At the Exploratory Clinical Trials event on 8-9 December 2009 in Brussels, Belgium you’ll have the opportunity to question the MHRA in person on the updated ICH M3 guidelines and find out how you can maximise your chance of easily gaining approval for your trials.
Innovation in Phase 1 Clinical DevelopmentElisa_Ramella
Practical app roaches to
phase I trial develop ment
to enable faster go / no -go
decision s, reduce co st and
speed time to market
www.phase1clinicaldevelopment.com
Розвиток тематичного туризму на прикладі «Карпатської мережі кулінарної спадщ...Viktor Zagreba
Презентація на Міжнародній конференції «Екологічний та природничий туризм: співпраця природоохоронних територій, туристичного бізнесу та місцевих громад» в м.Яремче 25-26 квітня 2014 року
Innovation in Phase 1 Clinical DevelopmentElisa_Ramella
Practical app roaches to
phase I trial develop ment
to enable faster go / no -go
decision s, reduce co st and
speed time to market
www.phase1clinicaldevelopment.com
Розвиток тематичного туризму на прикладі «Карпатської мережі кулінарної спадщ...Viktor Zagreba
Презентація на Міжнародній конференції «Екологічний та природничий туризм: співпраця природоохоронних територій, туристичного бізнесу та місцевих громад» в м.Яремче 25-26 квітня 2014 року
The Clinical Trial in Oncology event on 1-2 December 2009 in Munich will show you how to utilise target approaches to optimize your clinical research and enhance your patient enrolment, data quality and much more.
2nd Annual Bioequivalence and Bioavailability Studies 2011 - AgendaPharma IQ
2nd Annual Bioequivalence and Bioavailability Studies - Full Agenda
LEARN MORE
http://www.bioequivalenceevent.com/redForms.aspx?id=532198&pdf_form=1?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
P 058 Advances And Progress In Drug Designkprior88
SMi\'s 12th Annual Drug Design Conference will present attendees with an in-depth view into the developments and challenges within the Drug Design field
Adaptive Clinical Trials will enable you to access new case studies and learn from the experiences of the increasing number of major pharma companies who have embarked on adaptive trials. The event is split into two streams in order to provide in-depth, targeted information for both a clinical and a statistical audience and is relevant across all therapeutic disciplines. The event will cover topics such as trial design, the practical implications of making an adaptation on the supply chain, along with data collection and analysis. There will also be extensive coverage and opportunities for debate on the latest industry guidelines.
If you are looking into using adaptive trials, would like to expand your knowledge, or are experienced in adaptive trials and would benefit from discussing key industry and regulatory developments with your peers, this a must attend event.
The event will consist of:
An update from the regulators on the latest guidelines and an appraisal of what they look for in adaptive design
A broad range of case studies from across all phases and therapeutic areas to give you an in depth knowledge of what is working and what isn’t
Carefully researched round table discussions designed to focus on the key questions you have about adaptive trials, their design and execution
An examination of the business case for adaptive trials. Do they save time and money?
2nd Epigenetics Discovery congress - Latest agendaTony Couch
Advancements in Epigenetics have certainly given us huge breakthroughs in drug discovery, development and effective diagnosis of diseases. Scientists are working towards making new developments and address challenges in epigenetics for cancer, neurodegenerative diseases and other ailments. The Epigenetics Discovery Congress will provide a platform to such scientists to present their work, learn what their peers are doing, share experiences and overcome challenges that the industry is facing.....
SMi’s 17th annual Pain Therapeutics conference will hone in on the latest innovations and novel approaches to pain therapy and analgesic drugs as well as look at the practicalities of using animal models and translational biomarkers in pain research. Aimed at an audience of senior specialists in neurology, CNS, clinical sciences and pharmacology, Pain Therapeutics 2017 will keep attendees at the forefront of scientific breakthroughs to adapt to the growing need towards minimising opioid dependency and new drug discovery. Presentations from a selection of leading pharmaceutical companies currently developing novel analgesic treatments including Nektar Pharmaceuticals, Janssen, MSD USA, Grunenthal GmbH, Lilly UK and Mundipharma, will provide delegates with an understanding on key topics such as product formulation; opioid addiction; translational pain research; and breakthroughs in drug discovery.
