Risk Management Plans in the European Union: Nonclinical Aspects

This article provides information to aid in the decision making of appropriate nonclinical content in the RMP and highlights the most common nonclinical endpoints discussed in published RMP summaries both as Identified or Potential Risks and as Planned Studies to further evaluate the risk.

Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Baldrick, P., Reeve, L. Tags: Global Perspectives Source Type: research