From screening to reporting, read through our insights into pharmacovigilance collaboration and workﬂows.
Identifying risks is the most complicated and the most sensitive part of pharmacovigilance in general, including PSUR writing. Every risk has to be well-covered. There are layers upon layers to consider in risk assessment, and you need to approach it with special care. For some substances, they’re even harder to pin down than others.read more
The Literature section is one of the vital organs of PSURs. Most information you’ve accumulated plays a big part here. This is the section where you distill all the monitoring and screening you’ve done up to now and produce significant insights.read more
Literature monitoring is the backbone of all your PV reports. Their compliance depends on your skill to identify relevant literature. Many criteria determine a finding’s relevancy – so how can you recognize them efficiently?read more
Periodic Safety Update Reports require great precision and knowledge. A lot of organization and management goes into their composition. And you can achieve all that with good planning and preparation.read more
It would be an understatement to call Periodic Safety Update Report (PSUR) writing a challenge. Mounts of pressure lie on professionals who compose them. How can you keep excelling in such a strict and ever-changing regulatory environment?read more