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41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

This workshop is designed to provide a solid foundation of Pharmacovigilance (PV) in Clinical Trials. It will introduce the most important terms and definitions, MedDRA (Medical Dictionary for Regulatory Activities) coding, SAE (Serious Adverse Event) management, unblinding processes, SUSAR (Suspected Unexpected Serious Adverse Reaction) submission, and a first glance at a PV database.

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

The purpose of this workshop is to introduce Pharmacovigilance (PV) in Post Authorisation. It will provide essential background knowledge on the origin of PV, sources for cases, case assessments in post authorisation, special situations, quality complaints, and case submissions
23-Apr-2019 - 23-Apr-2019

York, York, YO10 5DD, United Kingdom

This training day focusses on the development of economic models specifically in the area of oncology. The sessions will include overviews of the most common methods for modelling treatments for cancer, and will pay particular attention to the areas that prove most challenging in HTA, including survival curve analysis, data extrapolation, quality of life modelling (including adverse events), handling treatment discontinuation, modelling disease progression and post-progression model assumptions. The day will draw on examples from previous HTA submissions and will provide a number of recommendations for modelling frameworks. This course will be particularly suited to those people that commission oncology models. Please note that other more ‘hands-on’ modelling courses are run by the Univers…
29-Apr-2019 - 29-Apr-2019

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

In an increasingly cost-conscious health care environment, pharma companies must make a thorough case for not only the clinical, but also the economic value of their products. These days, clinical efficacy alone is not enough; both clinical effectiveness and 'value for money' are essential to make sure the product reaches the patients for whom it is intended. Course Topics Introduction to Market Access Landscape: Who are the Stakeholders and what are ytheir perspectives Health Outcome Assessment types Pricing Country systems

100-110, Euston Road, London, Greater London, NW1 2AJ, United Kingdom

Indirect treatment comparisons (ITC) and mixed treatment comparisons (MTC), collectively referred to as Network Meta-Analysis (NMA), are increasingly used in health technology assessment. They are statistical techniques to synthesise available direct and indirect evidence to provide information on the comparative effectiveness and safety of a range of competing interventions. Network meta-analyses are often complex and challenging projects to specify and undertake and bring with them a range of planning considerations that are critical for a successful end product. These considerations include specifying the review question, identifying relevant studies, deciding how to assess the similarity of studies in a potential network and developing the statistical analysis plan and using the NMA…

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

In modern global pharmaceutical companies it is becoming increasingly important for non-statisticians to understand the value and application of statistics in order to maximise the value of the data. This course is designed for professionals working in the pharmaceutical industry with no or little previous knowledge of Statistics as we start right at the beginning with the basics. It will be non-software focused, but rather understanding the basic statistical concepts, interpreting output and discussing how the knowledge can be applied and integrated efficiently into the job role.
14-May-2019 - 14-May-2019

York, York, YO10 5DD, United Kingdom

The Five Year Forward View in 2014 set out the challenges facing the NHS in England in the coming years, namely ensuring the ongoing delivery of high quality care for patients in the face of constrained funding and ever increasing demand. The same challenges exist in the rest of the UK and health care commissioners and providers are working out how to address these issues at national and local levels. The NHS needs to redesign the way in which services are provided and initiatives such as the New Models of Care Vanguard programme and Sustainability and Transformation Plans are in place to help with this. Many new service redesign initiatives are being piloted and rolled out across the UK. In making a case for service redesign, it is crucial that NHS providers and commissioners understan…

York, York, YO10 5DD, United Kingdom

Diagnostic test accuracy studies are receiving increasing attention, but are challenging to identify efficiently and reliably. As well as health care professionals seeking information on best evidence on test accuracy, there is also a growing requirement for systematic study identification to inform systematic reviews and technology assessments of diagnostic tests and techniques. The growing number of diagnostic test accuracy reviews is an important resource for the practice of evidence-based health care. This training day will provide an introduction to the key features of diagnostic test accuracy studies to provide insight into retrieval challenges. This will be followed by an overview of the research evidence on search approaches to identify diagnostic studies and the key current res…

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

This course is designed for those working/interacting with the vendors to deliver your clinical trials. How do you ensure you manage them to optimise your clinical trial delivery? What is required for compliant vendor oversight? What could put you at risk of inspection findings? Do you require a governance system with your vendors? How should you implement this for your outsourcing model and how will it add value? What is the best approach to maintain healthy business relationships when outsourcing? How do you drive performance transparency through use of metrics?

York, York, YO10 5DD, United Kingdom

Economic evaluations are increasingly used as tools to inform decision-makers about the cost-effectiveness of health technologies. Such evaluations are often undertaken during the late stages of the technology development (i.e. around the time of product launch or, in some cases, post-launch). However, there is an increasing need for the manufacturers of the technology to appraise the likely cost-effectiveness of the intervention before making decisions on price and indication, as well as to inform the development of clinical trials. The purposes of early economic modelling is to allow the user to determine the relative importance of different parameter inputs, in order to inform decisions on pricing, target populations and prioritisation of further research. This one-day training sessi…
03-Jul-2019 - 03-Jul-2019

