Quality Systems

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Podcasts

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish 

Articles

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines. 

EMA Reviews Risks of CAR T-Cell Medicines and Painkillers

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

EMA’s CHMP recommended treatments for hemophilia A, colorectal cancer, hypertension, overactive bladder, and metastatic breast cancer.

EMA Recommends Eight Medicines for Approval in April

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

Videos

In this latest installment of the Europa Perspectives series, Alexander Natz, Secretary General at EUCOPE, delves into the European Commission’s new measures aimed at making lifecycle management more efficient across the European Union.

Europa Perspectives on Lifecycle Management

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

Filtration Clarification Needs in Annex 1

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

Europe's DARWIN EU Data Program Adds Capacity

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

Updating Swiss Regulatory Processes in 2024

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.

Regulatory/GMP Compliance, Europe