Pharmaco/vigilance
Pharmacovigilance system
for medicinal products
Pharmacovigilance plays a crucial role in registration and sale of medicinal products. It is a critical infrastructure that enables detection and prevention of adverse drug reactions and early warning of potential risks. Effective pharmacovigilance practices of a pharmaceutical company contribute to its long-term business sustainability that allows strenghtening its market position and becoming a stable partner for patients.
Concerning all key pharmacovigilance activities, we can:
- Provide EU QPPV & Deputy, Local contact person
- Create, regularly update and optimize the PSMF
- Create and rationalise processes and controlled documentation including evaluation of the suitability of implementing automated systems
- Create and maintain a risk management and elimination plan
- Communicate with regulators
- Provide local and international literature screening
- Provide periodic safety&clinical practice reporting
- Perform training
- Perform pharmacovigilance audits
All documentation can be processed in Czech, Slovak or English according to your reqirements.
Vigilance system
for medical devices
Following the implementation of the MDR (EU Regulation 2017/745), the importance of MD vigilance has increased. For our partners, we offer comprehensive assistance in setting up and maintaining or even a full provision of a vigilance system. For vigilance requirements performance, especially in analysis processes, you can use our team of experts (physicians with more than ten years of experience in the fields of: cardiology, pain management, nephrology, pulmonary, diabetology, ophthalmology, dermatology).
Concerning all key vigilance activities, we can:
- Help with technical documentation in the risk management part (from the point of view of healthcare proffesionals - nurse and physician), especially in the areas of cardiology, pain management, nephrology, pulmonary, diabetology, ophthalmology, dermatology.
Create, update and optimize the post-market clinical follow-up (PMCF) system
Develop a post-market surveillance plan
Prepare post-market surveillance report
Provide regular update of safety report
Ensure reporting of serious adverse events and field safety corrective actions
Provide trend reporting
Provide analysis of serious adverse events and field safety corrective actions
Provide analysis of vigilance data
Create and rationalise your controlled documentation
Communicate with regulators
All documentation can be processed in Czech, Slovak or English according to your requirements.
Ivana Kodatová, M.D.
I have been working in the field of drug safety for almost 20 years. I have set up pharmacovigilance systems for original and generic medicines, including opiates, innovative medicines and radiopharmaceuticals. In the field of medical devices, I specialize in setting up vigilance for class III devices, especially those devices that include a medicinal product.