P214: Streamlining Global Post-Approval Safety Monitoring Programs: A Standardized Framework
Poster Presenter
Yoon Jeon (Jamey) Kim
Director, Cluster Pharmacovigilance Lead
Merck & Co., Inc., Rahway, NJ, USA Panama
Objectives
To present a centralized Global Post-marketing Safety Monitoring Program framework at Merck & Co., Inc., Rahway, NJ, USA, which standardizes health authority commitments for safety information collection, enhancing operational efficiency and compliance across varying global regulatory landscapes.
Method
Implemented in 2017, the PSMP framework has evolved within Merck's global pharmacovigilance system. It employs standardized procedures overseen by the PSMP Review Committee to define requirements, establish a unified review system, and comply with diverse local regulatory requirements.
Results
Implementation of the PSMP framework has allowed Merck to maintain consistent oversight of Health Authority-mandated observational activities, thereby enhancing pharmacovigilance. Country specific requirements range from simple stimulated reporting mechanisms to formal data collection systems. The PSMP framework ensures systematic quality management globally, adhering to Good PV Practices:
1) Processes: Centralized safety monitoring activities ensure consistency across global PV operations and establish clear workflows and decision tree, guiding appropriate procedural pathways (e.g., Post-authorization safety studies (PASS) vs. PSMP).
2) Documents and Records Management: A Global PSMP template upholds documentation integrity, ensuring compliance with local regulations. The centralized repository for protocols and reports allows easy access and retrieval.
3) Knowledge Management: The PSMP Review Committee and PSMP Operation Enhancement team leverage cross-functional and local country expertise to provide guidance and share best practices, fostering a culture of continuous learning. A dedicated internal document repository houses the Country Regulations and FAQs, minimizing redundant communications and efficiently sharing resources.
4) Training and Education: A central training platform ensures understanding of PSMP processes, while the PSMP toolkit enhances the onboarding experience for new hires through self-directed learning.
5) Communication: The communication template and PSMP questionnaire help reviewers to understand the background and local regulatory requirements, reducing redundant communication and enhancing efficiency in reviewing protocols and reports.
6) Issue Management: A mechanism for prompt issue identification and management enables risk mitigation and commitment assurance.
7) External Party Management: Unified and consistent procedures support quality assurance for third-party activities and effective vendor relationship management.
Conclusion
In conclusion, the Post-marketing Safety Monitoring Program (PSMP) framework has significantly enhanced Merck's efficiency in managing commitments for safety information collection. By establishing centralized oversight and standardized procedures, the PSMP process ensures compliance with diverse health authority requirements. This framework facilitates communication between Headquarter and local operations, empowering teams with the necessary tools and guidelines for maintaining high standards of safety monitoring. As the regulatory landscape continues to evolve, the PSMP framework serves as a model for efficiently integrating global best practices while addressing local needs, ultimately contributing to enhanced patient safety.
