Essential for healthcare: The importance of patient safety as a main topic

The Patient Safety Awareness Week will take place this year from 11 – 17 September 2023. Based on the WHO theme “Engaging patients for patient safety”, the joint slogan of the D-A-CH countries is: “More safety. For patients. With patients.

How are we supporting patient safety at Medinova?

For Medinova it is of utmost importance to ensure the quality, safety, and efficacy of all our products. To achieve this Medinova complies with the pertinent regulations, adhering to the highest quality control and quality assurance standards and using  continuous improvement processes. In addition, Medinova continuously invests in clinical studies to prove the efficacy and safety of our products, and organizes Webinars aimed to provide patients and health care professionals up to date information on a broad range of topics related to the indications of our products.

Why is this important?

Defective drugs could result in a lack of efficacy, adverse effects, or be even outright dangerous, becoming a risk to public health. This is why it is so important to have appropriate quality controls and to have a system that assures the correction of problems when they arise, and the prevention of future occurrences.  Pharmacovigilance collects all the side effects reported worldwide

 to identify potential problems and address them appropriately.  The webinars organized by Medinova provide information on the disease, treatments and how to use our products according to their approved indications. Medinova works in close contact with KOLs and patient organizations, to understand their needs and provide effective solutions to unsolved clinical problems.

What are the legal guidelines?

In Europe, the EU pharmaceutical legislation (Directive 2001/83 and Regulation 726/2004) has enabled the authorization of safe, effective and high-quality medicinal products. In April 2023, the European Commission presented a draft for a comprehensive reform of the pharmaceutical legislation intended to promote innovation and improved access to medicines.  Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are the minimum standards a manufacturer must meet in their production process, and a wholesale distributor must meet to ensure the quality and integrity of medicines are maintained throughout the supply chain. Good Pharmacovigilance Practice (GVP) describe the pharmacovigilance process in the European Union, i.e. the totality of measures for the detection, recording, evaluation and prevention of side effects and other drug-related problems that may occur during the use of drugs. Beyond the legal requirements, Medinova is committed to transparent communication with other pharmaceutical companies through its voluntary participation in the so-called Pharma Code, which ultimately aims to increase patient safety.

Where or how should I as a patient report an adverse event?

If you observe any side effects, talk to your doctor or pharmacist, who will report these via the national reporting system. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

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