Welcome to Pharma Whisper, a bi-weekly info-Blog that you’ll surely want to bookmark.
We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
Digitalisation – CDER’s NextGen Portal
The FDA is moving forward with digitalisation in all areas and the CDER NextGen Portal is a good example. What is the CDER NextGen portal? CDER’s NextGen Portal is a cloud based system for users to report information to the FDA. From Drug Development Tools (DDTs) to amendment submissions, stakeholders can utilise the NextGen Portal.…
eSTAR – FDA’s next move to go digital
On 10th January 2023 the FDA announced a joint eSTAR, the electronic Submission Template And Resource pilot together with Health Canada. This is another approach in digitalisation via harmonising submission formats, allowing originators to reuse data and documents in different regions. The pilot will test the use of a single eSTAR submitted to both the…
Article 57 xEVMPD to IDMP/SPOR – Automated Consistency Check
As stated in our previous blog, EMA’s webinar “DADI-PMS Webinar Agenda – ‘Variations Form for Human Medicinal Products – What will happen at Go-Live’” made it clear that data quality [in PMS] is dependent on xEVMPD. PMS, the Product Management Service out of the EMA SPOR project builds on the data foundations of the Referential…
Pharma Whisper 