e.alvarado2022-07-05T08:43:00+00:00June 1st, 2022|Categories: Meditrial|Tags: Authorized European Representative, Authorized Representative, Device Vigilance, Incident, MDV, MEDICAL DEVICE VIGILANCE, Medical Devices, UNDERREPORTING|
Italy has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics. As of Oct. 16, 2022, the new rules [...]
e.alvarado2022-07-05T08:45:12+00:00May 25th, 2022|Categories: Meditrial|Tags: Clinical Trial, DECENTRALIZED STUDIES, PATIENT RECRUITMENT, RETENTION CHALLENGES|
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. [...]
e.alvarado2022-07-05T08:49:15+00:00May 17th, 2022|Categories: Meditrial|Tags: Clinical Trial, Covid-19 vaccines, Drug Safety, Eudamed, PAES, PASS, POST-AUTHORIZATION STUDIES, SAFETY|
Over the course of two years of the pandemic, there have been heated debates about the safety and efficacy of the anti-Covid-19 vaccines. Even today, after more than 7 billion doses administered, issues continue to emerge about the available clinical [...]
e.alvarado2022-07-05T13:37:51+00:00May 11th, 2022|Categories: Meditrial|Tags: Clinical Development, Clinical Trial, DIETARY SUPPLEMENTS, Food supplements, Functional foods, HOMEOSTASIS, NUTRACEUTICAL, Regulation 1924/2006|
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 [...]
e.alvarado2022-07-05T08:52:21+00:00May 4th, 2022|Categories: Meditrial|Tags: Clinical Development, Clinical Trial, DRUGS, Medical Devices, Pharmaceuticals|
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 [...]
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