title: Roadmap to risk evaluation and mitigation strategies (REMS) success.
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.
authors.affiliation: Senior Vice President, Worldwide Safety and Regulatory Operations, Pfizer Medical, Pfizer Inc., New York, NY, USA.
authors.forename: John D
authors.initials: JD
authors.lastname: Balian
authors.affiliation: Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, NJ 08534, USA.
authors.forename: Janice C
authors.initials: JC
authors.lastname: Wherry
authors.affiliation: Director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Hopewell, NJ, USA.
authors.forename: Rachpal
authors.initials: R
authors.lastname: Malhotra
authors.affiliation: Executive Director, Operations and Aggregate Safety Reporting, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb, Hopewell, NJ, USA.
authors.forename: Valerie
authors.initials: V
authors.lastname: Perentesis
keywords: benefit/risk assessment; drug toxicity; risk management
references.citation: Clin Pharmacol Ther. 1995 Jun;57(6):662-9
references.pmid: 7781266
references.citation: Arch Dermatol. 2005 May;141(5):563-9
references.pmid: 15897377
references.citation: Eur J Health Econ. 2006 Jun;7(2):129-35
references.pmid: 16485122
references.citation: Nat Rev Drug Discov. 2009 Feb;8(2):93-6
references.pmid: 19180096
references.citation: J Pain. 2010 Jul;11(7):602-11
references.pmid: 20444651
references.citation: Am J Health Syst Pharm. 2009 Dec 15;66(24 Suppl 7):S13-20
references.pmid: 19966075
references.citation: Pharmacogenomics. 2009 Jun;10(6):961-9
references.pmid: 19530963
references.citation: Lancet. 2005 Feb 19-25;365(9460):711-22
references.pmid: 15721478