Past Workshops

Please find in the table below all recent documents compiled in relation to previous CIRS workshops; this information includes Workshop Reports, Workshop Synopses and Workshop Programmes.

For a full list of all CIRS publications and presentations, please visit the Publications Page

Year Publication Type Focus

YearWorkshopPublication TypePublication TitleFocus
2017N/AJournal articleLipska I, McAuslane N. Leufkens H. Hovels A. A decade of health technology assessment in Poland. Int J Technol Assess Health Care. 2017:1-8. doi:10.1017/S0266462317000563HTA/Market Access
2015What is the patient's role in informing the decision process for approval and reimbursement of new medicines? Heathrow, UK: 7-8 October 2015Workshop ProgrammeProgramme: What is the patient's role in informing the decision process for approval and reimbursement of new medicines? Heathrow, UK: 7-8 October 2015Global Development, Regulatory, HTA/Market Access, Decision Making
2015Exploring approaches to decision making. Washington, DC: 11-12 June 2015Workshop ProgrammeProgramme: Exploring approaches to decision making. Washington, DC: 11-12 June 2015Global Development, Regulatory, Benefit-Risk, Decision Making
2014Building quality into companies' benefit-risk decision making: How does the framework enable the decision-making process and what else needs to be considered, Philadelphia, PA: 5 December 2014Workshop ProgrammeProgramme: Building quality into companies' benefit-risk decision making: How does the framework enable the decision-making process and what else needs to be considered, Philadelphia, PA: 5 December 2014Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making
2011Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Workshop ProgrammeProgramme: Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Global Development, Regulatory, Emerging Markets
2014The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? Surrey, UK: 2-3 April 2014Workshop ProgrammeProgramme: The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? Surrey, UK: 2-3 April 2014Global Development, Regulatory, Benefit-Risk, UMBRA
2014Focus on Latin America: Building Quality Submission and Review Processes and PracticesWorkshop ProgrammeProgramme: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014Global Development, Regulatory, Emerging Markets
2013Regulatory Review - How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that can facilitate agencies to make quality decisions? Beijing, PR China: 24-2Workshop ProgrammeProgramme: Regulatory Review - How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that can facilitate agencies to make quality decisions? Beijing, PR China: 24-25 January 2013Global Development, Emerging Markets, Decision Making
2012The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012Workshop ProgrammeProgramme: The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012Global Development, Regulatory, Benefit-Risk, UMBRA
2015Utilisation of a common benefit-risk framework: Can it facilitate decision-making and improve communication within and across agencies? Taipei, Chinese Taipei: 2-3 February 2015Workshop ProgrammeProgramme: Utilisation of a common benefit-risk framework: Can it facilitate decision-making and improve communication within and across agencies? Taipei, Chinese Taipei: 2-3 February 2015Global Development, Regulatory, Benefit-Risk, UMBRA
2014How is the value proposition driving the development and reimbursement process in major markets: What are the strategies and practical steps companies can take in development? Vancouver, BC, Canada: 2-3 December 2014Workshop ProgrammeProgramme: How is the value proposition driving the development and reimbursement process in major markets: What are the strategies and practical steps companies can take in development? Vancouver, BC, Canada: 2-3 December 2014Global Development, Regulatory, HTA/Market Access
2014Medicines adaptive pathways: A practical strategy to improve patient access to medicines? Heathrow, UK: 1-2 October 2014Workshop ProgrammeProgramme: Medicines adaptive pathways: A practical strategy to improve patient access to medicines? Heathrow, UK: 1-2 October 2014Global Development, Regulatory
2014Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and harms of medicines, Washington, DC, USA: 12-13 June 2014Workshop ProgrammeProgramme: Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and harms of medicines, Washington, DC, USA: 12-13 June 2014Global Development, Regulatory, Benefit-Risk, UMBRA
