Pharma­covigilance

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects associated with pharmaceutical products or any other medicine-related problems.

CTC’s Pharmacovigilance department has experience in investigational medicinal products (IMPs), advanced therapy medicinal products (ATMP) and medical devices in a wide range of indications and areas of use. The team carries out their work in accordance with EU Clinical Trials Regulation, guidelines for good pharmacovigilance practices (GVP) and other relevant regulations and directives.

The pharmacovigilance services encompass both clinical development and approved drugs and are built on 4 corner stones:

• Clinical Pharmacovigilance including Safety database
• Medical Monitoring
• Clinical Coding
• Post-marketing Pharmacovigilance

Every medicinal product and medical device must have completed a satisfactorily clinical trial/investigation program establishing acceptable evidence of safety and efficacy before achieving marketing approval or CE marking. The Pharmacovigilance team at CTC offers offer guidance and solutions that align with each customer’s unique requirements in terms of pharmacovigilance services, and the current phase of the lifecycle of a drug or medical device. Our safety management approach includes safety physician availability 24/7 (if needed), SAE/SUSAR handling- and reporting, annual safety report (ASR) writing and setup of a validated safety database. In-house medical monitors may act as the Sponsor’s safety representative and are free of conflict of interest in relation to the clinical trial. We tailor our services to provide suitable and reliable support to your team throughout the drug/device development process.

When a medicinal product reaches the marketing authorisation application/authorisation stage, additional activities are required such as the appointment of a qualified person responsible for pharmacovigilance (QPPV, EU and/or UK), setup of a related pharmacovigilance system master file (PSMF), regular literature searches, signal detection, management and reporting of individual case safety reports (ICSRs), authoring of standard operating procedures, risk management plans, aggregate reports, as well as handling of medical inquiries and product quality complaints. Our personnel are well trained and experienced in both EU and UK pharmacovigilance legislation and have a robust experience from the QPPV role and PV audits and inspections.

Read more about Medical Monitoring, Safety Management, Medical Coding, Safety Committees and Medical Device services within our Pharmacovigilance department.