| 2001 | NA | RD Briefing | R&D 31: Review Times - Is There Still Room For Improvement? | Global Development, Regulatory |
| 2002 | NA | RD Briefing | R&D 37: Adoption of the ICH E5 Guideline in Asia Pacific | Global Development, Regulatory, Emerging Markets |
| 2002 | NA | RD Briefing | R&D 36: The Impact of the ICH E5 Guideline on global drug development | Global Development, Regulatory, Emerging Markets |
| 2002 | Risk Management: The Role of Regulatory Strategies in the Development of New Medicines, Surrey, UK: April 2002 | Workshop Report | Report: Risk Management: The Role of Regulatory Strategies in the Development of New Medicines, Surrey, UK: April 2002 | Global Development, Regulatory |
| 2002 | Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002 | Workshop Report | Report: Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002 | Global Development, Regulatory |
| 2003 | NA | RD Briefing | R&D 40: Pharmacogenetics and Pharmacogenomics in Drug Development | Global Development, Regulatory |
| 2003 | Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003 | RD Briefing | R&D 39: Regulating Personalised Medicine | Global Development, Regulatory |
| 2003 | Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002 | RD Briefing | R&D 38: Stakeholder Communication | Global Development, Regulatory |
| 2003 | Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003 | Workshop Report | Report: Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003 | Global Development, Regulatory |
| 2003 | Regulatory Performance: Critical success Factors in Today's Environment, Washington DC, US: September 2003 | Workshop Report | Report: Regulatory Performance: Critical success Factors in Today's Environment, Washington DC, US: September 2003 | Global Development, Regulatory |
| 2004 | NA | RD Briefing | R&D 45: Kingdom of Saudi Arabia: Factors Affecting the Timelines for the Authorisation and Availability of Medicinal Products | Global Development, Regulatory, Emerging Markets |
| 2004 | Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004 | RD Briefing | R&D 44: Global Drug Development and Regulatory Review: Is There a New Paradigm? | Global Development, Regulatory, Emerging Markets |
| 2004 | NA | RD Briefing | R&D 43: Current Strategies in Global Drug Development | Global Development, Regulatory, Emerging Markets |
| 2004 | NA | RD Briefing | R&D 42: The Changing Regulatory Environment: Perception and Reality | Global Development, Regulatory |
| 2004 | Regulatory Performance: Critical success Factors in Today | RD Briefing | R&D 41: Regulatory Performance | Global Development, Regulatory |
| 2004 | Building Quality into Regulatory Submissions and the Review Process: Knowing and meeting customer expectations, Cobham, Surrey, UK: | Workshop Report | Report: Building Quality into Regulatory Submissions and the Review Process: Knowing and meeting customer expectations, Cobham, Surrey, UK: 2-3 December 2004 | Global Development, Regulatory |
| 2004 | 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 | Report: 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 | Global Development, Regulatory, UMBRA, Benefit-Risk, Benefit-Risk |
| 2004 | Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004 | Workshop Report | Report: Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004 | Global Development, Emerging Markets |
| 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 | Workshop Report | Report: 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 Development, Regulatory |
| 2005 | NA | RD Briefing | R&D 49: Emerging Markets: Latin America | Global Development, Regulatory, Emerging Markets |
| 2005 | NA | RD Briefing | R&D 48: Emerging Markets: The Middle East and Africa | Global Development, Regulatory, Emerging Markets |
| 2005 | NA | RD Briefing | R&D 47: Emerging Markets: South East Asia and the Western Pacific | Global Development, Regulatory, Emerging Markets |
| 2005 | Post-approval commitments and conditional authorisations, Cobham, Surrey, UK: 13-14 May 2005 | Workshop Report | Report: Post-approval commitments and conditional authorisations, Cobham, Surrey, UK: 13-14 May 2005 | Global Development, Regulatory |
| 2005 | Benefit-risk assessment model for medicines: Developing a structured approach to decision making, Washington DC, USA: 13-14 June 2005 | Workshop Report | Report: Benefit-risk assessment model for medicines: Developing a structured approach to decision making, Washington DC, USA: 13-14 June 2005 | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 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: | Workshop Report | Report: 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 | Global Development, Regulatory |
| 2006 | NA | RD Briefing | R&D 50: A Cross-regional Comparison of the Regulatory Environment in Emerging Markets | Global Development, Regulatory, Emerging Markets |
| 2006 | NA | RD Briefing | R&D 46: Building Quality into Regulatory Activities | Global Development, Regulatory |
| 2006 | Quality Decision-Making: Procedures and practices in drug development and the regulatory review, Cobham, Surrey, UK: | Workshop Report | Report: Quality Decision-Making: Procedures and practices in drug development and the regulatory review, Cobham, Surrey, UK: 7-8 December 2006 | Global Development, Regulatory |
