Journal Articles

Liberti L. Mapping regulatory, health technology assessment, and coverage decision-making processes: A key to multistakeholder understanding. DIA Global Forum Special Section on Emerging Markets. February 2013: 15-17.

 

McAuslane N. Streamlining review processes in the Asian Pacific region: The importance of good review practices. DIA Global Forum Special Section on Emerging Markets. December 2012: 16-18.

 

Finn K. Why health technology assessment is here to stay. MedNous. 2012;6:12-13.

 

Salek S, Mallia-Milanes A, McAuslane N, Walker S. Development and application of Scorecards to assess the quality of a regulatory submission and its review. Drug Info J. 2012;46:73. 

 

Al-Essa R, Salek S, Walker S. Regulatory review process in the Gulf Cooperation Council States: Similarities and differences. Drug Info J. 2012;46:65.

 

Al-Essa R, Salek S, Walker S. An appraisal of good regulatory review practices in the Gulf Cooperation Council States. Drug Info J. 2012;46:57.

 

Walker S, McAuslane N, Liberti L. Developing a common benefit-risk assessment methodology for medicines: A progress report.  This article was published in the December 2011 issue of Scrip Regulatory Affairs.

 

Al-Essa R, Salek S, Walker SRW. The development of a strategic plan for strengthening drug regulation in the Gulf region. Scrip Regulatory Affairs. 2011; September. Available at www.scripregulatoryaffairs.com; accessed September 2011.  This article was published in the September 2011 issue of Scrip Regulatory Affairs.

 

Walker S, McAuslane N, Liberti L. Refining the benefit-risk framework for assessing medicines: valuing and weighting the parameters: a report on progress by regulators and industry on the development of a common benefit-risk assessment framework. Reg Affairs J. 2011;March:14-17. Available at http://www.rajpharma.com. Accessed July 2011.

 

Liberti L, McAuslane N, Walker S. Standardising the benefit-risk assessment of new medicines: practical applications for the pharmaceutical healthcare professional. Pharm Med. 2011;25:139-146.

 

Walker S, Liberti L, McAuslane N. Refining the benefit-risk framework for the assessment of medicines: valuing and weighting benefit and risk parameters. Clin Pharmacol Ther. 2011 89:179-82.

  

Brizmohun N. Standardising Benefit:Risk Assessment Heads DIA EuroMeeting News. Regulatory Affairs J. 2010; 21:221-224.

 

Liberti L, McAuslane N, Walker SR. Expediting Patients' Access to Medicines by Improving the Predictability of Drug Development and the Regulatory Approval Process. Clin Pharmacol Ther. 2010;87:27-31. 

 

Liberti L, McAuslane N, Walker SRW. Progress on the development of a benefit/risk framework for evaluating medicines. Regulatory Focus. 2010: March. Copyright 2010 by the Regulatory Affairs Professional Society (RAPS). Reprinted from the March 2010 Issue of Regulatory Focus with the permission of RAPS. PDF

 

Liberti L, Pichler, F, Walker SR. Preparing for Regulatory Review and Reimbursement Decisions: A Case for Cooperation between Regulatory Authorities, Sponsors and Health Technology Assessment Agencies. Pharm Med. 2009;23:263-267.

 

McAuslane N, Cone M, Collins J, Walker S. Emerging Markets and Emerging Agencies: A comparative study of how key regulatory agencies in Asia, Latin America, the Middle East and Africa are developing regulatory processes and review models for new medicinal products. Drug Info J. 2009;43:349-359.

 

Walker S, McAuslane N, Liberti L, Salek S. Measuring benefit and balancing risk: strategies for the benefit-risk assessment of new medicines in a risk-averse environment. Clin Pharmacol Ther. 2009; 85:241-246.

 

Mussen F, Salek S, Walker S, Phillips L. A quantitative approach to benefit-risk assessment of medicines - part 2: the practical application of a new model. Pharmacoepidemiol Drug Saf. 2007;16 Suppl 1:S16-41.

 

Mussen F, Salek S, Walker S. A quantitative approach to benefit-risk assessment of medicines - part 1: the development of a new model using multi-criteria decision analysis. Pharmacoepidemiol Drug Saf. 2007;16 Suppl 1:S2-S15.

 

Hirako M, McAuslane N, Salek S, Anderson C, Walker S. A Comparison of the Drug Review Process at Five International Regulatory Agencies. Drug Info J.2007;41:291–308.