Safety Scan – (International monitoring of Adverse Event reporting)
Keep your drug safety in Mind – SafetyScan by Mind Pharma
According to Pharmacist regulations (preparations) 1986, and Ministry of Health procedures, registration holders (MAH), must report adverse events and any new safety information.
Starting 2013, the Israeli Ministry of Health established a new Pharmacovigilance and Safety department and updated its Pharmacovigilance and drug surveillance SOP (#6) . Thus set new requirements that meet the highest international standards in line with EMA / FDA.
These new requirements demand, for registered drugs, the constant monitoring and reporting of all drug safety information in 24 recognized countries, on a regular basis.
The common question the industry faces is:
“Our company has many products, how are we going to find time to monitor all the drug safety data, on a regular basis?!”
Mind Pharma offers you SafetyScan, a unique, powerful service of scanning the international competent authority’s websites in 24 reference countries, extracting the most recent relevant information that you need.
Our clients receive a comprehensive customized report at a desired frequency (Regular basis / S.O.S reports).
This service allows our clients to focus on their core business goals and activities, and yet to becompliant with the most recent Ministry of Health regulations.
SafetyScan is a unique tool developed at Mind Pharma by a competent professional team of pharmacists and a medical doctor (physician).
SafetyScan is a reliable compliance tool and service for a safer compliance.
The Israeli Ministry of Health emphasizes the importance of keeping public safety and allows only safe, efficacious and high quality drugs reach the market.
Mind Pharma, managed by Shavit Fragman provides Appointed Pharmacist , Responsible Pharmacist – Qualified Person (QP) & batch release , Qualified Person Pharmacovigilance (QP-PV) and Medical Director services.
We also support establishing quality assurance system management, writing SOPs, audits, mock audits, quality and technical agreements.
Need more information? Contact us here.