As of today, all clinical trials in the European Union (EU), including those that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical ...

The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" conference has been added to ResearchAndMarkets.com's offering. The Common ...

As pharmaceutical companies adopt AI technologies ... The preparation of the Common Technical Document (CTD), a mandatory component involving extensive data compilation for regulatory submissions ...

Indian pharma exudes confidence to sustain US market presence under President Trump’s regime: Nandita Vijayasimha, Bengaluru Thursday, January 23, 2025, 08:00 Hrs [IST] Indian p ...

Using glucocorticoids, rituzimab, or certain immunosuppressants to treat connective tissue diseases is associated with greater risks for severe COVID-19-related outcomes.

Participants enrolled in the study had a diagnosis within 12 months of study screening of symptomatic PAH (WHO Group 1, classified as FC II or III) and presentation of idiopathic or heritable PAH, PAH ...

Previous reports on CTD-PCP are limited to single-centre observational studies ... ST is generally administered at a lower dose in patients with renal dysfunction. Per the Japanese pharmaceutical ...

Since publication of the S1B Guideline, scientific advances toward elucidation of mechanisms of carcinogenicity, greater understanding of the limitations of rodent models, and several retrospective ...

Bryan O’Donnell, Head of Quality at Gaelic Laboratories, explains how to navigate GMP challenges to ensure your company ...

As the demand for novel therapies and personalized medicine surges, leaders are uniquely positioned to create a culture of creativity, collaboration and innovation.