| 2006 | Emerging Markets: Assessing the regulatory environment and its impact on patients | Workshop Report | Report: Emerging Markets: Assessing the regulatory environment and its impact on patients' access to new medicines; Geneva, April 2006 | Global Development, Emerging Markets |
| 2006 | New Technologies and Biomarkers: The Way Ahead, Washington, D.C., USA: May 2006 | Workshop Report | Report: New Technologies and Biomarkers: The Way Ahead, Washington, D.C., USA: May 2006 | Global Development, Regulatory |
| 2006 | Global Drug Development: Asia's role and contribution, Tokyo, Japan: October 2006 | Workshop Report | Report: Global Drug Development: Asia's role and contribution, Tokyo, Japan: October 2006 | Global Development, Emerging Markets |
| 2007 | NA | Journal Article | 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. | Global Development, Regulatory |
| 2007 | NA | Journal Article | 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. | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2007 | NA | Journal Article | 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. | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2007 | The Emerging Markets: Models of Best Practice for the Regulatory Review of New MedicinesGeneva, Switzerland: 5-6 December 2007 | Workshop Report | Report: The Emerging Markets: Models of Best Practice for the Regulatory Review of New MedicinesGeneva, Switzerland: 5-6 December 2007 | Global Development, Emerging Markets |
| 2007 | New approaches to product approval: Balancing early release with improved safety monitoring, 14-15 June 2007, Washington DC, USA | Workshop Report | Report: New approaches to product approval: Balancing early release with improved safety monitoring, 14-15 June 2007, Washington DC, USA | Global Development, Regulatory |
| 2007 | Rethinking early clinical testing: The translation from laboratory to clinic, Cobham, Surrey, UK: 16-17 April 2007 | Workshop Report | Report: Rethinking early clinical testing: The translation from laboratory to clinic, Cobham, Surrey, UK: 16-17 April 2007 | Global Development, |
| 2008 | Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US: | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2008 | Predictable outcomes: Why do potential winners fail? | Workshop Report | Report: Predictable outcomes: Why do potential winners fail? Washington, DC: 30 Sept-1 Oct 2008 | Global Development, Regulatory |
| 2008 | Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008 | Workshop Report | Report: Knowledge Sharing and Cooperation: Are these the key to a more certain future for pharmaceutical innovation? Surrey, UK: 29-30 April 2008 | Global Development, Regulatory |
| 2008 | Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US: | Workshop Report | Report: 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 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2008 | Clinical development in Asia, Africa and Latin America: Streamlining procedures for global clinical trial approval Singapore: December 2008 | Workshop Report | Report: 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 |
| 2008 | Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008 | Workshop Report | Report: Regulation and Reimbursement: Two sides of the same coin Cobham, Surrey:16-17 January 2008 | Global Development, Regulatory, HTA/Market Access |
| 2009 | NA | Book | Mussen F, Salek S and Walker SR, eds. Benefit-Risk Appraisal of Medicines: A Systematic Approach to Decision Making. John Wiley: Surrey, UK. 2009. | Global Development, Regulatory, UMBRA, Benefit-Risk, Decision Making |
| 2009 | Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, | Journal Article | 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. | Global Development, Regulatory |
| 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 | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2009 | Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009 | Journal Article | 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. | Global Development, Regulatory, HTA/Market Access |
| 2009 | NA | Journal Article | 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. | Global Development, Regulatory, Emerging Markets |
| 2009 | Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US: | Journal Article | 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. | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2009 | Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, | Workshop Programme | Programme: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK:30-31 March 2009 | Global Development, Regulatory |
| 2009 | Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009 | Workshop Programme | Programme: Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009 | Global Development, Regulatory, HTA/Market Access |
| 2009 | Acceptability of data generated from foreign clinical trials and ethnic factors in drug development, | Workshop Programme | Programme: Acceptability of data generated from foreign clinical trials and ethnic factors in drug developmentGeneva, Switzerland: 23 - 24 November 2009 | Global Development, Emerging Markets |
| 2009 | Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, | Workshop Report | Report: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009 | Global Development, Regulatory |
