Edited by Dr. Monica Tocchi, Meditrial medical director. The organization called ICH (International council for harmonization of technical requirements for pharmaceuticals for human use) is a global organization that unites regulatory authorities and the pharmaceutical industry in the common [...]
Atty. Alessia Nuciari, director of compliance Meditrial. The in vitro diagnostics industry has undergone a substantial transformation. IVDR Regulation 746/2017, published in May 2017 and applied from May 26, 2022, introduced major changes in the industry. The main [...]
Dr. Paola Antonini, Meditrial scientific director. If well designed, observational studies and registries produce treatment effect data comparable in importance to those in randomized controlled trials, generating information missing in traditional interventional studies and real-world data to support marketing [...]
Research and innovation are based on rigorous clinical trials involving patients firsthand. The main actor in clinical trials is the patient affected by the disease under examination. Including the patient’s perspective allows us to reduce barriers that otherwise limit your [...]
The challenge of recruiting suitable patients into clinical trials has always been a significant obstacle to drug and medical device development programs. The difficulty of generating evidence delays the introduction of new medical interventions and results in high costs. [...]
Paola Antonini, Meditrial Scientific Director. Due to the pandemic and the information shared on social media, the increased attention of individuals to their own health and well-being has led to a considerable increase in the consumption of food supplements [...]
CLINICAL DEVELOPMENT OF DRUGS AND MEDICAL DEVICES: AN OVERVIEW OF THE MOST INNOVATIVE AND INTERESTING ASPECTS.
Clinical development is a term traditionally used to define the entire process of bringing a new drug or medical device to market. It includes a pre-clinical phase to support human use and a clinical trial phase on patients, in compliance [...]