24
Feb
AIFA stops all clinical trials that do not comply with the Clinical Trials Regulation on January 31, 2025
According to the EU Regulation on Clinical Trials (CTR), for the first 3 years from the application of the CTR, trials could be conducted in Europe according to the CTR or according to the previous legislation, depending on when the request for authorization to conduct the trial was submitted.
22
Nov 24
Medical research: Prior consultation with the Data Protection Authority is no longer required
Medical research is one of the areas most affected by rapid technological development and increased use of artificial intelligence (AI) systems.
21
Nov 24
Certifying digital procurement platforms (PADs)
Digital procurement platforms (“PADs”) are infrastructures used by contracting authorities for digital management of procurement in accordance with the provisions of the Public Procurement Code. They are necessary for digital execution of the entire lifecycle of public contracts and are an integral part of the Italian digital procurement ecosystem (e-procurement).
21
Nov 24
New AIFA guidelines on observational studies and decentralized clinical trials: Digital tools increasingly in focus
The AIFA issued two new guidelines, focusing, respectively, on observational studies and clinical trials for medicinal products.
21
Nov 24
New AIFA guidelines on simplification and decentralization of clinical trials
The AIFA approved guidelines concerning simplification and decentralization of clinical trials of medicines, on the same day as those on observational studies.
21
Nov 24
Transparency in clinical trials: Revised transparency rules take effect
The major changes under the revised transparency rules for the Clinical Trials Regulation and its Clinical Trials Information System, issued by the EMA in October 2023, should lead to faster publication of key documents (including protocols) and should make the system easier to use.
