Newsletter | October 14, 2025

10.14.25 -- Innovations In IRT

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FEATURED EDITORIAL

EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?

The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025

INDUSTRY INSIGHTS

Fixing The Monitoring Model: Flexible Resources For Trial Success

Discover how flexible, site-focused monitoring strategies are transforming clinical trials by improving communication, enhancing compliance, and resolving challenges before they impact study success.

Risk Mitigation Planning For Pharmaceutical Tariffs

Examine the potential ramifications of proposed tariffs on the pharmaceutical and biotechnology sectors, highlighting critical concerns regarding national security and supply chain stability.

Making The Case For Case Management For Cell And Gene Therapies

It is crucial to ensure that CGT supply chain risks are mitigated, as well as to have proactive strategies in place to address unforeseen challenges before they become an issue.

SOLUTIONS

Innovations In IRT