Past Workshops
| 2009 |
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 Report (members only) Topic publication in RAPS journal Scope pending Workshop Synopsis pending |
| Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009 |
March 2009 Workshop Report.pdf (members only) March 2009 Workshop Report.pdf Proceedings publication in Clinical Pharmacology and Therapeutics pending |
|
| 2008 | Clinical development in Asia, Africa and Latin America: Streamlining procedures for global clinical trial approval Singapore: December 2008 |
Workshop Report (members only) R&D Briefing pending |
| Predictable outcomes: Why do potential winners fail? 30 September to 1 October 2008 |
Workshop Report (members only) R&D Briefing pending |
|
| 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 (members only) R&D Briefing pending |
|
| Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008 |
Workshop Report (members only) R&D Briefing pending |
|
| 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 | |
| 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 | |
| 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) | ||
| 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 |
|
| Beyond benchmarking: What are the key performance metrics that agencies and companies should use to measure performance? Washington DC, US: 4-5 October 2004 | ||
| 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 | ||
| 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 |
|
| 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. |