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25DB




Products & Services Quality, Compliance and Regulatory Deployment

REMS Excellence: Models & Trends in Supporting REMS Program Success

ID: 5410


Features:

13 Info Graphics

15 Data Graphics

180+ Metrics


Pages/Slides: 38


Published: 2016


Delivery Format: Online PDF Document


 

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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.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from " REMS Excellence: Models & Trends in Supporting REMS Program Success"


STUDY OVERVIEW

Given the complexity of balancing regulatory imperatives and commercial objectives, Best Practices, LLC conducted a benchmarking study to explore how pharmaceutical companies develop and execute effective Risk Evaluation and Mitigation Strategy (REMS) plans for newly-approved drugs in the U.S. market.

The report provides leading insights and benchmarks around the structure and responsibilities of REMS teams, use of market research teams to support and benefit REMS programs, physician/ distributor compliance on ETASU, current challenges in REMS communication plans and innovative REMS approaches for new products.

KEY TOPICS

  • REMS Program: Structure & Responsibilities
  • Industry Experience In Developing & Deploying Successful REMS Plans
  • REMS Approaches For New Products
  • Leveraging Resources For REMS Efficiency & Excellence
  • REMS Communication Plans: Current Challenges

SAMPLE KEY METRICS
  • Function/Group leading REMS program at benchmarked companies
  • Effectiveness of communication plan and ETASU activities managed by REMS organization
  • Percentage of research associated with REMS plans conducted internally versus outsourced to external vendors
  • Resources used by REMS function to leverage external approved REMS plans (data) from other companies
  • Resources used by REMS function to leverage internal research completed by brand teams and franchise units

SAMPLE KEY FINDINGS
  • 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.

  • The FDA Website Is the Most Often Used External Resource: Some 74% of REMS teams refer to the FDA website for REMS plan direction. But a majority of companies also leverage internal research repositories and third-party vendor propriety databases to build out their REMS plans and execution steps.

METHODOLOGY

This study engaged 19 healthcare executives and leaders supporting REMS programs at 17 leading life sciences and medical device companies. More than 50% of research participants work at the level of director or senior director. Roughly one-fifth of participants serve either as president or CEO.


Industries Profiled:
Pharmaceutical; Health Care; Biotech; Biopharmaceutical; Clinical Research; Laboratories; Consulting; Manufacturing; Consumer Products; Diagnostic; Medical Device


Companies Profiled:
Abbvie; Sanofi; Novartis; Scientific Advantage; Arthur F. Morelli and Associates; UCB Pharma; Oxon Epidemiology; Baxter BioScience; Pfizer; Bayer; Reliance Life Sciences; Cadila Pharmaceuticals; Eisai; Gilead Sciences; Hospira; Lilly; MedicinesOracle


If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.