Tumour models London 1-3 December 2015 AgendaDiane McKenna
Tumour Models London 2015, now in its 4th year,is the leading meeting dedicated to improve preclinical predictability and translational success of oncology discoveries. Tackling clinical failures rates, preclinical strategies and translational challenges, this Summit will enable you to translate your discoveries from model to human studies with superior predictability to future proof clinical success. [Read More…]
This is a slide show, with notes, about the CMTA's STAR initiative, created by Dana Schwertfeger and myself. It is to enhance your understanding of the CMTA's research STAR project and bring you up to date on recent news. Enjoy!
SMi’s 10th annual conference on Clinical Trials in CNS will bring together leading industry experts to explore the current and future opportunities within CNS drug development. With 35% of the global disease burden due to CNS disorders, this event addresses a vital area of research.
New Build Europe 2010 will provide a platform for you to discover upcoming technologies and effectively shape your project development/management strategies.
The efficiency and profitability of coal and gas power plants is a major issue at the minute, with Utilities actively scrutinising these in their new build plans. Plus the challenges of effective operation is beginning to be a key focus, with the procurement of quality products and scheduling coming to the fore.
This conference will fully cover these areas and show you how they affect your business strategy. It will also focus on clarifying investment and lifespan issues particularly with coal plants and show how to integrate fossil and renewable energy in the long-term.
Revenue Assurance, Fraud Reduction and Cost Managment in Telecoms ConferenceArena International
Revenue Assurance, Fraud Reduction and Cost Management in Telecoms 2010 offers practical and effective strategies you can implement in your business to optimise revenue assurance and control costs. Building on the feedback from our successful 2009 event, the 2010 conference features more case studies from operators, VMNOs and ISPs than ever before, and a new focus on combating telecoms fraud.
Held on the 11 and 12 May 2010 in London is the biggest and most eagerly anticipated conference in the EMEA, and will bring together key industry experts to provide answers to current topical questions. From coping with the global economic recession and effectively controlling roaming revenues to limiting bad debt, this conference will provide insight on how to solve the critical issues that you face in the industry today.
The Clinical Trial in Oncology event on 1-2 December 2009 in Munich will show you how to utilise target approaches to optimize your clinical research and enhance your patient enrolment, data quality and much more.
2nd Annual Bioequivalence and Bioavailability Studies 2011 - AgendaPharma IQ
2nd Annual Bioequivalence and Bioavailability Studies - Full Agenda
LEARN MORE
http://www.bioequivalenceevent.com/redForms.aspx?id=532198&pdf_form=1?&shownewswindow=1&utm_source=PharmaIQ&utm_medium=SMO&mac=PMIQ_Slideshare&utm_campaign=Slideshare&utm_term=pdf
P 058 Advances And Progress In Drug Designkprior88
SMi\'s 12th Annual Drug Design Conference will present attendees with an in-depth view into the developments and challenges within the Drug Design field
Adaptive Clinical Trials will enable you to access new case studies and learn from the experiences of the increasing number of major pharma companies who have embarked on adaptive trials. The event is split into two streams in order to provide in-depth, targeted information for both a clinical and a statistical audience and is relevant across all therapeutic disciplines. The event will cover topics such as trial design, the practical implications of making an adaptation on the supply chain, along with data collection and analysis. There will also be extensive coverage and opportunities for debate on the latest industry guidelines.
If you are looking into using adaptive trials, would like to expand your knowledge, or are experienced in adaptive trials and would benefit from discussing key industry and regulatory developments with your peers, this a must attend event.
The event will consist of:
An update from the regulators on the latest guidelines and an appraisal of what they look for in adaptive design
A broad range of case studies from across all phases and therapeutic areas to give you an in depth knowledge of what is working and what isn’t
Carefully researched round table discussions designed to focus on the key questions you have about adaptive trials, their design and execution
An examination of the business case for adaptive trials. Do they save time and money?
2nd Epigenetics Discovery congress - Latest agendaTony Couch
Advancements in Epigenetics have certainly given us huge breakthroughs in drug discovery, development and effective diagnosis of diseases. Scientists are working towards making new developments and address challenges in epigenetics for cancer, neurodegenerative diseases and other ailments. The Epigenetics Discovery Congress will provide a platform to such scientists to present their work, learn what their peers are doing, share experiences and overcome challenges that the industry is facing.....
