Shape Program - Late stage research - between filing and approval
Challenge
Solution
Monitoring activities
| Pre-Approval Study | Peri-Approval Study (PAS) |
| - pre-study visits | - no pre-study visit |
| - investigator meeting | - either investigator meeting |
| - study initiation visits | - or study initiation visits |
| - regular routine monitoring visits | - 1 routine monitoring visit |
| - mandatory study close-out visit | - optional study close-out visit |
| Such studies further define safety, effectiveness and value of products. They help to find out whether substances are cost effective, in which patient population they work best and not to forget "how they behave in the real world". |