| 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 | Report: Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2009 | Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009 | Workshop Report | Report 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 |
| 2009 | Acceptability of data generated from foreign clinical trials and ethnic factors in drug development, | Workshop Report | Emerging 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 |
| 2009 | Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, | Workshop Synopsis | Synopsis: Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, Surrey, UK: 30-31 March 2009 | Global Development, Regulatory |
| 2010 | Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009 | Journal Article | 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 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2010 | Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals, | Journal Article | 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. | Global Development, Regulatory |
| 2010 | NA | Journal Article | Brizmohun N. Standardising Benefit:Risk Assessment Heads DIA EuroMeeting News. Regulatory Affairs J. 2010, 21:221-224. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2010 | Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2010 | NA | Poster | Patel P, McAuslane JAN, Liberti L. Agency activity and company strategy - How are these influencing time to market for new medicines in the emerging markets? Washington, DC: Annual Meeting of the Drug Information Association, June 2010. | Global Development, Regulatory, Emerging Markets |
| 2010 | NA | Poster | Allen N, Pichler F, Salek MS. Assessing performance and decision making by comparing key milestones from approval to reimbursement in eleven leading countries. The 46th DIA Annual Meeting. Washington DC, USA, 2010. | Global Development, Regulatory, HTA/Market Access, Decision Making |
| 2010 | Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US: | Workshop Programme | Programme: Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US: 23 - 24 March 2010 | Global Development, Regulatory, HTA/Market Access |
| 2010 | Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Workshop Programme | Programme: Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2010 | New development paradigms: | Workshop Programme | Programme: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010 | Global Development, Regulatory |
| 2010 | Review and Reimbursement: Aligning the needs and requirements in clinical development, Washington, DC, US: | Workshop Report | Report: 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 |
| 2010 | Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Workshop Report | Report: Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2010 | New development paradigms: | Workshop Report | Report: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010 | Global Development, Regulatory |
| 2010 | New development paradigms: | Workshop Synopsis | Synopsis: New development paradigms: Building regulatory confidence for the early release of medicines, Surrey, UK: 11-12 October 2010 | Global Development, Regulatory |
| 2011 | Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010 | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2011 | NA | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2011 | NA | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2011 | NA | Journal Article | 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. | Global Development, Regulatory, Emerging Markets |
| 2011 | NA | Poster | Al-Rubaie M, Salek S, Walker S. Comparisons of the Gulf States' and pharmaceutical companies' perspectives on the effectiveness of the GCC centralised procedure. Poster presentation, Chicago, Illinois: Annual Drug Information Association Meeting, June, 2011. | Global Development, Regulatory, Emerging Markets |
| 2011 | NA | Poster | Meister G, Yuvasheva E. The impact of FDA priority, accelerated, and fast-track reviews on approval times and postapproval regulatory activity. Poster presentation, Chicago, Illinois: Annual Drug Information Association Meeting, June 2011. | Global Development, Regulatory |
| 2011 | 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 2011 | Workshop Programme | Programme: 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 2011 | Global Development, Regulatory, Emerging Markets |
| 2011 | 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 2011 | Workshop Programme | Programme: 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 2011 | Global Development, Regulatory, Emerging Markets, Decision Making |
| 2011 | Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Workshop Programme | Programme: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Global Development, Regulatory, HTA/Market Access |
| 2011 | Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Workshop Programme | Programme: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 2011 | 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 2011 | Workshop Report | Report: 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 2011 | Global Development, Regulatory, Emerging Markets |
| 2011 | 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 2011 | Workshop Report | Report: 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 2011 | Global Development, Regulatory, Emerging Markets, Decision Making |
| 2011 | Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Workshop Report | Report: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Global Development, Regulatory, HTA/Market Access |
