highlights

EMA guidelines on investigational ATMPs

A development approach based on risk assessment will be an essential prerequisite for obtaining regulatory approval of ATMPs.

Digital Validation in pharma: efficiency and compliance

Digital validation is transforming pharmaceutical validation: it automates processes, integrates data, ensures compliance, and enhances operational efficiency. A necessary shift for Pharma 4.0 companies.

Bye bye resilience

Business

Genitourinary Tumor Study ongoing with Active Screening and Enrollment

Genenta announces Long-Term follow-up observations in brain tumor (GBM) study with emerging survival signals

CE marking for substance-based medical devices and drug-device combination products

BSI, full-scope Notified Body for all three types of devices pursuant to MDR and IVDR, is able to offer verification services for compliance with European directives about the production of medical devices

MAGAZINE

MakingPharmaIndustry | March 2025 | Issue 1

In the March multimedia magazine, we explore the impact of artificial intelligence and cybersecurity regulations in the pharmaceutical industry. As artificial intelligence reshapes drug development,...

MakingPharmaIndustry | The Magazine of the Pharma World | Issue 1_2025

This special issue explores the impact of automation and AI on pharmaceutical production—across GxP, sustainability, and digitalization.
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