In GMG, we fully understand the importance of Pharmacovigilance and have developed SOPs to properly and timely recording adverse drug reactions and drug complaints, as well as promoting them to the competent bodies. In addition, the staff of the company in contact with patients is regularly trained on the nature and procedures of Pharmacovigilance. It is important to note that the registration and promotion of each AE is handled by a specific procedure by the partners to the GMG Pharmacovigilance Department within 6 hours of the time of the initial recording.
Pharmacovigilance (WHO), as defined by the World Health Organization, is: science and activities related to the detection, evaluation, understanding and prevention of adverse drug reactions and other drug-related problems.
The basic principle of the HF is the Hippocratic benefit or non-harm, and its continuous goal is to safeguard and promote Public Health through continuous monitoring of the safety data of marketed pharmaceuticals, thus ensuring the patients’ right to safe and effective Medicines. At the same time, the IB contributes to the enrichment of knowledge about adverse drug reactions and takes appropriate measures for their better and safer use. It constantly monitors the risk-benefit balance of pharmaceuticals, ensuring that it always remains positive for the benefit.
Diagram flow of pharmacovigilance procedures
- The information for each RU is forwarded to GMG’s GM department within 6 hours of recording (Time 0)
- Pharmacovigilance (PI) / Adverse Reaction (AE) Information (Initial)
- Case evaluation by GMG’s QPPV
- Report AE to the contracted partner (eg pharmaceutical company)
- Ensuring the quality of data transcription
- Promote reference AE to the contracted partner within 24 hours
- Further communication with the contracted partner on the basis of contractual obligations
- A GM reference classification in the GMG AI file
- Reconciliation and duplicate identification with contracted partners at agreed intervals