CIRS Agenda_2015.indd

Global Development Programme  

Publications and Presentations

Please find in the table below, all recent publications and presentations pertaining to the Global Development programme, this list includes R&D Briefings, publications, posters and white papers with content and research relevant to this programme.

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

Year Publication Type Focus
YearWorkshopPublication TypePublication TitleFocus
YearWorkshopPublication Type (all)Publication TitleFocus (all)
2015NABookLeong 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
2009NABookMussen 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
2016N/ABookAl-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
2015NAJournal 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
2015NAJournal ArticleLiberti 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
2014NAJournal ArticleAl-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
2014NAJournal ArticleLevitan 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.comGlobal Development, Regulatory, Benefit-Risk, UMBRA
2015NAJournal ArticleAlsager 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
2015NAJournal ArticleAl-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
2015NAJournal ArticleDonelan 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
2014NAJournal ArticleLeong 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
2013NAJournal ArticleLiu 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
2013NAJournal ArticleLeong 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
2013NAJournal ArticleLiberti 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
2012NAJournal ArticleWalker 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
2012NAJournal ArticleAl-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
2012NAJournal ArticleAl-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
2012NAJournal ArticleSalek 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
2011Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Journal ArticleWalker 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
2011NAJournal ArticleLiberti 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
2011NAJournal ArticleWalker 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
2011NAJournal ArticleAl-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
2010Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009Journal ArticleLiberti 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
2010Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals,Journal ArticleLiberti 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
2010NAJournal ArticleBrizmohun N. Standardising Benefit:Risk Assessment Heads DIA EuroMeeting News. Regulatory Affairs J. 2010, 21:221-224.Global Development, Regulatory, Benefit-Risk, UMBRA
2010Refining the benefit-risk framework for the assessment of medicines: Valuing and weighting benefit and risk parameters, Washington, DC, US: 17-18 June 2010Journal ArticleWalker 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
2009Expediting Patients' Access to Medicines: Solutions to Simultaneous Submissions and Approvals,Journal ArticleLiberti 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
2009Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach, Washington, DC, US: 17-19 June 2009Journal ArticleLiberti 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
2009Review and reimbursement: A special case for better cooperation, Surrey, UK: 29-30 September 2009Journal ArticleLiberti, 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
2008Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US:Journal ArticleWalker 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
2007NAJournal ArticleHirako 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
2013NAJournal ArticleLiberti 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
2013NAJournal ArticleMcAuslane 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
2009NAJournal ArticleMcAuslane 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
2009Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US:Journal ArticleWalker 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
2007NAJournal ArticleMussen 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
2007NAJournal ArticleMussen 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
2016N/AJournal ArticleHajed 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
2016N/AJournal ArticleLipska 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
2013NAPosterLipska 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
2014NAPosterWang 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
2015NAPosterBujar 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 2015Global Development, Regulatory, Facilitated Regulatory Pathways
2015NAPosterBujar 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
2015NAPosterLiberti 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
2013NAPosterBrown 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
2013NAPosterLiberti 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
2011NAPosterAl-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
2011NAPosterMeister 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
2010NAPosterPatel 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
2010NAPosterAllen 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
2014NAPosterSkaltsa 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
2012NAPosterAl-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
2012NAPosterLeong 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
2016N/ARD BriefingR&D Briefing 59 The impact of the evolving regulatory environment on the approval of new medicines across six major authorities 2006-2015Global Development, Regulatory, Emerging Markets
2001NARD BriefingR&D 31: Review Times - Is There Still Room For Improvement?Global Development, Regulatory
2002NARD BriefingR&D 37: Adoption of the ICH E5 Guideline in Asia Pacific Global Development, Regulatory, Emerging Markets
2002NARD BriefingR&D 36: The Impact of the ICH E5 Guideline on global drug development Global Development, Regulatory, Emerging Markets
2003NARD BriefingR&D 40: Pharmacogenetics and Pharmacogenomics in Drug DevelopmentGlobal Development, Regulatory
2003Regulating Personalised Medicine: The role of pharmacogenetics and pharmacogenomics, Surrey, UK: April 2003RD BriefingR&D 39: Regulating Personalised MedicineGlobal Development, Regulatory
2003Managing Risk: Identifying and Developing Effective Stakeholder Communication During Drug Development, Washington DC, US: December 2002RD BriefingR&D 38: Stakeholder CommunicationGlobal Development, Regulatory
2004NARD BriefingR&D 45: Kingdom of Saudi Arabia: Factors Affecting the Timelines for the Authorisation and Availability of Medicinal ProductsGlobal Development, Regulatory, Emerging Markets
2004Global Drug Development: Issues for the Pharmaceutical Industry and Regulatory Authorities, Tokyo, Japan: 26-27 May 2004RD BriefingR&D 44: Global Drug Development and Regulatory Review: Is There a New Paradigm?Global Development, Regulatory, Emerging Markets
2004NARD BriefingR&D 43: Current Strategies in Global Drug DevelopmentGlobal Development, Regulatory, Emerging Markets
2004NARD BriefingR&D 42: The Changing Regulatory Environment: Perception and RealityGlobal Development, Regulatory
2004Regulatory Performance: Critical success Factors in TodayRD BriefingR&D 41: Regulatory PerformanceGlobal Development, Regulatory
2005NARD BriefingR&D 49: Emerging Markets: Latin AmericaGlobal Development, Regulatory, Emerging Markets
2005NARD BriefingR&D 48: Emerging Markets: The Middle East and AfricaGlobal Development, Regulatory, Emerging Markets
2005NARD BriefingR&D 47: Emerging Markets: South East Asia and the Western PacificGlobal Development, Regulatory, Emerging Markets
2006NARD BriefingR&D 50: A Cross-regional Comparison of the Regulatory Environment in Emerging MarketsGlobal Development, Regulatory, Emerging Markets
2006NARD BriefingR&D 46: Building Quality into Regulatory ActivitiesGlobal Development, Regulatory
2012NARD BriefingR&D 51 Characterising the influencers of submission Lag Time for medicines in the Emerging MarketsGlobal Development, Regulatory, Emerging Markets
2013NARD BriefingR&D 52: New Drug Approvals in ICH Countries 2003-2012 - Focus on 2012Global Development, Regulatory
2014NARD BriefingR&D 55: The impact of the changing regulatory environment on the approval of new medicines across six major authorities 2004-2013Global Development, Regulatory
2014NARD BriefingR&D 54: New drug approvals in ICH countries 2004-2013 - Focus on 2013Global Development, Regulatory
2014NARD BriefingR&D 53: Availability of new medicines - Characterising the factors influencing drug roll out to six marketsGlobal Development, Regulatory
2015NARD BriefingR&D Briefing 58: The changing regulatory environment in Latin America. Focus on good review practicesGlobal Development, Emerging Markets
2015NARD BriefingR&D Briefing 57: New Drug Approvals in ICH countries 2005-2014Global Development, Regulatory
2015NARD BriefingR&D Briefing 56: Understanding the Dynamics of China's Medicine Regulatory environmentGlobal Development, Regulatory, Emerging Markets
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
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
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
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
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
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
2016N/AJournal ArticleBujar 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
2016N/ARD BriefingR&D Briefing 59 Supplement: NASs approved by six major authorities in 2015Global Development, Regulatory
2016N/AJournal ArticleLiberti 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
2016N/APosterBujar 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/APosterSalek 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
2016N/APosterWang 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
2016N/APosterLiberti 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
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
2017N/ARD BriefingR&D Briefing 62: New drug approvals in ICH countries 2007 – 2016Global Development, Regulatory