SMi’s 17th annual Pain Therapeutics conference will hone in on the latest innovations and novel approaches to pain therapy and analgesic drugs as well as look at the practicalities of using animal models and translational biomarkers in pain research. Aimed at an audience of senior specialists in neurology, CNS, clinical sciences and pharmacology, Pain Therapeutics 2017 will keep attendees at the forefront of scientific breakthroughs to adapt to the growing need towards minimising opioid dependency and new drug discovery. Presentations from a selection of leading pharmaceutical companies currently developing novel analgesic treatments including Nektar Pharmaceuticals, Janssen, MSD USA, Grunenthal GmbH, Lilly UK and Mundipharma, will provide delegates with an understanding on key topics such as product formulation; opioid addiction; translational pain research; and breakthroughs in drug discovery.
Tumour models London 1-3 December 2015 AgendaDiane McKenna
Tumour Models London 2015, now in its 4th year,is the leading meeting dedicated to improve preclinical predictability and translational success of oncology discoveries. Tackling clinical failures rates, preclinical strategies and translational challenges, this Summit will enable you to translate your discoveries from model to human studies with superior predictability to future proof clinical success. [Read More…]
This is a slide show, with notes, about the CMTA's STAR initiative, created by Dana Schwertfeger and myself. It is to enhance your understanding of the CMTA's research STAR project and bring you up to date on recent news. Enjoy!
SMi’s 10th annual conference on Clinical Trials in CNS will bring together leading industry experts to explore the current and future opportunities within CNS drug development. With 35% of the global disease burden due to CNS disorders, this event addresses a vital area of research.
New Build Europe 2010 will provide a platform for you to discover upcoming technologies and effectively shape your project development/management strategies.
The efficiency and profitability of coal and gas power plants is a major issue at the minute, with Utilities actively scrutinising these in their new build plans. Plus the challenges of effective operation is beginning to be a key focus, with the procurement of quality products and scheduling coming to the fore.
This conference will fully cover these areas and show you how they affect your business strategy. It will also focus on clarifying investment and lifespan issues particularly with coal plants and show how to integrate fossil and renewable energy in the long-term.
Revenue Assurance, Fraud Reduction and Cost Managment in Telecoms ConferenceArena International
Revenue Assurance, Fraud Reduction and Cost Management in Telecoms 2010 offers practical and effective strategies you can implement in your business to optimise revenue assurance and control costs. Building on the feedback from our successful 2009 event, the 2010 conference features more case studies from operators, VMNOs and ISPs than ever before, and a new focus on combating telecoms fraud.
Held on the 11 and 12 May 2010 in London is the biggest and most eagerly anticipated conference in the EMEA, and will bring together key industry experts to provide answers to current topical questions. From coping with the global economic recession and effectively controlling roaming revenues to limiting bad debt, this conference will provide insight on how to solve the critical issues that you face in the industry today.
The Oil & Gas Technology Forum Drilling Day event, located in London, will provide a platform for you to hear brand new caste studies on how the oil industry can work together to enhance profits, learn valuable strategies from top-level speakers on maximising resources as well as unlimited access to network with peers and leading experts.
Network and listen to leading experts such as Tue Hassenkam, Associate Professor, NanoGeoScience, UNIVERSITY OF COPHENHAGEN, John Corben, Senior Technical Advisor, IEA, Giovanni Botto, R&D Manager Drilling, ENI SPA and more!
Make sure you register now – the first 5 registrations get automatic places at the invite-only Oil & Gas Technology Forum on 26th & 27th March
VIBpharma is delighted to announce the 3rd Annual Competitive Intelligence in Pharma USA conference, April 13-14, 2010 in Philadelphia. CI USA continues our 12 year global series which has seen some of the largest gathering of Competitive Intelligence professionals from the pharma and biotech industries. Register now to reserve your place!
Now in its 20th year the industry renowned PLIM & PLEX conference makes a welcome return to Europe. This leading industry event, developed with industry experts and in association with Nuclear Engineering International and Modern Power Systems, will bring together a series of international case studies focusing on the development of an efficient plant life management strategy and an effective approach to licence extension
With the leading nuclear experts, PLIM specialists, consultants and technology providers this is an event not to be missed with unparalleled networking and discussion opportunities.
Our 2nd Annual Pharma Packaging & Labeling Conference brings together very senior industry experts from the leading pharma companies, from multinationals to innovative biotechs, to really drill down strategy options for both packaging and labeling that will be affordable to implement, ensure regulatory compliance and help to drive profitability.
