International – Cell and gene therapy : Regulatory Focus, July issue

Feature articles during July focused on global regulatory strategy for cell and gene therapy, with articles on US and EU regulations and guidances and...

International – Advanced therapies: ‘Trip hazards’ on the development pathway

This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call...

International – Global regulators agree on endpoints for COVID-19 therapeutics

Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary...

International – Coronavirus : la pandémie dope le trafic de produits pharmaceutiques

Antalgiques, corticoïdes, anesthésiants mais aussi masques, gants, lunettes, thermomètres : près de 20 millions de produits pharmaceutiques de contrebande ont été saisis depuis février au Moyen-Orient et...

Russia – AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface

Last week, Western intelligence officials pegged Russian hackers with an attempt to rip off leading research for a COVID-19 vaccine, linking the would-be thieves...

International – Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national...

International – The top 15 pharma companies by 2026 sales

As the pharma industry enters a new decade, the world's largest drug companies are busy launching new meds, restructuring to focus on innovative offerings...

International – Six Guiding Principles for Pharmaceutical Companies to Achieve Global Quality

Globalizing any technical function is a daunting proposition, so here I share a blueprint for successfully globalizing quality: six guiding principles distilled from decades...
ANVISA will implement new rules for medical device modifications in Brazil

International – Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil

The normative acts referred to below are any decisions enacted by ANVISA establishing norms, rules, standards or obligations. These include, among others, Resolutions, Norms, Normative Instructions,...

International – Nations raise concerns about access to remdesivir

Earlier this week (June 29), the US Department of Health and Human Services (HHS) announced a purchase agreement with Gilead for remdesivir. HHS said they...

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