York, York, YO10 5DD, United Kingdom

Cost-utility analysis is a requirement for NICE health technology appraisals and is being increasingly used in other contexts and countries. Health utilities, a crucial component of cost-utility analysis, capture the relative change in health-related quality of life resulting from a treatment. As such, health utility can be a key driver of the cost-effectiveness ratio. Obtaining health utility values that are suitable for your economic evaluation, however, may not always be straight forward. This one-day training course complements the early economic modelling course, discussing issues around different approaches to obtaining utility values. It introduces each approach in turn, giving an overview of the implementation, strengths, and limitations of each, across different contexts. Fu…

York, York, YO10 5DD, United Kingdom

Health economics evidence is a key element in much health services research and particularly in health technology assessments. Identifying economic evidence to inform such research can involve searches in a range of databases and using a variety of strategies. This study day will include a ‘jargon buster’ session on the basics of health economics and economic models. It will also feature presentations about key economics information resources including the CEA Registry, and explorations of options for searching to identify data for economic models. With the closure of key economic evaluation databases (NHS EED and HEED) we will be focusing on how to identify economic evaluations from major bibliographic databases. There will be opportunities for hands-on practice.

York, York, YO10 5DD, United Kingdom

This training day aims to provide the participant with a sufficient grounding to effectively critique and validate models. The training day will be particularly useful to those people who commission health economic models, or use models to help make decisions. As well as discussing the strengths and uses of economic modelling, the training day will also explore the limitations and constraints of different approaches and will explore a number of commonly-observed errors in models. Please note that this training day has not been designed to teach delegates how to build models; instead, the course is aimed at those who will review or depend on models built by other researchers.

York, York, YO10 5DD, United Kingdom

Extensive literature searches are the foundation of high quality systematic reviews, health technology assessment (HTA), guideline development and other major projects. Conducting searches to retrieve research evidence from databases and other resources requires a range of knowledge and skills. There are constant challenges to keeping up-to-date with new database features and approaches to achieving efficient searches. Search approaches may need to be adapted depending on the end-product which the search is informing and the resources available. Search approaches increasingly need to be explained to sponsors and other end-users in terms of the extent to which they are fit-for-purpose. This workshop will provide opportunities to learn new techniques, to discuss best approaches, to share…

York, York, YO10 5DD, United Kingdom

This course looks at how to design complex search strategies and complements our training on advanced search techniques. As the volume of published research grows it is becoming more challenging to identify efficiently studies performed according to specific methods or relating to broad topics. As well as increasing volumes of research, many research topics are complex and challenging to capture in search strategies. Examples of complex topics may include, but are not limited to, reviews of complex interventions, reviews requiring the identification of study designs other than RCTs, public health and social care topics, veterinary literature, food and feed safety research. Information professionals and others wishing to develop search strategies for complex topics face challenges in des…

York, York, YO10 5DD, United Kingdom

Systematic reviews can be time consuming, logistically challenging and labour intensive. These and other challenges have led to the development of various special-purpose software tools to support the systematic review production process. Such tools extend beyond the scope of more established general-purpose systems (e.g. reference managers, word processors and spreadsheet packages), which are already in wide use and, instead, aim to provide tailored support for particular review activities or the whole systematic review production process. This workshop will provide an opportunity to learn about special-purpose software tools currently available to support systematic reviews and to share experiences of using software in practice. The workshop will examine and provide hands-on with both…

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

The aim of this workshop is to ensure you gain a comprehensive understanding of the tools and techniques of project management and how they can be applied straight away to your own clinical research projects in the work place. The detailed aims are to: • Understand technical project management tools and techniques and apply these to your work • Examine the competencies appropriate for an effective project manager • Identify the project critical path and use this information to assist in planning decisions • Provide a better understanding of the essential personal skills which are necessary to achieve project objectives
24-Oct-2019 - 24-Oct-2019

41, Münchensteinerstrasse, Basel, Basel-Stadt, 4052, Switzerland

This course offers a thorough update of the current understanding and interpretation of Good Clinical Practice and practical guidance/advice on how to ensure readiness for Health Authority inspections, both of Sponsor and Investigator sites.

York, York, YO10 5DD, United Kingdom

As the demand for health and care services grows and finances become more constrained, there is an increasing need for economic evaluation in the public sector. NHS, social care and public health organisations are expected to be able to economically justify any changes in care pathways they propose and there are concerns not only around cost-effectiveness but also the affordability of new initiatives. Many public sector bodies are under pressure to achieve efficiency and productivity savings in order to balance budgets. They are seeking innovations that will reduce cost pressures and they need to understand the impact of changes in different sectors, including primary, community and social care as well as acute care. There is a focus on primary and secondary prevention approaches in pub…

Copenhagen, Denmark

This year, our annual Clinical NGS Data Analysis Nordic Workshop, led by the Bioinformatics team of Odense University Hospital (OUH), will take place in Copenhagen. The workshop will aim to go over the steps from acquisition of sequencing data to the generation of the bam- and vcf- files that will be used in the subsequent filtering for variants. Variants will be evaluated using various databases and prediction tools to establish potential pathogenic variants. Workshop delegates will be given tutorials and examples and will be expected to handle the data themselves on their own laptops. This workshop will be hands-on, so all delegates will need to bring their own laptop.  Full laptop requirements are Java 7 or 8, 4GB RAM and 10 GB of free hard disc space, Microsoft Excel and Internet…