VIBpharma’s Clinical Trials in Emerging Markets conference will bring together pharma and biotech companies to share solutions to strategic and operational challenges in setting up and conducting studies in new territories. Attendees will hear from experienced professionals who will share their knowledge on making the most of the opportunities and benefits of conducting trials in emerging markets. Attend this practical, insightful and solution led event to generate new cost and time saving ideas for your clinical trials.
VIBpharma’s Clinical Trial Supply conference brings together senior representatives from pharma and biotech manufacturers to discuss key issues through a series of high caliber presentations and interactive roundtable discussions led by industry experts. The topics being addressed will also include innovative drug mobility and labelling strategies, getting the most out of your IVRS, ensuring compliance across Europe, best practice approaches for temperature controlled transportation.
Join us in London in February to discover practical approaches for ensuring a cost-efficient clinical supply chain.
Join us for this respected and senior-level conference taking place in London on Tuesday 9 and Wednesday 10 March 2010, to network with your peers and uncover tried-and-tested solutions to these and other critical issues you face.
With country case studies and presentations from industry figureheads involved in new nuclear build and construction, can you afford to miss out?
Arena Internationals’ Operations & Maintenance Strategies for Coal & Gas Power Stations being held on 18th and 19th March in London, UK, aims to establish solutions to key issues such as:
The impact of future government legislation on your O&M strategies
Executing the best O&M strategies to ensure your plant’s life is extended
The impact of carbon capture on your power station - case study on a CCS pilot plant
How to make your plant more flexible by understanding how to implement successful optimisation techniques
Through case study driven presentations from leading energy operators and a series of informative panel debates, this event will provide you with best practice solutions to help you comply with existing and upcoming challenges in the market.
If you’re involved in small hydro, you need to be at Small Hydro. Why?
Over 14 case studies from leading IPPs, utilities and developers – find out how to overcome the challenges they faced and get first-hand experience of how to meet obstacles in your own operations
12 countries represented - whether your small hydro interest is multi-national or community focussed, uncover new opportunities and learn about new techniques from experts around the world
A special focus on licensing, regulations and permitting – with so many complex processes affecting the licensing of your project, make sure you are up to date with changing regulation and expectations
Funding Masterclass – Make sure you’re positioned to benefit from upcoming opportunities and avoid funding pitfalls at this dedicated session
An overview of some of the newest and most exciting technologies in the industry. Find out what will save and what will make you money in plant efficiency
Gain a new perspective on your challenges through input and feedback from government bodies and leading international organisations
Make the most of over 12 hours of networking, including roundtables, drinks and dinner to meet with your peers and share ideas on a one-to-one level
Following on the success of our 3rd Biosimilars conference VIBpharma is proud to announce the 4th annual Biosimilars conference taking place on Tuesday 16 and Wednesday 17 March 2010 in Brussels, Belgium.
Through a series of presentations and interactive discussions covering key issues such as current market trends, biobetters, the global regulatory environment, pricing and reimbursement strategies and biosimilars in emerging markets, participants will gain new insight and share hands-on experiences with leading companies in the pharma and biotech industry.
VIBevents’ 7th Annual Cold Chain Storage and Distribution conference will bring together key manufacturers and industry experts to discuss these amongst other core issues. From understanding key transport, packaging, validation and qualification methods to optimising strategies for storing biotech and pharma products, this event will provide a platform to debate best practice approaches.
Once again, this event will be co-located with our established Clinical Trial Supply event in order to provide you with more opportunities to interact and exchange ideas with peers from both backgrounds.
Following the success of this conference series, Arena International’s 6th Annual Fire Protection of Rolling Stock conference will be held on Tuesday 24th – Wednesday 25th March 2010 in London. The event will establish strategic solutions and highlight new technologies to enhance fire protection of railway vehicles. Through a series of best practice presentations and case studies, this event will provide you with insight into railway operator and rolling stock manufacturer approaches as well as presentations from regulatory authorities to current and upcoming fire safety issues.
Global Asset Security: Oil and Gas gives you the opportunity to hear from security experts with specific expertise in security threats around the world and across the US. You will have the chance to share knowledge and experience on common or industry challenges such as ensuring the safety of your personnel, and maximizing the robustness of your product supply chain in order to reduce your financial and physical vulnerability.
Attendance at Global Asset Security: Oil and Gas 2010 is essential for anyone involved with developing security strategy or running the security program either in the US or abroad
At a strategic level, The event will address the increasing need for security to be more effectively and efficiently integrated into overall business strategy, and how you can effect such integration in your business. How can you minimize the effect of budget constraints on your security programs? To what extent is your intellectual property safe and how can you improve your defense against financially damaging security breaches?
