Newsletter no. 22 - September 2023

HIGHLIGHTS

NEW FRONTIERS RESEARCH TOPIC: REPURPOSING FOR SMALL POPULATION NEEDS

A new research topic on Frontiers in Medicine Regulatory Science journal has been published! It is dedicated to repurposing medicines to cover unmet therapeutic needs for small populations, like paediatric and rare disease patients. Viviana Giannuzzi, from Fondazione Gianni Benzi, is one of the co-editors.

Submission deadline for abstracts is 31 October 2023 and for manuscripts 29 February 2024.

Manuscripts as original research, review, mini review, policy and practice review, hypothesis and theory, perspective, clinical trial, case report, policy brief, brief research report, general commentary, opinion, on the developments, applications, and policies on repurposing for small populations will be considered.

ACROSS THE WORLD

Updates and latest news across the world

PROMIS WEBINARS FOR LIFE SCIENCES – 11 & 17 OCTOBER 2023

Centro di Riferimento Oncologico – CRO in Aviano and 6 partners across Italy will organise and host a two-day event (11 and 17 October 2023), focused on the sharing of experiences within networks and initiatives dealing with Technology Transfer on the one hand and Health Technology Assessment and Innovation Procurement on the other. These are three key topics in the innovation process and involve several stakeholders from healthcare settings. They have common features such as the interaction with private stakeholders and the market that is boosted by clinical needs to be addressed at different levels.

Upcoming webinars: TECH TRANSFER MEETS HTA AND INNOVATION PROCUREMENT - Oct 11 and 17

Register for the event

DARWIN EU OPEN CALL FOR EXPRESSION OF INTEREST FOR NEW DATA PARTNERS

The European Medicines Agency (EMA) is looking for new data partners to collaborate with DARWIN EU® - the Data Analysis and Real-World Interrogation Network.

Public or private institutions that have access to real-world healthcare data can submit an expression of interest to become a potential new data partner in DARWIN EU®. The data will be used for studies to generate real-world evidence that will support scientific evaluations and regulatory decision making on medicines in Europe.

Deadline for expression of interest is 31 October 2023.

EMA REFLECTION PAPER ON THE USE OF ARTIFICIAL INTELLIGENCE IN THE LIFECYCLE OF MEDICINES

EMA has published a draft reflection paper on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. It reflects on principles relevant to the application of AI and machine learning (ML) at any step of the medicines lifecycle, from drug discovery to the post-authorisation setting. A public consultation on the draft reflection paper is now open until 31 December 2023 to collect feedback from all stakeholders and to identify opportunities and risks of AI in the field of medicines.

EC ADEQUACY DECISION: EU-US DATA PRIVACY FRAMEWORK

The European Commission adopted its Implementing Decision on the adequate level of protection of personal data under the EU-US Data Privacy Framework (Adequacy Decision).

Particularly, the Commission decided that the United States (US), for the purpose of Article 45 of the General Data Protection Regulation (EU) 2016/679 (GDPR), ensures an adequate level of protection for personal data transferred from Europe to organisations in the US that are included in the ‘Data Privacy Framework List’. Therefore, transfers from Europe to organisations in the US that are included in the Data Privacy Framework List may be based on the Adequacy Decision, without the need to rely on Article 46 GDPR transfer tools.

Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus

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