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Given the complexity of balancing regulatory requirements and commercial objectives, Best Practices, LLC undertook benchmarking research to examine how leading life sciences and medical device companies develop and execute successful REMS plans for newly-approved drugs in the U.S. market.
In particular, the study provides insights around the structure and responsibilities of REMS teams, use of internal and external resources to support REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.
·Pharmacovigilance & Medical Affairs Functions Lead REMS: According to the study, REMS programs are mainly led by Pharmacovigilance (at 42% of benchmark companies) and Medical Affairs (26%). Additional support functions such as regulatory affairs, and sub-functions such as clinical and commercial also support overall REMS activities at some organizations. Market Research serves very limited role in REMS at any participating companies.
·“Internal Database and Past Internal REMS Plans Serve as Most Used Internal Resource: Most companies use past internal REMS programs, for drugs in different therapeutic area (65%) or same therapeutic area (53%). Almost half of the companies also refer internal research repositories/database.