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Arvatera Pharma operates with a commitment to ethical values, a science-focused approach, innovation, and a dedication to human health.
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PHARMACOVIGILANCE

WHAT IS PHARMACOVIGILANCE?

Pharmacovigilance activities are based on the systematic monitoring of adverse reactions and the benefit/risk balance to ensure the safe use of medicines, the collection, recording, evaluation, and archiving of related information, establishing communication among stakeholders, and taking the necessary measures to minimize the harm that medicines may cause.

 

The activities carried out for this purpose
can be listed as follows:

 

Monitoring the official websites of global health authorities to follow safety warnings related to medicines, reviewing safety applications submitted by marketing authorization holders, conducting benefit/risk assessments based on these data, and implementing the necessary measures to minimize risks for licensed medicines or those under license application in our country.

Reviewing Risk Management Plans (RMPs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) and taking the necessary measures.

Creating the list of medicines subject to additional monitoring.

Publishing Direct Healthcare Professional Communications (DHPCs).

Reviewing Risk Management Plans (RMPs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) and taking the necessary measures.

Creating the list of medicines subject to additional monitoring.

Publishing Direct Healthcare Professional Communications (DHPCs).

Taking necessary measures to encourage spontaneous reporting by healthcare professionalsto ensure the effective operation of the Pharmacovigilance system.

Organizing training programs on pharmacovigilance for healthcare professionals.

Informing marketing authorization holders and relevant international organizations about the measures taken.

Working in coordination with Scientific Advisory Boards when necessary and ensuring cooperation and coordination with other departments.

 
 

For more information:

By reporting the side effects you experience, you will contribute to gaining more knowledge about the safety of the medicine you are using.

Website:

https://www.titck.gov.tr/

E-Mail:

ebsyardim@titck.gov.tr

Phone:

44 44 680

 

Adverse Reaction Reporting Form

For reporting a side effect / adverse reaction, please fill out the TÜFAM reporting form and send it to info@arvatera.com.tr.