| 2011 | Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Workshop Report | Report: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 2011 | 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 2011 | Workshop Synopsis | Synopsis: 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 2011 | Global Development, Regulatory, Emerging Markets |
| 2011 | 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 2011 | Workshop Synopsis | Synopsis: 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 2011 | Global Development, Regulatory, Emerging Markets, Decision Making |
| 2011 | Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Workshop Synopsis | Synopsis: Evidentiary requirements in clinical development: Synchronising phase III requirements to meet multiple needsGeneva, Switzerland: 31 March-1 April 2011 | Global Development, Regulatory, HTA/Market Access |
| 2011 | Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Workshop Synopsis | Synopsis: Visualising Benefit-Risk: The key to developing a framework that informs stakeholder perspective and clarity of decision making, Washington, DC, US: 16-17 June 2011 | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 2012 | NA | Journal Article | 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. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2012 | NA | Journal Article | 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. | Global Development, Regulatory, Emerging Markets |
| 2012 | NA | Journal Article | 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. | Global Development, Regulatory, Emerging Markets |
| 2012 | NA | Journal Article | 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. | Global Development, Regulatory |
| 2012 | NA | Poster | Al-Rubaie, M, Salek S, Walker S. Evaluation of the GCC centralised regulatory review process. Poster presentation, Philadelphia, PA, USA: Annual Meeting of the Drug Information Association, June 2012. | Global Development, Emerging Markets, Regulatory |
| 2012 | NA | Poster | Leong J, McAuslane N, Walker S, Salek S. Development and application of a universal benefit-risk assessment framework for medicines. Poster presentation, Philadelphia, PA, USA: Annual Meeting of the Drug Information Association, June 2012. | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2012 | NA | RD Briefing | R&D 51 Characterising the influencers of submission Lag Time for medicines in the Emerging Markets | Global Development, Regulatory, Emerging Markets |
| 2012 | The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012 | Workshop Programme | Programme: The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2012 | Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012 | Workshop Programme | Programme: Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012 | Global Development, Regulatory |
| 2012 | 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 | Workshop Programme | Programme: 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 |
| 2012 | 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 2012 | Workshop Programme | Programme: 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 2012 | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2012 | 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 2012 | Workshop Programme | Programme: 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 2012 | Global Development HTA/Market Access, Decision Making |
| 2012 | The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012 | Workshop Report | Report: The patient's role in the benefit-risk assessment for the submission and review of new medicines, Hampshire, UK: 25-26 April 2012 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2012 | Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012 | Workshop Report | Report: Balancing the Quality Scorecards: Regulatory review and submitted dossier, Burnham, UK: 5-6 March 2012 | Global Development, Regulatory |
| 2012 | 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 | Workshop Report | Report: 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 |
| 2012 | 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 2012 | Workshop Report | Report: 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 2012 | Global Development, HTA/Market Access, Decision Making |
| 2012 | 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 2012 | Workshop Report | Report: 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 2012 | Global Development, Regulatory, UMBRA, Benefit-Risk |
| 2012 | 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 | Workshop Synopsis | Synopsis: 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 |
| 2013 | NA | Journal Article | Liu LL, McAuslane N, Tzou M-C, Chern H-D, Liberti L, Ward M, Kang J-J. Characterizing Good Review Practices: A Survey Report Among Agencies of APEC Member Economies. Ther Innovation Reg Sci. 2013,213:47. | Global Development, Regulatory, Emerging Markets |
| 2013 | NA | Journal Article | Leong J, McAuslane N, Walker S, Salek S Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives. Pharmacoepidemiol Drug Saf. 2013,22:1004-1012. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2013 | NA | Journal Article | Liberti L, McAuslane N, Patel P, Breckenridge A, Eichler HG, Peterson R. Regulatory review: how do agencies ensure the quality of decision making? Clin Pharmacol Ther. 2013,94:305-308. | Global Development, Regulatory, Decision Making |
