Gaps exist in regulatory science that need to be addressed to improve medicine development and evaluation, ultimately to enable access to innovative medicines that address patients’ needs. The European Medicines Agency (EMA) has outlined approximately one hundred...
The European Medicines Agency (EMA) has launched a public consultation on the draft chapter dedicated to real-world data (RWD) within the Data Quality Framework for EU medicines regulation. This is essential for advancing the use of real-world evidence in regulatory...
Fondazione Gianni Benzi is delighted to announce that applications are now open for the Second-Level Master’s Programme in Regulatory Sciences - G. Benzi, organised by the Department of Biology and Biotechnology "Lazzaro Spallanzani" of the University of Pavia. This...
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...
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...
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...
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...
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...
In recent years, numerous medicines regulatory agencies have shown an increasing willingness to consider real-world evidence (RWE) to support claims of efficacy, effectiveness, and safety. RWE derived from the review and analysis of real-world data (RWD). This shift...
In May 2024, the International Council for Harmonisation (ICH) released the M14 guideline “ICH M14 Guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. This...
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