Roadmap to risk evaluation and mitigation strategies (REMS) success-Reference-Cited by-同舟云学术

Roadmap to risk evaluation and mitigation strategies (REMS) success

Published:2010-10 Issue:1 Volume:1 Page:21-38
ISSN:2042-0986
Container-title:Therapeutic Advances in Drug Safety
language:en
Short-container-title:Therapeutic Advances in Drug Safety

Author:

Balian John D.¹,Wherry Janice C.²,Malhotra Rachpal³,Perentesis Valerie⁴

Affiliation:

1. Senior Vice President, Worldwide Safety and Regulatory Operations, Pfizer Medical, Pfizer Inc., New York, NY, USA

2. Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, NJ 08534, USA

3. Director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Hopewell, NJ, USA

4. Executive Director, Operations and Aggregate Safety Reporting, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Hopewell, NJ, USA

Abstract

Medical safety-related risk management is a rapidly evolving and increasingly important aspect of drug approval and market longevity. To effectively meet the challenges of this new era, we describe a risk management roadmap that proactively yet practically anticipates risk-management requirements, provides the foundation for enduring yet appropriately flexible risk-management practices, and leverages these techniques to efficiently and effectively utilize risk evaluation and mitigation strategies (REMS)/risk minimization programs as market access enablers. This fully integrated risk-management paradigm creates exciting opportunities for newer tools, techniques, and approaches to more successfully optimize product development, approval, and commercialization, with patients as the ultimate beneficiaries.

Publisher

SAGE Publications

Subject

Pharmacology (medical)

Link

http://journals.sagepub.com/doi/pdf/10.1177/2042098610381419

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