Quality Assurance, Pharmacovigilance and Regulatory Affairs
for the Israeli Pharmaceutical and Medical Device Market
Regulatory compliance of Pharmaceutical and Medical Device Products in Israel
Marketing authorization holders of pharmaceutical and medical device products are required to comply with several regulatory obligations in order to get permission from the Israeli authorities to market their products.
These include a registration file approved by the Israeli Ministry of Health (IMOH), a quality management system based on GMP and GDP for medicines, and on ISO for medical devices, and a pharmacovigilance or medical device vigilace system.
Furthermore, professionals approved by the IMOH must lead these systems, including an appointed pharmacist for the registration and Regulatory Affairs activities, a QA manager, a Qualified Person (QP) for batch release and a Qualified Person for Pharmacovigilance (QPPV).
PharmaQR is supporting all these obligatory technical needs from A to Z, in order to enable companies to market their products in Israel.
About Us
~
PharmaQR was established and is led by Dr. Yaron Hassid who has served in key positions in the pharmaceutical and medical device industry including Head of Global Quality and Head of Global Pharmacovigilance.
While holding these positions Yaron acquired deep experience in establishment and management of local and global pharmaceutical systems and in handling successfully the challenges that characterize them.
During his years in the industry, Yaron served also as a QA manager, a Qualified Person (QP), a Qualified Person for Pharmacovigilance (QPPV) and as an appointed Pharmacist for Regulatory Affairs (RA).
Yaron holds with honor a B.Sc degree from the School of Pharmacy of the Hebrew University of Jerusalem, M.Sc in Microbiology from the Tel Aviv University and a Ph.D in Pharmacokinetics from the Weizmann Institute of Science.
The profound academic background and extensive practical experience of its leader enables PharmaQR to implement scientific and practical approach while handling the extensive QA, RA and PV tasks which characterize the Pharmaceutical and Medical Device industry .
Dr. Yaron Hassid
PharmaQR provides extensive QA services according to the relevant GMP/GDP/ISO guidelines.
The company is specialized in the establishment of high-level quality systems and in preparation to regulatory inspections, particularly GMP/ GDP inspections of the Israeli Ministry of Health (IMOH) and ISO 9001/13485 inspections of the Standards Institution of Israel.
Preparations are based on quality system evaluation, gap analysis, process analysis and writing of Standard Operating Procedures (SOPs) to cover the identified gaps.
PharmaQR also provides routine QA services such as change control, quality complaints handling, deviations, CAPAs and trainings for managers and employees on quality related issues.
Quality Assurance
Pharmacovigilance
PharmaQR supports its clients both in the establishment and maintenance of the pharmacovigilance structure and in the performance of the pharmacovigilance activities themselves.
The establishment and maintenance of the pharmacovigilance structure includes writing of the Pharmacovigilance System Master File (PSMF) and all the related SOPs.
The other pharmacovigilance support includes preparation/ review of periodic safety reports such as PSURs/PBRERs/ DSURs, Risk Management Plans (RMPs) writing and implementation, literature review for Adverse Events (AEs) identification and reporting, Regulatory Authorities sites follow up for identification of signals and reportable events, ICSR reporting, and Israeli QPPV coverage according to SOP 6 of the Israeli Ministry Of Health.
Qualified Person- QP
The Israeli legislation requires the Marketing Authorization Holder (MAH) to nominate a QP who is responsible for the quality of the product. The QP responsibilities include control on the manufacturer and on the supply chain of the medicine, and after ensuring the quality of each batch and its compliance with the registration file, the QP is responsible to release the product for sale in the Israeli market.
After the release, the QP responsibilities are not finalized since he should control the quality complaints received from the public and to manage product recalls if needed.
The long cooperation of our team members with manufacturers, MAHs, importers and particularly with the IMOH, enables us to provide QP services in a balanced way that ensures the quality of the products and at the same time avoids overdoing that may paralyze the activities of the Marketing Authorization Holder.
Registration and Regulatory Affairs Services
The appointed pharmacist is responsible for the contact between the Marketing Authorization Holder and the Israeli Ministry of health regarding the registration file and other subjects such as packaging materials, update of leaflets and publications.
PharmaQR provides RA and appointed Pharmacist services including registration of new files, renewals, variations submissions, packaging materials and publications