| 2013 | NA | Journal Article | 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. | Global Development, Regulatory, HTA/Market Access |
| 2013 | NA | Journal Article | 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. | Global Development, Regulatory, Emerging Markets |
| 2013 | NA | Poster | Lipska I, Hövels A, McAuslane N. The association between European Medicines Agency approval and Health Technology Assessment recommendations. Center for Innovation in Regulatory Science poster presentation: ISPOR, Dublin, Ireland, 2-6 November 2013. | Global Development, Regulatory, HTA/Market Access |
| 2013 | NA | Poster | Brown AA. Communicating the benefits and risk of medicines to patients: The pharmacy student's point of view. Poster presentation, Boston Massachusetts: Annual Meeting of the Drug Information Association, June 2013. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2013 | NA | Poster | Liberti L, Patel P, McAuslane N. What are the attributes that companies believe would help agencies to make quality regulatory review decisions? Poster presentation, Boston Massachusetts: Annual Meeting of the Drug Information Association, June 2013. | Global Development, Regulatory, Decision Making |
| 2013 | NA | RD Briefing | R&D 52: New Drug Approvals in ICH Countries 2003-2012 - Focus on 2012 | Global Development, Regulatory |
| 2013 | 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: 24-2 | Workshop Programme | Programme: 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 2013 | Global Development, Emerging Markets, Decision Making |
| 2013 | The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 March 2013 | Workshop Programme | Programme: 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 |
| 2013 | Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June 2013 | Workshop Programme | Programme: Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2013 | Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October 2013 | Workshop Programme | Programme: Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October | Global Development, Regulatory, HTA/Market Access, Decision Making |
| 2013 | Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013 | Workshop Programme | Programme: Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2013 | 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: 24-2 | Workshop Report | Report: 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 2013 | Global Development, Emerging Markets, Decision Making |
| 2013 | The patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? Surrey, UK: 13-14 March 2013 | Workshop Report | Report: 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 |
| 2013 | Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June 2013 | Workshop Report | Report: Implementing an internationally acceptable framework for the benefit-risk assessment of medicines: How close are we to this objective? Washington, DC, US: 20-21 June | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2013 | Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October 2013 | Workshop Report | Report: Is there a commonality across the structured decision frameworks used by HTA and regulatory agencies? Surrey, UK: 1-2 October | Global Development, HTA/Market Access, Decision Making |
| 2013 | Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013 | Workshop Report | Report: Maximising the value of PBRERs: Company approaches to post-approval benefit-risk assessment, Philadelphia, USA:12 December 2013 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | NA | Journal Article | Al-Rubaie, Walker SR, Salek, SS. Evaluation of the Gulf Cooperation Council Centralized Procedure: The Way Forward. Ther Inn Reg Sci April 9, 2014. | Global Development, Regulatory, Emerging Markets |
| 2014 | NA | Journal Article | Levitan B, Phillips LD, Walker S. Structured Approaches to Benefit-Risk Assessment: A Case Study and the Patient Perspective. Ther Inn Reg Sci. Published online before print May 30, 2014, doi: 10.1177/2168479014536500.Therapeutic Innovation & Regulatory Sciencedij.sagepub.com | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | NA | Journal Article | Leong Wai Yeen J, Salek S, Walker S. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents. Frontiers Pharmacol. 2014,Dec 4,5:269. doi: 10.3389/fphar.2014.00269. eCollection. | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | NA | Poster | Wang T, Bujar M, McAuslane N. Availability of new medicines - Characterising the factors influencing drug roll out to six mature markets. Centre for Innovation in Regulatory Science Poster presentation: EuroDia, Vienna, Austria, 25-27 March 2014. | Global Development |
| 2014 | NA | Poster | Skaltsa K, Allen N, Blogg K, van Engen A. An archetype for classification and comparison of HTA activities in Latin America. Poster, ISPOR, Amsterdam, The Netherlands, November 2014. | HTA/Market AccessGlobal Development, Emerging Markets |
| 2014 | NA | RD Briefing | R&D 55: The impact of the changing regulatory environment on the approval of new medicines across six major authorities 2004-2013 | Global Development, Regulatory |
| 2014 | NA | RD Briefing | R&D 54: New drug approvals in ICH countries 2004-2013 - Focus on 2013 | Global Development, Regulatory |
