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Post Approval Monitoring. Group 3: Rosa Harmon, Jonathan Miller, Amy Salem, & Kate Ziegerer. Over-arching Goal: Learners will be able to effectively conduct Post Approval Monitoring (PAM). Session Goal: understand what constitutes PAM and appreciate its value to a research program.
SUDS. Who, What, Where & Why?. Suds is a Laundrobar & Café, located in the Old Port Green L aundromat in a Combo Bar & Café Wi-fi & Free P arking M usic & Entertainment Local E spresso & Coffee , S nacks , S odas & B eer Why?
SUDS. Who, What, Where & Why?. Suds is a Laundrobar & Café located in the Old Port Green L aundromat in a Combo Bar & Café Espresso & Coffee , S nacks , S odas & Beer Maine Weather + Clothing = > 6 Months Stuck in a Laundromat Why not do it guilt-free and somewhere fun?.
Post Approval Monitoring Program. Presented by Carolyn Malinowski Manager, Quality Assurance and Training . Discussion Areas. What is Post Approval Monitoring Why should we do this Who will be involved Logistics Implementation Questions. Post-Approval Monitoring (PAM).
Post Approval Monitoring Program. by Louisa Gay Post Approval Monitoring Officer. What is Post Approval Monitoring Why should we do this Who will be involved Logistics Questions. Discussion Areas.
Post Approval Stability Studies. LEARNING OBJECTIVES. Awareness of ICH / EMA / other Stability Guidelines Understand minimum requirements for Routine Stability study of marketed products (for API, Drug Product and Medical Device)
Post-Approval Monitoring Program. What is Post-Approval Monitoring? Why should we do this? Who will be involved? Logistics History Questions?. Discussion Areas.
Northwestern University Post Approval Monitoring. Performance Standard: The goal of post-approval monitoring is to work with, and in support of, research staff members and to confirm accurate and consistent protocol performance in a collegial and unobtrusive manner.