Pharmacovigilance service

Pharmacovigilance is the process of collecting, monitoring, researching and evaluating information from healthcare providers and patients for the purposes of understanding and preventing drug-related problems.

Oncopharm also committed to its foreign partners providing service of Pharmacovigilance for their registered products in Egyptian territory through Pharmacovigilance system of oncopharm,.

So it’s our responsibility to provide all Pharmacovigilance activities for the products of our partners in Egyptian market through.

1- Sharing the all relevant information collected from Egyptian market with both of the Egyptian Pharmacovigilance Center (EPVC) and Pharmacovigilance Center of marketing authorization holders.

2-sharing all relevant information received from marketing authorization holders to Egyptian Pharmacovigilance Center (EPVC).

The provided Pharmacovigilance activities include:

1. Collection of Adverse Events/Adverse Drug Reaction from Egyptian Heath community.
2. Delivery of Adverse Events/Adverse Drug Reaction to EPVC Egyptian Pharmaceutical Vigilance Center.
3. Follow up information on Adverse Events/Adverse Drug Reaction from Egyptian Heath community.
4. preparation local Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER) according to European Union Reference Dates(EURD) timeframes for Submission to EPVC Egyptian Pharmaceutical Vigilance Center.
5. Receiving the Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER) for the product from MAHS according to European Union Reference Dates (EURD) timeframes for Submission of Egyptian Pharmaceutical Vigilance Center EPVC.
6. Submission of Risk Management Plan and its variations received from the MAHS to Egyptian Pharmaceutical Vigilance Center EPVC.
7. Follow up with MAHS to receive and submit any requested variations in the Summary of Product Characteristics (SPC) and Patient Information Leaflets (PIL) to EPVC Egyptian Pharmaceutical Vigilance Center.
8. Submission of the received notifications with any change in reference data within 5 days form change from the MAHS to Egyptian Pharmaceutical Vigilance Center EPVC according to regulation.