Entity

Time filter

Source Type


Fronsdal K.,Norwegian Knowledge Center for Health Services | Pichler F.,Center for Innovation in Regulatory Science | Mardhani-Bayne L.,Institute of Health Economics | Henshall C.,University of York | And 3 more authors.
International Journal of Technology Assessment in Health Care | Year: 2012

There has been an increased focus on the relationship between health technology assessment (HTA) and regulatory assessments and how regulatory, HTA and coverage bodies, and industry can work better together to improve efficiency and alignment of processes. There is increasingly agreement across sectors that improved communication and coordination could contribute to facilitating timely patient access to effective, affordable treatments that offer value to the health system. Discussions on aspects of this relationship are being held in different forums and various forms of coordination and collaboration are being developed or piloted within several jurisdictions. It is therefore both timely and of value to stakeholders to describe and reflect on current initiatives intended to improve interactions between regulatory, HTA and coverage bodies, and industry. Drawing on 2011 meetings of the HTAi Policy Forum and the Center for Innovation in Regulatory Science (CIRS), this study aims to describe and compare initiatives, and point to success factors and challenges that are likely to inform future work and collaboration. © Copyright 2012 Cambridge University Press.


Woolley K.L.,University of Queensland | Woolley K.L.,University of The Sunshine Coast | Gertel A.,Beardsworth Consulting Group Inc | Gertel A.,Center for Innovation in Regulatory Science | And 3 more authors.
Annals of Pharmacotherapy | Year: 2013

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem-they are a research problem. To enhance trust in industrysponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices. © 1967-2013 Harvey Whitney Books Co. All rights reserved.


Leong J.,National University of Singapore | Walker S.,Center for Innovation in Regulatory Science | Salek S.,University of Hertfordshire | Salek S.,Institute for Medicines Development
Frontiers in Pharmacology | Year: 2015

Purpose: The importance of a framework for a systematic structured assessment of the benefits and risks has been established, but in addition, it is necessary that the benefit-risk decisions and the processes to derive those decisions are documented and communicated to various stakeholders for accountability. Hence there is now a need to find appropriate tools to enhance communication between regulators and other stakeholders, in a manner that would uphold transparency, consistency and standards. Methods: A retrospective, non-comparative study was conducted to determine the applicability and practicality of a summary template in documenting benefit-risk assessment and communicating benefit-risk balance and conclusions for reviewers to other stakeholders. The benefit-risk (BR) Summary Template and its User Manual was evaluated by 12 reviewers within a regulatory agency in Singapore, the Health Sciences Authority (HSA). Results: The BR Summary Template was found to be adequate in documenting benefits, risks, relevant summaries and conclusions, while the User Manual was useful in guiding the reviewer in completing the template. The BR Summary Template was also considered a useful tool for communicating benefit-risk decisions to a variety of stakeholders. Conclusions: The use of a template may be of value for the communicating benefit-risk assessment of medicines to stakeholders. © 2015 Leong, Walker and Salek.


Donelan R.,Quintiles | Walker S.,Center for Innovation in Regulatory Science | Salek S.,University of Hertfordshire
Pharmacoepidemiology and Drug Safety | Year: 2015

Currently, there is no qualified understanding of the influences, behaviours and other factors that impact the decision-making of individuals and organisations involved in the development of new medicines. The aim of this qualitative study was to investigate and identify the important issues that influence quality decision-making. Methods: Semi-structured interviews were carried out with 29 senior decision-makers from the pharmaceutical industry and regulatory authorities. The study participants were invited to discuss and review their perception of decision-making within their organisation, its role in drug development and the regulatory review and their awareness and use of decision-making techniques and the impact and monitoring of decisions. Results: The analyses (using NVivo 8 software) resulted in the identification of 32 major and 97 sub-themes that were consolidated into 19 overarching themes. These included items such as quality and validity of data, time considerations, organisational and cultural influences, analytical and logical approach, qualification and experience, subjective and personal considerations, political influences, precedents for similar previous decisions, understanding of the decision in question, impact analyses, audit trail, education and awareness, individual versus corporate decision-making and frameworks. Relationships between themes were identified. The 19 overarching decision-making themes were integrated into a framework for quality decision-making. Conclusion: This study has achieved its aim of exploring decision-making from the perspective of the individual and the organisation working in drug development and the regulatory review and has identified issues and considerations relating to making good quality decisions and allowed for the generation of a framework to aid quality decision-making. © 2015 John Wiley & Sons, Ltd.


Alsager S.,North Ring Road Al Nafal Unit | Hashan H.,North Ring Road Al Nafal Unit | Walker S.,Center for Innovation in Regulatory Science | Walker S.,University of Cardiff
Pharmaceutical Medicine | Year: 2015

Objective: This study sought to assess the current regulatory review process in Saudi Arabia, identify the key milestones, evaluate the measures used for Good Review Practices (GRevP) and to suggest opportunities for an enhanced regulatory review of medicines.Methods: A questionnaire completed by the Saudi Food and Drug Authority (SFDA) was divided into three parts: Organisation of the Agency, Key Milestones and Timelines and GRevP.Results: Currently the SFDA carries out a full assessment for the review of all major applications, although they currently lack the expertise to evaluate the preclinical portion of the product file. A Certificate of Pharmaceutical Product (CPP) is required at the time of registration and a pricing agreement internally must be developed before authorisation. Applications may have to wait 2–6 months before review, although priority products are taken out of the queuing system. The median review times for new active substances from submission to approval were 340 working days (2011) and 372 working days (2013); however, the target time was 290 working days. Standard operating procedures (SOPs), review templates and an electronic submission tracking system are in place, but the GRevP framework is still evolving.Conclusion: Based on the available resources and capabilities, the SFDA is unable currently to meet its overall target timelines, partly due to the sponsor’s time in responding to agency questions. Therefore, it either needs to increase its resources or to implement a risk stratification system based on the Singapore model, which takes into account reviews by reference agencies. The SFDA is encouraged to develop GRevP guidelines to ensure the quality of the review. © 2015, Springer International Publishing Switzerland.

Discover hidden collaborations