Past Workshops
| 2010 |
Refining the Benefit-Risk Framework for the Assessment of Medicines: Valuing and weighting benefit and risk parameters; Washington, DC: 17-18 June, 2010 |
Workshop Programme PDF |
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Review and Reimbursement: Aligning the needs and requirements in clinical development; Washington, DC: 23 - 24 March 2010 |
Workshop Programme PDF | |
| 2009 |
Acceptability of data generated from foreign clinical trials and ethnic factors in drug development; Geneva, Switzerland: 23 - 24 November 2009 |
Workshop Programme PDF |
| Review and reimbursement: A special case for better cooperation; Surrey, UK: 29-30 September 2009 | ||
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Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach Washington, DC, US: 17-19 June 2009 |
Topic Publication in 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. Workshop Synopsis pending |
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| Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009 |
Proceedings publication: 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. ttp://www.ncbi.nlm.nih.gov/pubmed/20019699 |
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| 2008 | Clinical development in Asia, Africa and Latin America: Streamlining procedures for global clinical trial approval Singapore: December 2008 |
R&D Briefing pending |
| Predictable outcomes: Why do potential winners fail? 30 September to 1 October 2008 |
R&D Briefing pending |
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| 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 |
R&D Briefing pending |
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| Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008 |
R&D Briefing pending |
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| Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008 | ||
| 2007 | The Emerging Markets: Models of Best Practice for the Regulatory Review of New Medicines, Geneva, Switzerland: 5-6 December 2007 | Workshop Report PDF |
| New approaches to product approval: Balancing early release with improved safety monitoring, 14-15 June 2007, Washington DC, USA | ||
| Rethinking early clinical testing: The translation from laboratory to clinic, Cobham, Surrey, UK: 16-17 April 2007 | ||
| 2006 | Quality Decision-Making: Procedures and practices in drug development and the regulatory review, Cobham, Surrey, UK: 7-8 December 2006 | Workshop Report PDF |
| Global Drug Development: Asia's role and contribution, Tokyo, Japan: October 2006 | ||
| New Technologies and Biomarkers: The Way Ahead, Washington, D.C., USA: May 2006 | ||
| Emerging Markets: Assessing the regulatory environment and its impact on patients’ access to new medicines Geneva Switzerland: 2-3 March 2006 (Postponed from December 2005) | Workshop Report PDF | |
| 2005 | A new paradigm for clinical research: A discussion of the ways pharmaceutical R&D needs to change in order to remain viable, Washington D.C: 3-4 October 2005 | |
| Post-approval commitments and conditional authorisations, Cobham, Surrey, UK: 13-14 May 2005 | ||
| 2004 | Building Quality into Regulatory Submissions and the Review Process: Knowing and meeting customer expectations, Cobham, Surrey, UK: 2-3 December 2004 |
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| Beyond benchmarking: What are the key performance metrics that agencies and companies should use to measure performance? Washington DC, US: 4-5 October 2004 | Workshop Report PDF | |
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Benefit-Risk Assessment: The Development of a Model for Benefit-Risk Assessment of Medicines Based on Multi-Criteria Decision Analysis London, UK: 29-30 March 2004 |
Workshop Report PDF | |
| Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004 | ||
| 2003 | Regulatory Performance: Critical success Factors in Today’s Environment, Washington DC, US: September 2003 | |
| Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003 | Workshop Report PDF | |
| 2002 | Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002 | |
| Risk Management: The Role of Regulatory Strategies in the Development of New Medicines, Surrey, UK: April 2002 |
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| The reports prepared following Institute Workshops and Studies have restricted circulation and are normally available only to Member Companies and Regulatory Authorities to whom they are provided through individual contacts. All publications (restricted and open access) are also provided on a CD in a format that can be used on company/agency intranets. Recent restricted access reports are not currently being added to this Website which is in process of re-structuring. Company members and staff of regulatory agencies may request individual reports or the CD by contacting the institute@cmr.org, using an authentic company or agency E-mail address. |