Risk-Based Approach for ATMP Evaluation Regulatory Strategy in 2023 – Playbook 10 Risk-Based Approach for ATMP Evaluation Regulatory Strategy in 2023 – Playbook 10 The regulatory landscape for Advanced Therapy Medicinal Products (ATMPs) necessitates a robust and compliant evaluation strategy, particularly as the complexities of development and commercialization unfold. Employing a risk-based approach can significantly enhance an organization’s ability to meet regulatory expectations while effectively managing product development risks. This article outlines a step-by-step guide focusing on the regulatory strategy for ATMP evaluation using a risk-based framework in 2023, catering specifically to a US audience. Commit to diligent planning and…