| 2014 | NA | RD Briefing | R&D 53: Availability of new medicines - Characterising the factors influencing drug roll out to six markets | Global Development, Regulatory |
| 2014 | 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 2014 | Workshop Programme | Programme: 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 2014 | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 2014 | 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 2014 | Workshop Programme | Programme: 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 2014 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | Focus on Latin America: Building Quality Submission and Review Processes and Practices | Workshop Programme | Programme: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014 | Global Development, Regulatory, Emerging Markets |
| 2014 | 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 2014 | Workshop Programme | Programme: 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 2014 | Global Development, Regulatory, HTA/Market Access |
| 2014 | Medicines adaptive pathways: A practical strategy to improve patient access to medicines? Heathrow, UK: 1-2 October 2014 | Workshop Programme | Programme: Medicines adaptive pathways: A practical strategy to improve patient access to medicines? Heathrow, UK: 1-2 October 2014 | Global Development, Regulatory |
| 2014 | 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 2014 | Workshop Programme | Programme: 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 2014 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | How is the value proposition driving the development and reimbursement process in major markets? Vancouver, Canada: 2-3 December 2014 | Workshop Report | Report: How is the value proposition driving the development and reimbursement process in major markets? Vancouver, Canada: 2-3 December 2014 | Global Development, Regulatory, HTA/Market Access |
| 2014 | 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 2014 | Workshop Report | Report: 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 2014 | Global Development, Regulatory, Benefit-Risk, UMBRA |
| 2014 | Focus on Latin America: Building Quality Submission and Review Processes and Practices | Workshop Report | Report: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014 | Global Development, Regulatory, Emerging Markets |
| 2014 | Medicines adaptive pathways: A practical strategy to improve patient access to medicines, Heathrow, UK: 1-2 October 2014 | Workshop Report | Workshop report: Medicines adaptive pathways: A practical strategy to improve patient access to medicines | Global Development, Regulatory, HTA/Market Access |
| 2014 | Benefit-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 Report | Workshop report: Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risks | Global development, Regulatory, Benefit-Risk |
| 2014 | Focus on Latin America: Building Quality Submission and Review Processes and Practices | Workshop Synopsis | Synopsis: Focus on Latin America: Building Quality Submission and Review Processes and Practices - Overcoming challenges and meeting expectations, Lima, Peru: 23-24 January 2014 | Global Development, Regulatory, Emerging Markets |
| 2015 | NA | Book | Leong J, Salek S, Walker S. The development and application of a universal framework for decision making and effective communication. New Zealand: Adis, 2015. | Global Development, Regulatory, Benefit-Risk, UMBRA, Decision Making |
| 2015 | NA | Journal Article | Liberti L, Stolk P, McAuslane N, Somauroo A, Breckenridge AM, Leufkens H. Adaptive licensing and facilitated regulatory pathways: A survey of stakeholder perceptions. Clin Pharmacol Ther. 2015 [Epub ahead of print] PubMed PMID: 25877216. | Global Development, Regulatory, Facilitated Regulatory Pathways |
| 2015 | NA | Journal Article | Liberti L, Stolk P, McAuslane N, Schellens J, Breckenridge A, Leufkens H. Observations on three end point properties and their relationship to regulatory outcomes of European oncology marketing applications. The Oncologist. 2015 [Epub ahead of print] PubMed PMID: 25948678. | Global Development, Regulatory |
| 2015 | NA | Journal Article | Alsager S, Hashan H, Walker S. The Saudi Food and Drug Authority:Shaping the Regulatory Environment in the Gulf Region. Pharm Med. 2015, published online 24 March 2015. | Global Development, Regulatory, Emerging Markets |
| 2015 | NA | Journal Article | Al-Rubaie M, Salek S, Walker S. An evaluation of the efficiency of the Gulf Cooperation Council's Centralized Procedure by the Gulf Regulatory Authorities and Pharmaceutical Companies: Recommendations for an Improved Model. Ther Innov Reg Sci. 2015, 1-9. | Global Development, Regulatory, Emerging Markets |
| 2015 | NA | Journal Article | Donelan R, Walker S, Salek S. Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives. Pharmacoepidemiol Drug Safety. 2015,24:319-328. | Global Development, Regulatory, Decision Making |
| 2015 | NA | Poster | Bujar M, McAuslane N, Liberti L. Expediting the availability of new medicines: What role do priority pathways and special designations play in ICH countries? Poster, EURO DIA, Paris, France, April 2015 | Global Development, Regulatory, Facilitated Regulatory Pathways |