2013The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 March 2013Workshop ProgrammeProgramme: The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 MarchGlobal Development, Regulatory, Benefit-Risk, UMBRA
2013Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June 2013Workshop ProgrammeProgramme: Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 JuneGlobal Development, Regulatory, Benefit-Risk, UMBRA
2013Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October 2013Workshop ProgrammeProgramme: Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 OctoberGlobal Development, Regulatory, HTA/Market Access, Decision Making
2013Building quality into HTA and coverage decision-making processes: What are the features of good practice in HTA? Heathrow, UK: 2-3 December 2013Workshop ProgrammeProgramme: Building quality into HTA and coverage decision-making processes: What are the features of good practice in HTA? Heathrow, UK: 2-3 December 2013HTA/Market Access, Decision Making
2013Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013Workshop ProgrammeProgramme: Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013Global Development, Regulatory, Benefit-Risk, UMBRA
2012Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012Workshop ProgrammeProgramme: Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012Global Development, Regulatory
2012Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012Workshop ProgrammeProgramme: Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012 Global Development, Regulatory, Benefit-Risk, UMBRA
2011Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Workshop ProgrammeProgramme: Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Global Development, Regulatory, Emerging Markets, Decision Making
2011Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Workshop ProgrammeProgramme: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Global Development, Regulatory, HTA/Market Access
2011Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Workshop ProgrammeProgramme: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making
2011Understanding HTA and coverageWorkshop ProgrammeProgramme: Understanding HTA and coverage decision-making processes: The key to facilitating transparent access to medicines, Surrey, UK: 28-29 September 2011HTA/Market Access
2010Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US:Workshop ProgrammeProgramme: Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US: 23 - 24 March 2010Global Development, Regulatory, HTA/Market Access
2010Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Workshop ProgrammeProgramme: Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Global Development, Regulatory, Benefit-Risk, UMBRA
2010New development paradigms:Workshop ProgrammeProgramme: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010Global Development, Regulatory
2009Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals,Workshop ProgrammeProgramme: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK:30-31 March 2009Global Development, Regulatory
2009Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009Workshop ProgrammeProgramme: Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009Global Development, Regulatory, HTA/Market Access
2009Acceptability of data generated from foreign clinical trials and ethnic factors in drug development,Workshop ProgrammeProgramme: Acceptability of data generated from foreign clinical trials and ethnic factors in drug developmentGeneva, Switzerland: 23 - 24 November 2009Global Development, Emerging Markets
2012Benefit-risk framework for the assessment of medicines: Valuing the options and determining the relative importance (weighting) of benefit and risk parameters, Philadelphia, USA: 13 December 2012Workshop ProgrammeProgramme: Benefit-risk framework for the assessment of medicines: Valuing the options and determining the relative importance (weighting") of benefit and risk parameters, Philadelphia, USA: 13 December 2012Global Development, Regulatory, UMBRA, Benefit-Risk
2012Companion diagnostics: Challenges for developing, regulating and coverage decision making at the beginning of the era of personalised medicine, Washington, DC, USA: 13-14 September 2012Workshop ProgrammeProgramme: Companion diagnostics: Challenges for developing, regulating and coverage decision making at the beginning of the era of personalised medicine, Washington, DC, USA: 13-14 September 2012Global Development HTA/Market Access, Decision Making
2016What are the key performance metrics that agencies and companies should use to measure the regulatory process and practices to facilitate the licensing of new medicines?
