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Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.
Medical Device; Pharmaceutical; Biotech; Chemical; Consumer Products; Diagnostic; Health Care
Baxter International; Genericon Pharma; Actelion; MannKind Corporation; Bristol-Myers Squibb; Genentech; Roche; Bayer Healthcare; Cephalon; AstraZeneca; Inc.; Johnson & Johnson; Pfizer; Covidien; Amylin; Abbott; Upsher-Smith; Merz Pharma; Teva Pharmaceutical Industries Ltd; Ipsen
Research participants included 22 executives and managers from 19 leading pharmaceutical, biotech, and medical device companies.
All study participants contributed data through a field survey and representatives from several leading benchmark organizations also provided additional insights through deep-dive interviews.
Sample Key Findings
Pharmacovigilance & Regulatory Affairs Functions Lead REMS: According to the study, REMS programs are mainly led by Pharmacovigilance (at 41% of benchmark companies) and Regulatory Affairs (36%). Additional core functions such as Medical Affairs, and sub-functions such as Epidemiology, also lead overall REMS activities at some organizations. Market Research does not serve as a lead function for REMS at any participating companies.
Medication Guides & Communication Plans Are Primary REMS Components: Some 89% of companies boast experience in developing and disseminating Medication Guides for REMS products, and almost 3/4s of organizations have also deployed Communication Plans. In contrast, the use of other, often more onerous, REMS plan components such as ETASU (“Elements to Assure Safe Use” of a product, undertaken so far at only 37% of companies) and Implementation Plans (32%) is less common.
Collaboration on RMP and REMS Is Becoming More Frequent: Collaboration between RMP teams in Europe and REMS teams in the U.S. enables companies to increase efficiency and share both process and therapeutic-area knowledge. Though 53% do not currently collaborate on this front, a trend toward growing interaction and alignment between these similar teams was observable in this study.