| 2015 | NA | Poster | Bujar M, Patel P, McAuslane N. Drug lag and approval time metrics - are they good markers to assess the global regulatory environment? Poster presented at DIA Annual Meeting, June 2015 | Global Development, Regulatory, Emerging Markets |
| 2015 | NA | Poster | Liberti L, Stolk P, McAuslane N, Somauroo A, Breckenridge A, Leufkens H. Adaptive licensing and facilitated regulatory pathways: A stakeholder perception survey. Presented at the annual Winter Meeting of the WHO Collaborating Centre for Pharmaceutical Policy and Regulation, Utrecht University, Utrecht, The Netherlands, 13 January 2015. | Global Development, Regulatory |
| 2015 | NA | RD Briefing | R&D Briefing 58: The changing regulatory environment in Latin America. Focus on good review practices | Global Development, Emerging Markets |
| 2015 | NA | RD Briefing | R&D Briefing 57: New Drug Approvals in ICH countries 2005-2014 | Global Development, Regulatory |
| 2015 | NA | RD Briefing | R&D Briefing 56: Understanding the Dynamics of China's Medicine Regulatory environment | Global Development, Regulatory, Emerging Markets |
| 2015 | What is the patient's role in informing the decision process for approval and reimbursement of new medicines? Heathrow, UK: 7-8 October 2015 | Workshop Programme | Programme: What is the patient's role in informing the decision process for approval and reimbursement of new medicines? Heathrow, UK: 7-8 October 2015 | Global Development, Regulatory, HTA/Market Access, Decision Making |
| 2015 | Exploring approaches to decision making. Washington, DC: 11-12 June 2015 | Workshop Programme | Programme: Exploring approaches to decision making. Washington, DC: 11-12 June 2015 | Global Development, Regulatory, Benefit-Risk, Decision Making |
| 2015 | 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 | Workshop Programme | Programme: 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, Benefit-Risk, UMBRA |
| 2015 | 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 | Workshop Report | Report: 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 |
| 2016 | N/A | Book | Al-Essa R, Al-Rubaie M, Walker S, Salek S. Pharmaceutical regulatory environment: Challenges and opportunities in the Gulf region. Adis; 2015. | Global Development, Regulatory, Emerging Markets |
| 2016 | N/A | Journal Article | Hajed Hashan, Ibrahim Aljuffali, Prisha Patel Stuart Walker.The Saudi Arabia Food and Drug Authority: An evaluation of the registration process and good review practices in Saudi Arabia in comparison with Australia, Canada and Singapore. Pharm Med. 2016;30:37-47. | Global development, Regulatory, Emerging Markets |
| 2016 | N/A | Journal Article | Lipska I, Hoekman J, McAuslane N, Leufkens HGM, HovelsAM. Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions? Clin Pharm Ther.2015; 98:489-491. | Global Development, Regulatory, HTA/Market Access |
| 2016 | N/A | Journal Article | Bujar M, McAuslane N, Salek S, Walker S. Quality of regulatory decision-making practices: issues facing companies and agencies. Ther Innov Reg Sci. 2016; February 3, 2016 | Global Development, Regulatory, Decision Making |
| 2016 | N/A | Journal Article | Liberti L, Breckenridge A, Hoekman J, Leufkens H, Lumpkin M, McAuslane N, Stolk P, Zhi K, Rägo L. Accelerating access to new medicines: Current status of facilitated regulatory pathways used by emerging regulatory authorities. J Public Health Policy. 2016 Mar 10. doi: 10.1057/jphp.2016.8. [Epub ahead of print] | Global Development, Regulatory, Emerging Markets |
| 2016 | N/A | Journal Article | Dorr, P, Wadworth A, Liberti L, McAuslane N, Wang T. An analysis of regulatory timings and outcomes for new drug applications submitted to Swissmedic compared with the US Food and Drug Administration and the European Medicines Agency. Ther Innov RegSci.2016;50:734-742. | Global Development, Regulatory |
| 2016 | N/A | Poster | Bujar M, McAuslane N, Salek S, Walker S. Factors influencing quality decision making in medicines development and regulatory review: Biases and best practices. Poster presented at DIA 2016, Philadelphia, US. | Global Development, Regulatory, Decision Making |
| 2016 | N/A | Poster | Salek S, Bujar M, Donelan R, Walker S. Innovation in regulatory science: Development and validation of an instrument for assessing the quality of decision making. Poster presented at DIA 2016, Philadelphia, US. | Global Development, Regulatory, Decision Making |
| 2016 | N/A | Poster | Wang T, Liberti L, McAuslane N. Acceptability of the active comparator used in global development in the local HTA submission across seven diverse jurisdictions. Poster, HTAi, Tokyo, 10-14 May 2016. | HTA/Market Access |
| 2016 | N/A | Poster | Liberti L, Breckenridge A, Hoekman J, Leufkens H, Lumpkin M, McAuslane N, Stolk P, Zhi K, Rägo L. Practical aspects of developing, implementing and using facilitated regulatory pathways in the emerging markets. Poster presented at DIA 2016, Philadelphia, US. | Global Development, Regulatory, Facilitated Regulatory Pathways, Emerging Markets |
| 2016 | N/A | RD Briefing | R&D Briefing 59 The impact of the evolving regulatory environment on the approval of new medicines across six major authorities 2006-2015 | Global Development, Regulatory, Emerging Markets |
| 2016 | N/A | RD Briefing | R&D Briefing 59 Supplement: NASs approved by six major authorities in 2015 | Global Development, Regulatory |
| 2016 | 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?
