The importance and impact of the EU RMP and US REMS to risk-benefit assessments

Regulatory Rapporteur

Volumn 8, Issue 2, 2011, Pages 20-23

  Dowlat, Hoss A ^a  

^a NONE

Author keywords

Package leaflet (PL); Patient information leaflet (PIL); Pharmacovigilance; Risk evaluation and mitigation strategy (REMS); Risk management plan (RMP); Risk minimisation action plan (RiskMAP); Summary of product characteristics (SmPC)

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; BOTULINUM TOXIN A; BUPRENORPHINE PLUS NALOXONE; ISOTRETINOIN; LAMOTRIGINE; LENALIDOMIDE; NEW DRUG; NOVEL ERYTHROPOIESIS STIMULATING PROTEIN; ROFECOXIB; TOCILIZUMAB;

ARTICLE; DRUG PACKAGING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; HEALTH CARE PLANNING; HEART INFARCTION; HUMAN; INTERNET; INTERPERSONAL COMMUNICATION; PATIENT; PHYSICIAN; PRESCRIPTION; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; RISK REDUCTION; STROKE;

EID: 79951506132     PISSN: 17428955     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (3)

1. Council for international organisations of medical sciences (WHO), CIOMS, Working Group IX on: "Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management".
2. Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications, September 2009.
3. Volume 9A of the Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Human Use - Final, September 2008. Part I - Guidelines for Marketing Authorisation Holders, (I) General Principles; (ii) Requirements for Pharmacovigilance Systems, Monitoring of Compliance and Pharmacovigilance Inspections; (iii) Requirements for Risk Management Systems, Annex C: Template for EU risk management plan (EU RMP), EMEA/192632/200.