RPS R2 Iteration 2 - Updated Storyboards
Example of Submission Unit Point of Contact
For all new applications industry need to submit a pharmacovigilance system (how to collect, document and report side effects). Checking of this documentation will be done by the pharmacovigilance unit of the agency. Objections and responses from this specific area will be exchanged directly (contact not BfArM but Mrs Miller) although the process management contact person will remain the same, Mrs. Clark within BfArM. Another example: From agencies point of view we also need contact person details who will be the process manager or project team leader I need to contact regularly or in case of emergency.