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PV Agreement

Humans vary in their biological reactions to medicinal products. This is why not all adverse reactions (side effects) associated with the use of medicinal products can be detected during clinical development, not even by the most comprehensive clinical trials. Capturing as many of these adverse reactions, however rare they may be in absolute terms, from worldwide sources is of paramount importance for continued patient and drug safety (pharmacovigilance).

Pharmacovigilance takes center stage, beyond mere compliance with worldwide regulations. To provide up-to date safety information on products, your support is pivotal, whether you are a customer, patient or healthcare professional

The following World Health Organization statement is emblematic of this shared responsibility:

“To know of something that is harmful to another person, who does not know, and not telling, is unethical.”

(Ethics in Pharmacovigilance – WHO)

To report an adverse event (ADR) to ICA Foundation, please download the ADR Short Report Form for LNG IUS and return it completed to:

Bayer AG
Global Pharmacovigilance
Muellerstr. 178
D-13353 Berlin

Fax: +49 30 468 96765
E-mail: GPV.CaseProcessing@bayer.com

Please feel free to refer to, and use for training, the attached ADR Training Slides on basic pharmacovigilance which will guide you through the reporting process.

Basic Pharmacovigilance Training Slides (PDF)

ICA Foundation International Contraceptive Access - Provider Training Presentation (PDF)

Your valuable contribution to patient and drug safety is much appreciated – Thank you!

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