Adverse Event Information

Part of Amgen's Mission to serve patients includes collecting, reviewing and reporting all Adverse Event information associated with the use of Amgen’s investigational or marketed products. An “Adverse Event” is any new, undesirable medical experience or change in an existing condition, which occurs during or after use of any marketed or investigational product. 

Every Amgen staff member must report any Adverse Event that he or she becomes aware of within one business day that:

• occurs in conjunction with Amgen product administration; and
• has not already been reported as part of a systematic adverse event data collection process, such as clinical trials, post-approval marketing programs, named patient programs, disease management programs, or surveys of patients or healthcare providers.

Possible sources of Adverse Event reports include, but are not limited to:

• Reports on marketed products provided to any Amgen staff member, consultant, contract worker or temporary staff from any source;
• Amgen sponsored clinical trials (pre and post-marketing trials);
• Amgen product external WEB page;
• Reports in medical literature;
• Reports from licensees of Amgen products (clinical trial and spontaneous, post-marketing reports);
• Reports from regulatory agencies; and
• Reports from other pharmaceutical manufacturers in which an Amgen product is co-suspect

All information that pertains to an Adverse Event must be directed to Amgen Global Safety for review and analysis as appropriate.