by adminBenzi | Nov 5, 2024 | Events, News
On 2 and 3 November 2024, the first face-to-face meeting of the INVENTS Paediatric Patient Expert Group (PEG) titled “Innovative methodologies based on in silico models and the secondary use of health data” was held in Bari. Under the European INVENTS project, TEDDY network, partner of the project, has established a PEG to support the researchers participating in this EU project with their opinions and suggestions to improve the conditions of thousands of children... 
by adminBenzi | Oct 23, 2024 | News
The ICH E11A Guideline on paediatric extrapolation reached Step 5 on 21 August 2024, following the public consultation of its draft version in 2022. The primary aim of this guideline is to promote the international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines. To achieve this goal, the guideline provides a framework of recommendations for applying extrapolation in paediatric drug development. This... 
by adminBenzi | Oct 21, 2024 | News
On 19 October 2024 the World Medical Association (WMA) adopted the 10th revision of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Participants. This is likely the most significant revision of the Declaration since 2000, as it reflects a determined effort to adapt ethical standards to contemporary challenges in medical research. The major revisions focus on: • Participant-centred respect and protection: this includes... 
by adminBenzi | Oct 17, 2024 | News
The European Medicines Agency (EMA) has officially released its final "Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle" following a public consultation period. This paper explores the potential applications and regulatory considerations for AI across the lifecycle of medicinal products, from drug discovery and clinical trials to post-authorisation activities such as pharmacovigilance. Notably, the reflection paper... 
by adminBenzi | Oct 15, 2024 | News
This year's Nobel Prize in Medicine has been awarded to two American researchers: Dr. Victor Ambros and Dr. Gary Ruvkun, who discovered microRNAs (miRNAs), a new class of small RNA molecules that play a crucial role in gene regulation. Ambros and Ruvkun's discovery revealed a new principle of gene regulation that is fundamental to multicellular organisms, including humans. Now we know that the human genome contains more than a thousand miRNAs, which play an... 
by adminBenzi | Oct 11, 2024 | News
The European Commission has published a draft Regulation on Health Technology Assessment (HTA), focusing on joint scientific consultations for medicinal products for human use and how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product. This initiative aims to enhance collaboration between EU Member States to assess new health technologies and provide guidance to developers, facilitating... 
