International – ICH adopts guidelines on viral safety evaluation and analytical method development
The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as...
International – WHO proposes best practices for clinical trials
The World Health Organization (WHO) has issued a draft guidance spelling out some of the important scientific and ethical considerations for well-designed clinical trials....
International – Expert review shows AstraZeneca’s COVID-19 vaccine is ‘equally effective’ as mRNA vaccines
Infectious disease experts from Asia reviewed data from the VIEW-hub database on vaccine use and impact, developed by John Hopkins Bloomberg School of Public...
International – ICH paper calls for ‘stepwise’ harmonization of RWE
The International Council for Harmonisation (ICH) issued a Reflection Paper outlining a “stepwise” approach to harmonization of real-world data and evidence (RWD/RWE) that includes...
International – The WHO anatomical therapeutic chemical/defined daily dose toolkit
This article provides a high-level overview of the anatomical therapeutic chemical/defined daily dose (ATC/DDD) toolkit developed by the World Health Organization (WHO) for drug...
International – ICH : Clinical Electronic Structured Harmonised Protocol (CESHARP) M11
The clinical protocol describes the processes and procedures directing the conduct and analysis of a clinical trial of medicinal product(s) in humans. To date,...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
International – Bébé-Crispr : la modification du génome d’embryon bute sur des obstacles techniques
Une décennie après son déferlement dans les laboratoires, l’outil de modification du génome Crispr-Cas9 alimente toujours une révolution scientifique et médicale et continue de...
International – WHO releases key regulatory considerations on AI for health
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
International – Pfizer doses first patients with mRNA-based influenza vaccine
Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically offer only 40% to 60% protection, with...