Kuala Lumpur, Malaysia: 3-4 February 2016
Workshop ProgrammeWorkshop programme: What are the key performance metrics that agencies and companies should use to measure the regulatory process and practices to facilitate the licensing of new medicines?Global development, Emerging Markets, Regulatory,
2015Utilisation of a common benefit-risk framework: Can it facilitate decision making and improve communication within and across agencies? Taipei, Chinese Taipei: 2-3 February 2015Workshop ReportReport: Utilisation of a common benefit-risk framework: Can it facilitate decision making and improve communication within and across agencies? Taipei, Chinese Taipei: 2-3 February 2015 Global Development, Regulatory, Emerging Markets, Benefit-Risk, Decision Making
2014How is the value proposition driving the development and reimbursement process in major markets? Vancouver, Canada: 2-3 December 2014Workshop ReportReport: How is the value proposition driving the development and reimbursement process in major markets? Vancouver, Canada: 2-3 December 2014Global Development, Regulatory, HTA/Market Access
2008Predictable outcomes: Why do potential winners fail?Workshop ReportReport: Predictable outcomes: Why do potential winners fail? Washington, DC: 30 Sept-1 Oct 2008Global Development, Regulatory
2011Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Workshop ReportReport: Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Global Development, Regulatory, Emerging Markets
2014The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? Surrey, UK: 2-3 April 2014Workshop ReportReport: The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? Surrey, UK: 2-3 April 2014Global Development, Regulatory, Benefit-Risk, UMBRA
2013Regulatory Review - How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that can facilitate agencies to make quality decisions? Beijing, PR China: 24-2Workshop ReportReport: Regulatory Review - How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that can facilitate agencies to make quality decisions? Beijing, PR China: 24-25 January 2013Global Development, Emerging Markets, Decision Making
2002Risk Management: The Role of Regulatory Strategies in the Development of New Medicines, Surrey, UK: April 2002Workshop ReportReport: Risk Management: The Role of Regulatory Strategies in the Development of New Medicines, Surrey, UK: April 2002Global Development, Regulatory
2006Quality Decision-Making: Procedures and practices in drug development and the regulatory review, Cobham, Surrey, UK:Workshop ReportReport: Quality Decision-Making: Procedures and practices in drug development and the regulatory review, Cobham, Surrey, UK: 7-8 December 2006Global Development, Regulatory
2012The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012Workshop ReportReport: The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012Global Development, Regulatory, Benefit-Risk, UMBRA
2002Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002Workshop ReportReport: Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002 Global Development, Regulatory
2014Focus on Latin America: Building Quality Submission and Review Processes and PracticesWorkshop ReportReport: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014Global Development, Regulatory, Emerging Markets
2013The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 March 2013Workshop ReportReport: The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 March Global Development, Regulatory, Benefit-Risk, UMBRA
2013Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June 2013Workshop ReportReport: Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 JuneGlobal Development, Regulatory, Benefit-Risk, UMBRA
2013Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October 2013Workshop ReportReport: Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 OctoberGlobal Development, HTA/Market Access, Decision Making
2013Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013Workshop ReportReport: Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013Global Development, Regulatory, Benefit-Risk, UMBRA
2012Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012Workshop ReportReport: Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012 Global Development, Regulatory
2012Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012Workshop ReportReport: Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012Global Development, Regulatory, Benefit-Risk, UMBRA
2012Companion diagnostics: Challenges for developing, regulating and coverage decision making at the beginning of the era of personalised medicine, Washington, DC, USA: 13-14 September 2012Workshop ReportReport: Companion diagnostics: Challenges for developing, regulating and coverage decision making at the beginning of the era of personalised medicine, Washington, DC, USA: 13-14 September 2012Global Development, HTA/Market Access, Decision Making
2011Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Workshop ReportReport: Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Global Development, Regulatory, Emerging Markets, Decision Making
2011Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Workshop ReportReport: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Global Development, Regulatory, HTA/Market Access
2011Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Workshop ReportReport: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making
2011Understanding HTA and coverageWorkshop ReportReport: Understanding HTA and coverage decision-making processes: The key to facilitating transparent access to medicines, Surrey, UK: 28-29 September 2011HTA/Market Access
