Some Thoughts on Pharmacovigilance and Postmarketing Surveillance

[...]it is less common now for sufficient numbers of patients to be studied before marketing to understand fully the pharmacology of these new NCEs. REMS can be quite varied, ranging from the distribution of medication guides (patient package inserts), to specific training for prescribing clinicians, to conducting new clinical studies that focus on the matter of concern.3 Our Guest Editor for this topic is our new Consulting Editor for Pharmacovigilance and Pharmacoepidemiology, Paul Beninger, MD. Paul is also vice president and senior medical advisor, Global Safety Science, Global Pharmacovigilance and Epidemiology at Sanofi as well as an assistant professor and director of the MD/MBA Program in the Department of Public Health and Community Medicine at Tufts University School of Medicine.