DIETARY SUPPLEMENTS, THE CLINICAL TRIALS ROADMAP.

2022-07-05T13:37:51+00:00May 11th, 2022|Categories: Meditrial|Tags: , , , , , , , |

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.

2022-07-05T08:52:21+00:00May 4th, 2022|Categories: Meditrial|Tags: , , , , |

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 [...]

Sviluppo clinico di farmaci e dispositivi medici: una panoramica degli aspetti più innovativi e di maggiore interesse

2022-07-05T08:53:13+00:00May 4th, 2022|Categories: AboutPharma|

Nasce su AboutPharma Online, in Collaborazione con Meditrial, uno spazio per illustrare le nuove roadmap per lo sviluppo clinico e come prepararsi. Lo sviluppo clinico è un termine tradizionalmente utilizzato per definire l'intero processo di immissione sul [...]

PRAC Strategy on Measuring Pharmacovigilance Activities

2023-03-29T13:55:52+00:00April 22nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: , , , , |

In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the PRAC Impact Strategy integrates the achievements over a five-year period since its launch in [...]

The EUDAMED UDI/devices module updated technical documentation is available

2024-02-29T14:33:14+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|

The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]

EUDAMED UDI/devices Updated Technical Documentation Module

2023-03-29T14:01:39+00:00April 13th, 2022|Categories: Compliance, Europe, MDR|Tags: , , , , , , , , |

The European Commission published a series of new UDI device related documents. UDI/Devices User Guide for Economic Operators EUDAMED UDI/Device data dictionary V2.7 UDI Device Business rules v2.7 UDI Device enumerations v2.7 MDR and IVDR introduce an EU device [...]

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