Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies

Author:

Treacy Joanne,Morrato Elaine H.,Horne Robert,Wolf Michael S.,Bakhai Ameet,Wilson Marie-Claire,Lightowler Mark,Guerler Sibel,Jokinen JeremyORCID

Funder

Bristol-Myers Squibb

Publisher

Springer Science and Business Media LLC

Reference83 articles.

1. EMA. Guideline on good pharmacovigilance practices (GVP): Module V—risk management systems (Rev 2). EMA/838713/2011 Rev 2*. 2017.

2. EMA. Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I—educational materials. EMA/61341/2015. 2015.

3. Slatko GH. Risk evaluation and mitigation strategy (REMS): FDA perspective on what physicians need to know. Am Fam Physician. 2015;92(9):771–2.

4. Mouchantaf R, Auth D, Moride Y, Raine J, Han SY, Smith MY. Risk management for the 21st century: current status and future needs. Drug Saf. 2021;44(4):409–19. https://doi.org/10.1007/s40264-020-01033-z.

5. Russell A, Morrato EH, Lovett RM, Smith MY. Quality of reporting on the evaluation of risk minimization programs: a systematic review. Drug Saf. 2020;43(5):427–46. https://doi.org/10.1007/s40264-020-00905-8.

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