Barrco Regulatory Solutions provide vigilance services to your products. We provide Pharmacovigilance, Cosmetovigilance and Devicevigilance services to our manufacturers. Manufacturers and importers are required to monitor daily any safety information, adverse reactions or inefficiency brought to their knowledge, which occurred in importer’s country and are related to their registered medicines. Cosmetics and devices and medicines used for clinical research (clinical supplies).

Drug safety monitoring field, called Pharmacovigilance, is of critical importance to the caregiving staff, to the end user (the patient) and to the public. The legislation is based on the European regulation guidelines on Good Pharmacovigilance Practices (GVP) and the Qualified Person responsible for Pharmacovigilance (QPPV), of any new information regarding a registered medicinal product.

It is important to remember that the Health Authorities is able to impose sanctions on registration holders who breach the requirements of the law and relevant procedures in the field of side effects reporting – Pharmacovigilance (PV). Barrco Regulatory Solutions is involved in the field of the adverse reactions and new safety information reporting, and is in close and direct contact with all the relevant parties: The Health Authorities, the MAH, the manufacturer, medical staff (doctors, pharmacists, nurses), medical and academic institutions. Our extensive knowledge of vigilance services, together with our aspirations for excellence and desire to meet your standards, leads us to a complete control of this complex field, which has lately undergone significant changes.

We wish to assist you in this field, whether concerning prescription medicine, OTC, GSL, medical equipment, human and veterinary medications, or whether concerning medications or medical devices that are registered/marketed or during clinical trials. Barrco provides a comprehensive answer to the regulatory requirements in the field of Pharmacovigilance in a focused professional manner and in accordance with the defined schedule.

MAHs are required to report to the Risk Management and Drug Information Department at the Health Authorities in many cases regarding, among others:
– A side effect with abnormal incidence
– A side effect or lack of efficacy observed after drug’s formulation change
– Any serious or non-serious side effect that occurred in Israel
– Any information that has possible implications on product safety
– A restriction, alert or prohibition related to a safety problem (existing or potential) determined by a health authority of a recognized country regarding use of the medicine
– Notice to the healthcare professionals or to the public issued outside of Israel regarding the safety/ efficacy and/or use of the medicine
– New information published in the local and international medical literature related to drug’s safety.
– Submit PSUR (periodic safety update report) or PBRER (periodic benefit-risk evaluation report) to the Health Authorities.
– Submit DSUR (development safety update report) to the Health Authorities.
– Submit Monthly signal report to the Health Authorities.

The Health Authorities has strict requirements regarding the reporting method, timelines and contents of the report. The MAH is obligated to submit follow up reports for reported serious adverse events as well as for any additional reports upon request.

Regarding medical devices, there is an obligation to report:
– An action taken by a health authority in the world or a notice from the overseas manufacturer, the MAH or a health authority in the world
– Harm caused to the physical or mental health of a patient, or fear that such harm was caused by use of the medical equipment.
– Serious malfunction of the medical equipment

Our Services in the Field of Side Effects and New Safety Information Reporting. It is important to us that both parties, the MAH / importer and the Health Authorities, know that the field of Pharmacovigilance is in good hands in order to protect the public health. To ensure professional treatment and service, our professional team undergoes training and is well aware of the heavy responsibility lying on its shoulders.

Our pharmacovigilance team has long standing industry experience and consistently deliver, high quality and compliant Pharmacovigilance services:
– Long or short-term fulfillment of the role of Qualified Person responsible for Pharmacovigilance (QPPV).
– Safety reports writing
– Safety reporting to deferent health authorities
– Good Vigilance Practice (GVP)
– Product safety profile building
– Product safety profile continuous update
– Annual safety reports
– Medical literature screening
– Health authority PV database monitoring
– contract services for PV responsible personals worldwide
– Receipt, processing, evaluating and distributing of safety cases
– Review of periodic PSUR/PBRER and annual DSUR safety reports prior to submission to the Health Authorities.
– Professional literature review, specific for recognition of safety reports
– Preparation of a local Pharmacovigilance master file
– Assessment of your organization’s Pharmacovigilance system (audit)
– Training and qualification for the QPPV position
– World-wide tracking for safety signals
– Risk management due to use of medicines, risk/benefit assessment.

We provide end-to-end global pharmacovigilance services for pharma, medical devices, nutraceuticals and cosmetic companies worldwide in order to optimize the products’ benefit-risk profile to improve safety and achieve better patient outcomes.