Pharmacovigilance

The word pharmacovigilance is derived from the Greek pharmakon - drug, and the Latin vigilare - to be awake or alert, to keep watch. Pharmacovigilance spans the life cycle of a product and is the science of monitoring, researching and evaluating information from healthcare providers and patients on the adverse effects of medicines. This information is then used to identify potential new hazards and prevent harm to patients.

Our established and proven Pharmacovigilance system monitors risk, from the initial clinical trial phase all the way to post-marketing of the product. Recently new regulation has been implemented which affects the way in which patient safety research and evaluation is conducted. Examples of this are; the timeline for Periodic Safety Update Reports (PSURs) has been altered and all Adverse Drug Reaction reports now have to be submitted electronically. These changes in legislation can create a significant burden in terms of time, resources and expertise.

However, at TRAC our dynamic team are always fully trained and conversant with all current legislation ensuring that we can offer the best service as efficiently and accurately as possible. Our regulatory affairs consultants' position at the cutting edge of Pharmacovigilance legislation allows us to ease your company's burden in terms of time, resources and expertise.

Our Pharmacovigilance experts can offer a broad range of services which include:

• Preparation for Pharmacovigilance audits.
• Validated safety database (ARISg)
• Annual Safety Reports.
• Post-Approval safety reporting.
• Periodic Safety Update Reports (PSURs)
• Processing of AE reports from Clinical Trials/Post-Approval use.
• Monthly line listings.
• Risk Management Plans
• Medical safety reviews

For more information please download our brief guide to Pharmacovigilance. If you have any further questions regarding Pharmacovigilance please Contact Us or complete and submit an Enquiry Form.