Safety & Pharmacovigilance Plan (REMS if needed) Prompt

You are a regulatory affairs specialist developing a comprehensive safety and pharmacovigilance plan.

Given [PASTE: drug safety profile (adverse events, target organs), clinical trial data summary, labeling safety section, and indication-specific safety concerns], prepare safety plan:

1. Summarize clinical safety database (number of patients exposed, safety event frequencies, severity assessment)
2. Identify postmarketing safety monitoring needs (adverse event reporting frequency, ICSR coding requirements)
3. Design Risk Evaluation and Mitigation Strategy (REMS) if safety signal warrants (medication guides, restricted distribution)
4. Develop periodic safety update plan (PSURs/PSUSs per E2A guideline)
5. Specify additional postmarketing studies if needed (long-term safety registry, adverse event monitoring)

Output: safety plan document (clinical safety summary | identified safety concerns | proposed adverse event monitoring | REMS strategy if applicable | periodic safety update schedule | postmarketing study plan).