Past Workshops and Publications 2009-2008

Benefit-Risk

2011-2010 | 2009-2008 | 2007-2005 | 2004-2002

YEAR DESCRIPTION DOWNLOADS AND PUBLICATIONS
2009 Acceptability of data generated from foreign clinical trials and ethnic factors in drug development; Geneva, Switzerland: 23 - 24 November 2009

Workshop Programme PDF

Workshop Report        McAuslane N, Liberti L, Walker S, Connelly P. Emerging Markets:  Acceptability of data generated from foreign clinical trials and ethnic factors in drug development. CMR International Institute for Regulatory Science, November 2009.

  Review and reimbursement: A special case for better cooperation; Surrey, UK: 29-30 September 2009

Workshop Programme PDF

Workshop Report        Pichler F, Liberti L, Walker S, Connelly P. Review and reimbursement: A special case for better co-operation.  CMR International Institute for Regulatory Science, September 2009.  

Related Publication      Liberti, Lawrence E.; Pichler, Franz; Walker, Stuart R. 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.

  Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach  Washington, DC, US: 17-19 June 2009

Workshop Programme PDF

Workshop Report PDF

Related Publication     Liberti L, McAuslane N, Walker S.  Progress on the development of a benefit/risk framework for the evaluation of medicines. Regulatory Focus Copyright 2010 by the Regulatory Affairs Professional Society (RAPS). Reprinted from the March 2010 issue of Regulatory Focus with the permission of RAPS.

  Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009

Workshop Programme PDF

Workshop Report PDF 

Related Publication       Liberti L, Breckenridge A, Eichler H-G, Peterson, R, 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. 

Workshop Synopsis PDF

2008 Clinical development in Asia, Africa and Latin America: Streamlining procedures for global clinical trial approval Singapore: December 2008

Workshop Report    Walker S, McAuslane N, Cone M. Clinical development in Asia, Africa and Latin America: Streamlining the procedure for obtaining global clinical trial approvals. CMR International Institute for Regulatory Science, December, 2008.

  Predictable outcomes: Why do potential winners fail? 30 September to 1 October 2008

Workshop Report PDF

  Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US: 19-20 June 2008

Workshop Report PDF

Related Publication      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.

  Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008

Workshop Report PDF

  Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008

Workshop Report PDF

2011-2010 | 2009-2008 | 2007-2005 | 2004-2002