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New ZLG Document on Transport Verification Published At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) […]
How CROs Can Support Pharmacovigilance and Regulatory Compliance? Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse reactions or any other problems related to medicines. It is an essential part of drug development and post-marketing surveillance, as it ensures […]
DCTs are not a fad, but a trend that is transforming clinical research and patient care. By leveraging technology to make trials more accessible
involving patients directly in pharmacovigilance efforts can be a game-changer. Patient engagement offers unique insights, enhances reporting systems, and fosters a collaborative approach to drug safety.
As healthcare advances, new treatment modalities, personalized medicines, and innovative technologies are reshaping the landscape.
Welcome to the latest edition of our Pharma News and Regulatory News Updates, where we bring you the most significant developments and breakthroughs in the pharmaceutical industry and the latest updates from regulatory agencies worldwide. These highlights from July 1st, […]
Pharmacovigilance guidelines serve as essential frameworks and standards that govern the practice of pharmacovigilance globally. These guidelines provide guidance and recommendations for various stakeholders involved in drug safety monitoring, including regulatory authorities, pharmaceutical companies, healthcare professionals, and researchers. Here is […]
Clinical trials happen in several phases during which different questions are asked.
Each phase builds on the results of previous phases
ADRs refer to harmful or unintended reactions caused by the use of medications or medical treatments. They range from mild side effects to severe and life-threatening events