2010Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US:Workshop ReportReport: Review and reimbursement: Aligning the needs and requirements in clinical development. Workshop Report, CMR International Institute for Regulatory Science. March 2010.Global Development, Regulatory, HTA/Market Access
2010Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Workshop ReportReport: Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Global Development, Regulatory, Benefit-Risk, UMBRA
2010New development paradigms:Workshop ReportReport: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010Global Development, Regulatory
2009Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals,Workshop ReportReport: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009Global Development, Regulatory
2009Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009Workshop ReportReport: Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009Global Development, Regulatory, Benefit-Risk, UMBRA
2009Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009Workshop ReportReport Liberti L, Walker S, Connelly P. Review and reimbursement: A special case for better co-operation. CMR International Institute for Regulatory Science, September 2009.Global Development, Regulatory, HTA/Market Access
2009Acceptability of data generated from foreign clinical trials and ethnic factors in drug development,Workshop ReportEmerging Markets: Acceptability of data generated from foreign clinical trials and ethnic factors in drug development. CMR International Institute for Regulatory Science, November 2009.Global Development, Emerging Markets
2008Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008Workshop ReportReport: Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008Global Development, Regulatory
2008Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US:Workshop ReportReport: 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 2008Global Development, Regulatory, Benefit-Risk, UMBRA
2006Emerging Markets: Assessing the regulatory environment and its impact on patientsWorkshop ReportReport: Emerging Markets: Assessing the regulatory environment and its impact on patients' access to new medicines; Geneva, April 2006Global Development, Emerging Markets
2006New Technologies and Biomarkers: The Way Ahead, Washington, D.C., USA: May 2006Workshop ReportReport: New Technologies and Biomarkers: The Way Ahead, Washington, D.C., USA: May 2006Global Development, Regulatory
2006Global Drug Development: Asia's role and contribution, Tokyo, Japan: October 2006Workshop ReportReport: Global Drug Development: Asia's role and contribution, Tokyo, Japan: October 2006Global Development, Emerging Markets
2005Post-approval commitments and conditional authorisations, Cobham, Surrey, UK: 13-14 May 2005Workshop ReportReport: Post-approval commitments and conditional authorisations, Cobham, Surrey, UK: 13-14 May 2005Global Development, Regulatory
2005Benefit-risk assessment model for medicines: Developing a structured approach to decision making, Washington DC, USA: 13-14 June 2005Workshop ReportReport: Benefit-risk assessment model for medicines: Developing a structured approach to decision making, Washington DC, USA: 13-14 June 2005Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making
2005A new paradigm for clinical research: A discussion of the ways pharmaceutical R&D needs to change in order to remain viable, Washington D.C:Workshop ReportReport: 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 2005Global Development, Regulatory
2004Building Quality into Regulatory Submissions and the Review Process: Knowing and meeting customer expectations, Cobham, Surrey, UK:Workshop ReportReport: Building Quality into Regulatory Submissions and the Review Process: Knowing and meeting customer expectations, Cobham, Surrey, UK: 2-3 December 2004Global Development, Regulatory
2003Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003Workshop ReportReport: Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003Global Development, Regulatory
2003Regulatory Performance: Critical success Factors in Today's Environment, Washington DC, US: September 2003Workshop ReportReport: Regulatory Performance: Critical success Factors in Today's Environment, Washington DC, US: September 2003Global Development, Regulatory
2004Benefit-Risk Assessment: The Development of a Model for Benefit-Risk Assessment of Medicines Based on Multi-Criteria Decision Analysis London, UK: 29-30 March 2004Workshop ReportReport: 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 2004Global Development, Regulatory, UMBRA, Benefit-Risk, Benefit-Risk
2004Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004Workshop ReportReport: Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004Global Development, Emerging Markets
2004Beyond benchmarking: What are the key performance metrics that agencies and companies should use to measure performance? Washington DC, US: 4-5 October 2004Workshop ReportReport: Beyond benchmarking: What are the key performance metrics that agencies and companies should use to measure performance? Washington DC, US: 4-5 October 2004Global Development, Regulatory
2007The Emerging Markets: Models of Best Practice for the Regulatory Review of New MedicinesGeneva, Switzerland: 5-6 December 2007Workshop ReportReport: The Emerging Markets: Models of Best Practice for the Regulatory Review of New MedicinesGeneva, Switzerland: 5-6 December 2007Global Development, Emerging Markets
