or information that might indicate that an adverse event might be linked to the use of the drug) and determine which signals represent a safety risk for patients.

If a safety risk in the form of a newly identified adverse reaction is identified, our experts determine how best to prevent, minimize or mitigate those risks, and execute timely, transparent and accurate communication regarding those risks to patients, prescribers and Regulatory Agencies across the globe (e.g., FDA in the USA, EMA in Europe, MHRA in the UK and PMDA in Japan etc.)

Risk Communication

Amgen is committed to timely, appropriate and transparent communication of risks related to our products to Patients, Health Care Professionals, and Regulatory Agencies. For developmental products, the risks are communicated to investigators through the investigator brochure, as well as through the updates to informed consent. Subjects participating in our trials will receive the information via 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. 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 health care providers are used as appropriate for timely communication of a new important risk.

Benefit Risk Assessment of Our Products

Amgen conducts ongoing benefit/risk assessment of our products through signal detection and risk management processes. Amgen routinely communicates benefit-risk assessments of our products to regulatory agencies by submitting aggregate periodic reports which are evaluated by applicable regulatory agencies.

Patient Choice

Amgen is committed to providing accurate, up to date and transparent information to patients and their prescribers on all the risk and benefits related to our products. We understand that the ultimate use of the product depends on the individual benefit/risk decision made by patients and their prescribers.

Compliance and Quality

Amgen‘s Global Patient Safety department is committed to compliance with the applicable worldwide regulations. We maintain oversight through regular monitoring of compliance metrics as well as internal process audits. We also audit our suppliers and business partners to ensure adherence to pharmacovigilance processes.

Collaboration With Regulatory Agencies

Amgen works collaboratively and transparently with world-wide regulatory agencies to achieve the common objective of protecting patient safety. During clinical development of a product, we actively solicit input and work with Regulatory Agencies to evaluate the safety and efficacy of our products. Our Marketing Applications to Regulatory Agencies include required, relevant and available data required for a thorough safety and efficacy review of the product to allow the Regulatory Agencies to make the right decision regarding allowing products on the market. After the approval of a product, we continue to inform Health Authorities on the safety of our products through expedited individual case safety reports, periodic aggregate safety reports, clinical study reports, and other relevant communication on safety issues in a timely and compliant manner.

European Qualified Person for Pharmacovigilance

In compliance with European regulations, Amgen has appointed a European Qualified Person for Pharmacovigilance (EU QPPV) who acts as an advisor to Head of Global Patient Safety on all matters related to the safe use of Amgen products in the European Region. Amgen’s EU QPPV ensures compliance of our safety procedures with European regulations and acts as point of contact for regulatory authorities. The Office of the EU QPPV maintains the Pharmacovigilance System Master File (PSMF) which summarizes our pharmacovigilance system and is used by Regulatory Agencies to understand Amgen’s processes.

Patient Safety Across the World

Amgen is committed to ensuring safety of our patients and safe use of our products in all markets where we market Amgen products. We have a network of in-country based Local Safety Officers who ensure that safety data are collected locally and shared with the Amgen Global Patient Safety Department, and appropriately communicated to Local Regulatory Agencies as well as Patients and Prescribers worldwide. Responsibilities for ensuring the safe use of our products in some countries may be shared with our business partners.