Reuse of personal data for research purposes in light of the most recent guidelines from the Garante
In the context of clinical studies, companies are concerned about the legal conditions for use for research purposes of previously collected personal data, including data from third parties.
Draft EMA guidelines on transparency in clinical trials: Protecting commercially confidential information
On April 7, 2022, the EMA published draft guidelines on the transparency of information uploaded to the Clinical Trial Information System for the specific purpose of giving operational guidance on the management of commercially confidential information and personal data
Clinical trials and pharmacovigilance: Spanish Code of Conduct leads the way in data management
In an effort to expand the regulatory framework with self-regulatory instruments, the Spanish Data Protection Authority recently approved a “Code of conduct for the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance” supported by Farmaindustria, the national trade association for the pharmaceutical industry in Spain.
The new decree on non-profit studies: Data and results may now be sold
On February 16, 2022, more than two years later than planned, the Ministerial Decree of November 30, 2021, containing measures to facilitate and support the development of nonprofit clinical trials of medicinal products and observational studies, as well as to regulate the transfer of data and results of nonprofit trials for registration purposes, was finally published in the Official Gazette.
The role of the DPO in the public sector: New guidance from the Italian Data Protection Authority
On May 24, 2021, the Italian Data Protection Authority published on its website “Guidance on designation, position and tasks of the Data Protection Officer in the public sector”.
EU regulations on medical devices and the GDPR: first step forward a necessary coordination
In the wake of application of the European medical device regulation (EU Regulation No. 745 of 2017), occurred on May 26, Italy is taking its first steps toward adjusting its national regulatory framework.