2007New approaches to product approval: Balancing early release with improved safety monitoring, 14-15 June 2007, Washington DC, USAWorkshop ReportReport: New approaches to product approval: Balancing early release with improved safety monitoring, 14-15 June 2007, Washington DC, USAGlobal Development, Regulatory
2007Rethinking early clinical testing: The translation from laboratory to clinic, Cobham, Surrey, UK: 16-17 April 2007Workshop ReportReport: Rethinking early clinical testing: The translation from laboratory to clinic, Cobham, Surrey, UK: 16-17 April 2007Global Development,
2008Clinical development in Asia, Africa and Latin America: Streamlining procedures for global clinical trial approval Singapore: December 2008Workshop ReportReport: 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.Global Development, Emerging Markets
2008Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008Workshop ReportReport: Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008Global Development, Regulatory, HTA/Market Access
2012Benefit-risk framework for the assessment of medicines: Valuing the options and determining the relative importance (weighting) of benefit and risk parameters, Philadelphia, USA: 13 December 2012Workshop ReportReport: Benefit-risk framework for the assessment of medicines: Valuing the options and determining the relative importance (weighting") of benefit and risk parameters, Philadelphia, USA: 13 December 2012Global Development, Regulatory, UMBRA, Benefit-Risk
2014Medicines adaptive pathways: A practical strategy to improve patient access to medicines, Heathrow, UK: 1-2 October 2014Workshop ReportWorkshop report: Medicines adaptive pathways: A practical strategy to improve patient access to medicinesGlobal Development, Regulatory, HTA/Market Access
2014Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risks,
Washington, DC, US: 12-13 June 2014
Workshop ReportWorkshop report: Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risksGlobal development, Regulatory, Benefit-Risk
2011Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Workshop SynopsisSynopsis: Evolving the Regulatory Review Process What are the features which enable a transparent, timely, predictable and good quality review, Kuala Lumpur, Malaysia: 6-7 December 2011Global Development, Regulatory, Emerging Markets
2014Focus on Latin America: Building Quality Submission and Review Processes and PracticesWorkshop SynopsisSynopsis: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014Global Development, Regulatory, Emerging Markets
2013Building quality into HTA and coverage decision-making processes: What are the features of good practice in HTA? Heathrow, UK: 2-3 December 2013Workshop SynopsisSynopsis: Building quality into HTA and coverage decision-making processes: What are the features of good practice in HTA? Heathrow, UK: 2-3 December 2013HTA/Market Access, Decision Making
2012Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012Workshop SynopsisSynopsis: Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? Washington, DC, USA: 20-21 June 2012Global Development, Regulatory, Benefit-Risk, UMBRA
2011Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Workshop SynopsisSynopsis: Regional Alignment in Asia Pacific: What needs to be in the regulatory science "toolkit" to enable good regulatory decision making, Tokyo, Japan: 26-27 January 2011Global Development, Regulatory, Emerging Markets, Decision Making
2011Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Workshop SynopsisSynopsis: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011Global Development, Regulatory, HTA/Market Access
2011Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Workshop SynopsisSynopsis: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making
2011Understanding HTA and coverageWorkshop SynopsisSynopsis: Understanding HTA and coverage decision-making processes: The key to facilitating transparent access to medicines, Surrey, UK: 28-29 September 2011HTA/Market Access
2010New development paradigms:Workshop SynopsisSynopsis: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010Global Development, Regulatory
2009Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals,Workshop SynopsisSynopsis: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009Global Development, Regulatory
2016What are the key performance indicators that agencies and companies can use to measure regulatory processes and practices to facilitate the licensing of new medicines; Kuala Lumpur, Malaysia; 3-4 February 2016Workshop ReportFebruary 2016 Workshop Report: What are the key performance indicators that agencies and companies should use to measure regulatory processes and practices to facilitate the licensing of new medicines Global Development, Regulatory, Emerging Markets
2016Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016Workshop ProgrammeWorkshop programme: Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016Global Development, HTA/Market Access, Regulatory
2016Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016Workshop SynopsisWorkshop synopsis: Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016Global Development, HTA/Market Access, Regulatory
2016Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016Workshop ProgrammeWorkshop programme: Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016Global Development, HTA/Market Access, Regulatory
2016Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016Workshop SynopsisWorkshop synopsis: Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016Global Development, HTA/Market Access, Regulatory