Key benefits of attending Global Asset Security: Oil and Gas 2010
Understand the business models and security trends that are driving the industry
Discover how TWIC and CFATS regulations can be efficiently assimilated into your business plan in order to ensure compliance and maximize effectiveness
Evaluate the changes in criminal strategy and uncover the true costs (and benefits) of implementing solutions
Reduce your loses and improve your safety record by creating the best possible offshore security program
Get the competitive edge- learn to maximize ROI from your security investments
Get critical insights into the real changes in global security in the regions where you have an interest
The market for mobile banking and other mobile financial services is growing at an ever increasing rate, with customer adoption in the US set to grow to 56 million users in the next few years. Institutions that have led the way are already seeing customer loyalty, return per customer and customer acquisition benefits.
The question now is not if I should enter this market, but how do I compete in the mobile banking space?
Mobile Financial Service Congress, 2-3 December, Miami, Florida, will provide critical insights to overcome technical and budgetary challenges, and winning strategies for fully exploiting the mobile channel.
With both the Rail and the Road authorities imposing increased tunnel safety standards, those working in the industry must invest to meet mandatory requirements or risk being excluded. The upside comes from the still very lucrative gain that is available in the industry and the high potential return for forward looking companies that can excel in this area.
With guidance needed on how to accomplish compliance by means of maximum efficiency and minimal expenditure, the first annual Fire Protection and Safety in Tunnels conference is being held in Paris, 17-18 Nov 09 to help you meet industry safety standards, optimise your risk management and achieve safety excellence.
Developing an effective yet transparent pharmacovigilance strategy and keeping ahead of regulatory changes can be challenging, yet the EU’s complex safety regulations and ever-increasing media attention make both functions vital.
At VIBpharma’s 5th annual Pharmacovigilance and Risk Management conference you will gain solutions to the issues you are currently facing; from the difficulties with RMP’s and how to effectively manage risk management with current medicines to mitigate any risks to patients.
The overall goal of your data management model is to capture quality data in a timely and cost efficient method. However, instituting and complying with upcoming CDISC standards can be challenging especially with existing trials.
To prepare you for these regulation changes, VIBpharma has brought together industry experts to answer all of your questions and provide you with solutions to ensuring a seamless integration of the CDISC standards.
Renewable energies are an extremely under used resource throughout Europe, a major reason for this is because, there is currently nowhere for this perishable power to be stored. However, Arena International’s Energy Storage Solutions conference will bring together the key players, latest research and leading solution providers to enable you to overcome the critical challenges of the European energy storage market.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
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to deliver case study driven UcB NEW mEDiciNES (OSi) PROSiDiON UK
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MHRA about the new ICH M3 Section head of human BiOViTRUm SWEDEN
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Bruno Boulanger,
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Vice President, Associate Director
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networking opportunities mERcK USA Exploratory
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Department, ASTELLAS
JW mcBlane PhD, PhARmA GLOBAL
Senior Pre-Clinical Assessor, DEVELOPmENT EUROPE
TOP cOmPANiES REPRESENTED iNcLUDE: mhRA UK NEThERLANDS
• UCB • BOEHRINGER INGELHEIM
Erik mannaert, Director
• HOFFMANN LA ROCHE • NOVARTIS Dr. håkan Wennbo, Clinical Pharmacokinetics,
• BAYER • FAMHP Global Project Director, J & J PhARmAcEUTicAL
• MHRA • ASTELLAS Cardiovascular & R&D (a Division of Janssen
Gastrointestinal, Pharmaceutica N.V.)
