Development and Application of Scorecards to Assess the Quality of a Regulatory Submission and Its Review

Author:

Salek Sam,Mallia-Milanes Andrea,McAuslane Neil,Walker Stuart

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Reference15 articles.

1. Cone M, Walker S. Building Quality Into Regulatory Dossiers and the Review Process: ‘Knowing and Meeting Customer Expectations’. Workshop report. Surrey, UK: CMR International Institute; 2005.

2. Cone M, McAuslane N. Building Quality Into Regulatory Activities: What Does It Mean? Epsom, UK: CMR International; 2006. R&D Briefing 46.

3. Hirako M, McAuslane N, Salek S, Anderson C, Walker S. A comparison of the drug review process at five international regulatory agencies. Drug Inf J. 2007;41: 291–308.

4. Anderson C. An Evaluation of Harmonisation in the Regulatory Environment and Its Impact on Patients’ Access to New Medicines [doctor of philosophy thesis]. Cardiff, Wales: University of Wales; 2004.

5. Hashan H. Evaluation of the Review Process for Marketing Pharmaceutical Products in the Gulf States and Its Impact on Patients’ Access to Medicines [doctor of philosophy thesis]. Cardiff, Wales: University of Wales; 2005.

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