Assess whether to resubmit, meet, or pause the program after an inspector

SITUATION In a company with a CMC site change mid-review, an inspector asking for batch records you cannot produce this week put RWE protocol that may not meet regulator expectations in play. RWE evidence-strategy director should decide whether to resubmit, meet, or pause the program without filling gaps RWE protocol that may not meet regulator expectations does not contain.

DECISION RWE evidence-strategy director in a company with a CMC site change mid-review must choose To resubmit, meet, / Pause the program using RWE protocol that may not meet regulator expectations after an inspector asking for batch records you cannot produce this week.

HYPOTHESES TO TEST 1. An inspector asking for batch records you cannot produce this week is noise around an already-controlled Clinical and Evidence Strategy process in a company with a CMC site change mid-review, given RWE protocol that may not meet regulator expectations. 2. An inspector asking for batch records you cannot produce this week is the event in RWE protocol that may not meet regulator expectations that forces To resubmit, meet, for RWE evidence-strategy director under Pharma & Life Sciences. 3. RWE protocol that may not meet regulator expectations shows a one-file miss after an inspector asking for batch records you cannot produce this week, not a Clinical and Evidence Strategy program failure. 4. RWE protocol that may not meet regulator expectations cannot decide to resubmit, meet, or yet after an inspector asking for batch records you cannot produce this week; hold is the only Pharma & Life Sciences close a company with a CMC site change mid-review can defend.

ANALYSIS REQUIRED 1. Separate an isolated adverse event from a systemic quality issue. 2. Test a protocol deviation versus a safety signal versus a filing gap on to resubmit, meet, or. 3. Check whether RWE protocol that may not meet regulator expectations supports the labeled claim RWE evidence-strategy director would keep. 4. For this Pharma & Life Sciences Clinical and Evidence Strategy file, read RWE protocol that may not meet regulator expectations against an inspector asking for batch records you cannot produce this week and write the one fact that would move to resubmit, meet, or for RWE evidence-strategy director.

RECOMMENDATION Choose To resubmit, meet, / Pause the program on this Pharma & Life Sciences / Clinical and Evidence Strategy packet (RWE protocol that may not meet regulator expectations after an inspector asking for batch records you cannot produce this week). The follow-on Clinical and Evidence Strategy action is what RWE evidence-strategy director does next: implement the option, assign an owner, and log the missing fact.