Risk Mitigation Excellence: Resources & Trends for REMS & RMP Programs

STUDY OVERVIEW

With regulators focused on the safety of new products, pharmaceutical organizations face ever increasing regulatory requirements for their new products. To meet these new standards, pharmaceutical organizations are relying on internal and external resources to support their risk-mitigation programs and meet compliance goals.

This new research study from Best Practices, LLC, examines the internal and external resources that leading organizations use to support Risk Evaluation & Mitigation Strategy (REMS) programs. In addition, the study reviews the challenges of implementing communication plans and trends in the European market for implementing Risk Minimization Plans (RMPs).

Best Practices, LLC conducted this research to help REMS leaders understand current trends in dealing with risk mitigation plans.

KEY TOPICS

• Leveraging Resources for REMS Efficiency & Excellence (Internal & External)
• REMS Communication Plans: Current Challenges
• RMP: Key Trends in Risk Management Plans for Succeeding in the European Market
• Appendix: Voices From The Field
  

• Percentage of REMS research that is conducted internally versus outsourced to external vendors
• Resources used by REMS function to utilize REMS Plans (Data) from other companies
• Resources used by REMS function to utilize internal research completed by brand teams and franchise units
• [Have you] collaborated with other companies with similar treatments in developing any facets of your REMS plan components
• Current challenges associated with Communication Plan research
• Most effective sources for identifying risks to be addressed by the Safety Specification element of a drug’s RMP
• Techniques or tools used to measure 'acceptable' vs. 'unacceptable' risk(s) of a particular product
• Vehicle(s) and techniques used to communicate risk of a particular product
• Resources and activities used to determine Communication-of-Risk levels for a given product
• Effectiveness rating of Communication-of-Risk plans once it has been implemented
• Use of Market Research to support Risk Minimization Plan
• Biggest challenges with RMPs

• 35% have Collaborated with Other Companies on REMS Development : Companies mainly collaborate with other organizations that support similar products or therapeutic areas. The most common REMS areas on which to collaborate are around either ETASUs (67% of collaborating companies) or with respect to FDA interactions to help ensure compliance or learn about specific therapeutic area standards – a phenomenon which also happens at 67% of companies.
• Companies Look to Benchmark Drug Class to Determine “Acceptable” Risk Levels: Although companies actively work to communicate and mitigate all the risks associated with product treatment, they also recognize the importance of focusing their efforts to do the most possible good. To do so, 60% of firms use a drug’s class as a useful benchmark, with another 47% employ risk matrices. Only 13% currently use third-party analysis.

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