Regulatory and Standard Setting Organizations

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

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

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and help prevent drug shortages.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.

Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.