ATMP Postmarket Safety Strategy in – Playbook 9 ATMP Postmarket Safety Strategy in – Playbook 9 The implementation of robust post-market safety strategies for Advanced Therapy Medicinal Products (ATMPs) is critical to ensure ongoing patient safety and compliance with regulatory requirements. This tutorial provides a step-by-step guide to developing a comprehensive postmarket safety strategy, focusing on pharmacovigilance, Risk Management Plans (RMPs), Post-Authorization Safety Studies (PASS), and the use of registries. Step 1: Understanding Regulatory Requirements for ATMPs Before developing a postmarket safety strategy, it’s essential to understand the regulatory landscape governing ATMPs in the US. The FDA has established a…