Articles and Whitepapers

Risk & Program Management

REMS Among Rivals: Best Practices for Implementing Single Shared System REMS Programs
1/19/2015
Amy Tan, John West, Stephanie Cordato, and Jemma Contreras
Recently, the industry has seen the introduction and rise of single shared system REMS (SSSR) requirements, for which competing pharmaceutical companies are required to collaborate on a single shared REMS program for marketed products in the same or similar drug class. Through experiences working in the Program Management Office role across multiple SSSR programs, Campbell Alliance has learned about the intricacies and issues commonly faced by manufacturers in the unique situation of having to collaborate with their market competitors. This article identifies a number of selected best practices for companies seeking to develop an SSSR program to consider.
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Timelines and Tactics in Preparing for Single Shared REMS
1/19/2015
Jemma Contreras and John West
With the rise of single shared system Risk Evaluation and Mitigation Strategy (REMS) requirements, pharmaceutical companies are faced with the need to coordinate and reach consensus with their rivals in order to effectively meet the demands of FDA. This article focuses on the timelines—and the key challenges that can impact those timelines—in each of four main “phases” associated with the implementation of single shared system REMS programs. By understanding the core challenges and complexities involved in collaboratively implementing a single shared system REMS, companies may be better positioned to create and execute a successful and compliant REMS program.
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