• ASTRAZENECA • JOHNSON & JOHNSON
ASTRAZENEcA SWEDEN BELGiUm
Sponsors:
Register online now at: www.clinicaltrialsevents.com/exploratory
2. Programme Day One Tuesday 8 December 2009
08:30 Registration ● Linking therapeutic concepts to diseases successfully
● Uncovering a comprehensive evaluation of pharmacodynamic actions
09:00 Opening remarks from the chair to maximise study success
Dr. Thomas Senderovitz, Vice President Global Exploratory ● Identifying the best organisational solutions for integrated R&D
Development, UcB NEW mEDiciNES BELGiUm Prof. Johan Luthman, Vice President, Neuroscience R&D, mERcK USA
Looking into the crystal ball: forecasting the future 12:10 case study:
of the pharmaceutical industry connecting the dots from the pre-clinical phase to
the probability of success: making it a reality through
09:10 Keynote:
the integration of Bayesian statistics
changing the game: a look into the future of Research ● Outlining how to turn information generated in pre-clinical phases
and Development (R&D) in the pharmaceutical industry into direct value
● How can pharma R&D change and become more productive? ● Indicating how modelling is used to improve efficiency of exploratory
● What will the future pharma-healthcare landscape look like? trials through the use of adaptive designs, optimal designs or
● Why is this relevant for you – translational and exploratory Bayesian modelling
medicine experts? ● Introducing prediction-based decision-making and demonstrating the
Dr. Thomas Senderovitz, Vice President Global Exploratory new added value for clinical trials: improving predictions
Development, UcB NEW mEDiciNES BELGiUm ● Using assay performance knowledge to improve clinical trial performance
Giving a broad Bayesian modelling perspective on exploratory
maximising the efficiency of ADmE and PK properties
●
development
to improve the translatability into the clinic Dr. Bruno Boulanger, Director Exploratory Statistics,
UcB PhARmA BELGiUm
09:40 Best practice strategies for the prediction of ADmE
properties in humans from preclinical data 12:40 Effectively overcoming the challenges in Fih studies in
● Using human in vitro data versus animal studies to ensure data accuracy order to maximise study success
● Outlining the role of transporters in human drug disposition to ● Choosing a safe starting dose to ensure compliance with
maximise precision national regulations
● Accurately assessing drug metabolism and the potential role of ● Outlining tools and techniques to maximise the success rate through
metabolites in assessing efficacy and safety the use of practical examples
● Identifying the differences between small molecules and biologics ● Flexible, data driven protocol design to combine SAD and MAD in
Edis Travancic, Director, Pharmacokinietics and Bioanalysis, FIH studies
BiOViTRUm SWEDEN ● Debating if patients in other therapeutic areas to oncology can be
included in FIH studies
10:10 Determining human ADmE/PK early in clinical drug
● Phase 0 microdosing studies – do we really need labelled compounds?
development to forecast and ensure study success Dr. James Dow PhD, Director of clinical Pharmacology and DmPK,
● Running human Phase 0 microdosing studies – debating the (OSi) PROSiDiON UK
pro’s and con’s
● Meeting the US FDA ‘MIST’ guidance using innovative protocol 13:10 Lunch
designs to ensure regulatory compliance
● Determining absolute bioavailability and IV PK without extensive 14:10 Optimising the design of early Phase i studies to
preclinical studies achieve Poc faster
● Is there a new paradigm for determining human PK? ● Selecting appropriate populations to conduct successful early
Prof. colin Garner, molecular Epidemiology, Department of Biology, Phase I studies
UNiVERSiTY OF YORK UK ● Outlining different model based approaches to achieve PoC faster
● Maximising efficiency of PoC and proof-of-mechanism (PoM) studies
10:40 Morning refreshments to improve translatability
Achieving better informed dose selections
Overcoming the challenges of personal medicine
●
michael Derks, metabolic Disease Area clinical Pharmacologist,
and patient selection by utilising selection and hOFFmANN-LA ROchE SWiTZERLAND
diagnostic tools
highlighting the role of animal models in
11:10 case study: translational medicine and how exploratory
Using pre-clinical data to facilitate the development
of patient selection tools
studies benefit
● Maximising the identification of patient populations for personalised 14:40 case study:
healthcare by utilising molecular diagnostics The role of translational medicine in exploratory
● Increasing the likelihood of robust identification of those patients development and its impact on exploratory studies
who would benefit from treatment by using pre-clinical data from ● Exploring the mechanisms of action and potential importance of new
in-vitro systems and samples from undosed volunteers discoveries though effective experimental medicine
● Debating reproducibility, robustness, evaluability, translation and ● Utilising biomarkers to detect drug effects in man and to demonstrate
interpretability as key properties amongst others pharmacological activity and the mechanism of action of novel drugs
● The implications of these inputs for the design of the clinical ● Ensuring a better understanding of the disease mechanism by
programme will be discussed increasing the investment in clinical target validation and by
chris harbron, Technical Lead Statistician, Discovery Statistics, performing more exploratory studies
ASTRAZENEcA UK ● Improving the targeting of new drugs to increase the overall success
rates and the benefits of new drugs for patients
connecting the dots between pre-clinical and first Dr. håkan Wennbo, Global Project Director, cardiovascular and
in human (Fih) studies to maximise the success of Gastrointestinal, ASTRAZENEcA SWEDEN
exploratory studies 15:10 Afternoon refreshments
11:40 Overcoming strategic and technical challenges in bridging
the gap between animal and human pharmacology
● Outlining the need for high translational value of data to support
major transitions
3. Day One Tuesday 8 December 2009 Day Two Wednesday 9 December 2009
Enhancing the identification and validation of 08:30 Registration
biomarkers as a means of reducing costs and 09:00 Opening remarks from the chair
maximising trial outcomes Dr. James Dow PhD, Director of clinical Pharmacology & DmPK,
(OSi) PROSiDiON UK
15:40 Accelerating early clinical development utilising
predictive biomarkers 09:10 Roundtable morning
● Finding the right mechanism of action and Proof-of-Mechanism Delegates will be able to attend three one-hour roundtable discussion
(PoM) of biomarkers to filter out compounds that fail to show groups from a selection of key topics. Each session will be chaired
efficacy in humans by an industry expert who will facilitate an exchange of opinions,
● Speeding the development of biomarkers to the status of essential experiences and learning related to a current aspect of
true surrogates exploratory clinical trials.
