(Pharmaco-)Vigilance

Pharmacovigilance

Pharmacovigilance systems are designed to ensure the safety monitoring of drugs during clinical trials and after marketing authorisation.

The aim is to identify, assess and understand adverse effects to allow for corresponding risk minimisation measures to be taken. Pharmacovigilance serves to record production errors or defective packaging and to prevent treatment errors and convey information about a medicinal product.

Because medicinal products can only be tested in a relatively small number of individuals – who may not represent the average patient – until they are approved, and since negative interactions with other drugs cannot be fully identified yet, a good pharmacovigilance system is required in practice to ensure that a medicinal product has a positive benefit-risk ratio.

Take advantage of the many years of experience of our pharmacovigilance experts: We will gladly take care of any and all reports to the authorities and ethics committees within the given deadlines.

Together with our experienced partners, MEDICRO GmbH offers you a comprehensive range of services to ensure your vigilance compliance:

• Evaluation, appraisal and implementation of your pharmacovigilance system
• Development of a risk management plan (RMP)
• Creation of Periodic Safety Update Reports (PSURs)
• Support during audits and inspections by authorities
• Employee training

Vigilance system for medical devices

The use of a vigilance system for medical devices in clinical trials ensures ongoing safety monitoring of the study subjects and, where applicable, of uninvolved persons. Owing to ever-increasing requirements, medical device manufacturers are faced with major challenges. The new Medical Device Regulation (MDR) of the EU in particular has resulted in far-reaching changes for medical device manufacturers.

The medical device vigilance system covers all levels of market observation: monitoring of incidents, a new risk assessment, reporting to the authorities and, where applicable, recalls. This ensures an adequate level of protection for patients, users and third parties.

Medical device manufacturers are under obligation to monitor the safety of their products by means of an appropriate vigilance system. Together with our experienced partners, MEDICRO GmbH offers you a comprehensive range of services to ensure your vigilance compliance. We will support you not only in the risk management process, but also in the implementation of the new “Medical Device Regulation (MDR)” to obtain or extend your CE mark.

Take advantage of the many years of experience of our vigilance experts: Together, we will find an efficient solution for implementing or optimising your vigilance system!

• Evaluation, appraisal and implementation of your vigilance system
• Market observation
• Creation of safety reports
• Reports to authorities
• Support during audits and inspections by authorities
• Corrective and preventive actions (CAPA)
• Employee training