21: Navigating a complex global regulatory environment to bring medicinal products to market
The pharmaceutical industry has been globalizing for many years as demand for medicinal products grows and as companies look to expand into the large and increasingly prosperous emerging markets. The ...
18 Heinä 202313min
20: Safety Reporting Requirements for Marketing in the EU
For US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. T...
6 Heinä 202320min
19: The important role of AI in TMF oversight
Artificial intelligence is playing an increasingly important role in document management in the life sciences industry and in particular in improving management and oversight of the Trial Master File ...
24 Touko 202312min
18: Tackling performance requirements in the more prescriptive world of IVDR
Summary: IVD manufacturers must perform two types of performance studies, clinical performance and analytical performance, in order to provide evidence that the device is safe and performs as intended...
5 Huhti 202313min
17: Gaining efficiencies with custom statistical solutions in a GxP setting
Summary: A lot of statistical work within pharmaceutical companies is repetitive and this costs money and resources, especially if it’s done within GxP environments where there is often a need for dou...
15 Maalis 202313min
16: How the quality culture impacts GMP activity
A strong quality culture in the biopharmaceutical industry is one in which all participants in the organization understand patient safety and how their roles impact patient safety risks. It is one whe...
22 Helmi 202321min
15: Managing the medical device pre-submission process with the FDA
There are unique considerations and nuances to the US Food and Drug Administration’s (FDA) pre-submission process for medical devices that companies need to consider. Known as the Q-submission (Q-sub)...
17 Tammi 202314min
14: Digitalization as a tool in the outsourcing journey
With pharmaceutical companies increasingly turning to outsourcing partners to support maintenance of marketed products, efficiency and reliability are imperative. Digitalization, in particular automat...
9 Tammi 202312min
