Y-mAbs take patient safety very seriously, and it is vital for us to continuously monitor the safety of our products. Hearing about your experiences helps us to ensure the safety of our products and to offer the best possible advice to those using Y-mAbs products.
How to Report a Possible Side Effect
Please contact us at 1-833-33YMABS (1-833-339-6227).
Reports can be made directly to FDA as well at www.fda.gov/medwatch or 1-800-FDA-1088 (1-800-332-1088).
To help us process your report effectively, please report as much relevant information as possible. Please ensure to include the following minimum information:
About the Person Submitting the Information:
About the Person Who Experienced the Adverse Event:
About the Drug and the Adverse Event:
If you have any questions about your own or relative’s treatment or health condition, kindly contact your treating physician or the health care system.
At Y-mAbs we are committed to ensure patient safety
In patient safety, we are dedicated to the detection, assessment, understanding and management of adverse effects. We continuously monitor the safety profile of our products and ensure appropriate communication of safety information to health care professionals, patients, and regulatory agencies.
To live up to our responsibilities and safeguard patient safety, the following Y-mAbs functions/role have been established.
Safety Evaluation & Risk Management
This function manages a global system for the collection, review and reporting of adverse experience reports and other safety data received from worldwide clinical trials ensuring compliance with regulatory requirements.
Global Pharmacovigilance
This function manages a global system for the collection, review and reporting of adverse experience reports received from marketed products and the continuous assessment of product safety.
Chief Medical Officer
Our company’s chief medical officer holds overall responsibility for the benefit/risk of our pipeline and marketed products, provides medical oversight for all clinical programs, supervises the development and implementation of medical policies, including those related to data transparency and the sharing of clinical data, and has responsibility for the design of pre-registration expanded access (“compassionate use”) programs.