Kuala Lumpur, Malaysia: 3-4 February 2016
| Workshop Programme | Workshop 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, |
| 2016 | Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016 | Workshop Programme | Workshop programme: Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016 | Global Development, HTA/Market Access, Regulatory |
| 2016 | Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016 | Workshop Programme | Workshop programme: Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016 | Global Development, HTA/Market Access, Regulatory |
| 2016 | What 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 2016 | Workshop Report | February 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 |
| 2016 | Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016 | Workshop Synopsis | Workshop synopsis: Commonality in evidentiary requirements across regulatory and HTA stakeholders; Surrey, UK; 21 - 22 September 2016 | Global Development, HTA/Market Access, Regulatory |
| 2016 | Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016 | Workshop Synopsis | Workshop synopsis: Real-world data to real-world evidence for assessing efficacy and effectiveness; Tysons Corner, US; 23-24 June 2016 | Global Development, HTA/Market Access, Regulatory |
| 2017 | N/A | Journal Article | Liberti L, Bujar M, Breckenridge A, Hoekman J, McAuslaneN, Stolk P, Leufkens H. FDA facilitated regulatory pathways: visualizing their characteristics and authorisation timelines. Front Pharmacol. 2017 Apr 3;8:161. doi: 10.3389/fphar.2017.00161. | Global Development, Regulatory |
| 2017 | N/A | Journal Article | Haqaish, W.S.A., Obeidat, H., Patel, P, Walker S. The Jordan Food and Drug Administration: An evaluation of the registration process in comparison with Australia, Canada, Saudi Arabia and Singapore Pharm Med. 2017;31:21-30 | Global Development, Regulatory |
| 2017 | N/A | Journal Article | Liberti L, Breckenridge A, Hoekman J, McAuslane N, Stolk P, Leufkens H. Factors related to drug approvals: predictors of outcome? Drug Discov Today. 2017 Mar 10. pii: S1359-6446(17)30114-9. doi:10.1016/j.drudis.2017.03.003. | Global Development, Regulatory |
| 2017 | N/A | Journal Article | McAuslane N, Leong J, Liberti L, Walker S. The benefit-risk assessment of medicines. Experience of a consortium of medium-sized regulatory authorities. Ther Innov Reg Sci. 2017. DOI 10.1177/2168479017696260. | Benefit-Risk, Global Development, Regulatory |
| 2017 | N/A | Journal Article | Bujar M, Donelan R, McAuslane N, Walker S and Salek S. Assessing the quality of decision making in the development and regulatory review of medicines. Identifying biases and best practices. Ther Innov Reg Sci. 2017;50:250-256. doi.org/10.1177/2168479016662681 | Decision Making, Global Development, Regulatory |
| 2017 | N/A | Journal Article | Liberti L. The practical application of regulatory science: Impact on regulatory policy Liberti L. The practical application of regulatory science: Impact on regulatory policy and practice. Reg Rapporteur. 2018; 15:3-5-9.and practice. Reg Rapporteur. 2018; 15:3-5-9. | Global Development, Regulatory |
| 2017 | N/A | RD Briefing | R&D Briefing 62: New drug approvals in ICH countries 2007 – 2016 | Global Development, Regulatory |
| 2017 | N/A | RD Briefing | CIRS R&D Briefing 65: New drug approvals in six major authorities 2007 – 2016 Focus on the internationalisation of medicines | Global Development |
| 2017 | N/A | RD Briefing | CIRS R&D Briefing 65 New active substance list | Global Development |
| 2017 | N/A | RD Briefing | CIRS RD Briefing 63 HTA Process Mapping | Global Development, HTA/Market Access |
| 2017 | Facilitating the review of new medicines through risk-based evaluations:
How can a stratification process be utilised to achieve an effective use of resources? Sao Paulo, Brazil; 8-9 March 2017
| Workshop Programme | Workshop programme: Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be utilised to achieve an effective use of resources? Sao Paulo Brazil; 8-9 March 2017 | Global Development, Regulatory |
| 2017 | Facilitating the review of new medicines through risk-based evaluations:
How can a stratification process be utilised to achieve an effective use of resources? Sao Paulo, Brazil; 8-9 March 2017
| Workshop Report | Workshop report Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be utilised to achieve an effective use of resources? Sao Paulo Brazil; 8-9 March 2017 | Global Development, Regulatory |
| 2018 | N/A | Journal Article | Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of its registration process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018;9 DOI=10.3389/fphar.2018.0000. | Global Development, Regulatory |
| 2018 | N/A | Journal Article | Mashaki Ceyhan E, Gürsöz H, Alkan A, Coşkun H, Koyuncu O, Walker S. The Turkish Medicines and Medical Devices Agency: Comparison of its registration process with Australia, Canada, Saudi Arabia, and Singapore. Front Pharmacol. 2018;9 DOI=10.3389/fphar.2018. | Global Development |
| 2018 | N/A | Journal Article | Keyter A, Gouws J, Salek S, Walker S. The regulatory review process in South Africa: Challenges and opportunities for a new improved system. Ther Innov Reg Sci. 2018; doi/10.1177/2168479018776649 | Global Development |
| 2018 | N/A | RD Briefing | R&D Briefing 67 New drug approvals in six major authorities 2008 -2017: Focus on the availability of medicines and company size | Global Development, Regulatory |
| 2018 | N/A | RD Briefing | CIRS R&D Briefing 66: The CIRS‐BRAT Benefit‐Risk Assessment Tool: Global use experience 2012‐2017 | Global Development |
| 2019 | NA | RD Briefing | R&D Briefing 70 New drug approvals in six major authorities 2009-2018: Focus on Facilitated Regulatory Pathways and Orphan Status | Global Development, Emerging Markets |
| 2019 | NA | RD Briefing | R&D Briefing 71: Trends in the Regulatory Landscape for the Approval of New Medicines in Latin Americav | Global Development, Emerging Markets |