● Identifying approved biomarkers as guidance for future approvals
● Case study projects in metabolics Roundtable 1
Dr. Arne Ring, Team Leader Phase i – iia Statistics,
BOEhRiNGER iNGELhEim GERmANY Overcoming the challenge of developing biomarkers
for personalised exploratory clinical trials to improve
16:10 case study: study outcomes
Biomarker development, validation and Discussing critical issues in the development of biomarkers to ensure
implementation from early development to translatability in personalised clinical studies.
clinical studies chris harbron, Technical Lead Statistician, Discovery Statistics,
● Applying PoM, Proof-of-Principle (PoP) and PcC biomarkers in early ASTRAZENEcA UK
development phases to define the correct dosage for healthy subjects,
e.g. FIH and patients Roundtable 2
● Debating biomarkers in early development – values and pitfalls to Exploratory clinical studies as the link between
improve future development pre-clinical and patient studies: how to design Fih,
● The incidence of adverse events in early Phase I – can this be predicted
through the use of biomarkers?
experimental medicine and exploratory studies to
● Outlining the regulatory environment for identifying approval biomarkers gain maximum knowledge
Dr. michael-Friedrich Boettcher, Global clinical Pharmacological Understanding the pros and cons of using patients versus
Project Leader, BAYER SchERiNG PhARmA AG GERmANY healthy volunteers for Phase 0 studies – focusing on scientific,
operational and ethical issues.
Evaluating the potential of exploratory studies Dr. heidemarie Kletzl, clinical Pharmacologist, PDEP clinical
Pharmacology, hOFFmANN-LA ROchE SWiTZERLAND
for biologics
16:40 Opportunities for biologics using exploratory Roundtable 3
clinical trials maximising the exploratory PK and PK/PD
● Identifying optimal trial design for biological exploratory studies investigation in early clinical oncology trials
to achieve go/no-go decisions faster Identifying efficient strategies to measure PK/PD in order to achieve
● Understanding the pros and cons of using patients versus a go/no-go decision faster using oncology trials as an example.
healthy volunteers for Phase 0 studies - scientific, operational Ludy can Beijsterveldt, Director, clinical Pharmacokinetics,
and ethical issues clinical Pharmacology, J & J PhARmAcEUTicAL R&D (a Division
● Optimising safety testing methodologies to assure legislative and of Janssen Pharmaceutica N.V.) BELGiUm
safety compliance
● Debating the potential of using adaptive trial design in early phase Roundtable 4
studies to speed up clinical trials
Dr. Jennifer Sims, Director head NBx Translational Sciences and Translational PK /PD for the design of dosing
Services, NOVARTiS PhARmA AG SWiTZERLAND strategies with monoclonal antibodies
Understanding the role of monoclonal antibodies and how the
17:10 closing remarks from the chair improve the translatability and dosage formulations.
Dr. Stephan Formella, Section head of human clinical Pharmacology,
17:15 close of Day One BOEhRiNGER iNGELhEim GERmANY
Roundtable 5
Predicting human PK - a problem solved?
Debating if animal studies can accurately predict human metabolism
to obtain consensus on the way forward.
Prof. colin Garner, molecular Epidemiology, Department of Biology,
UNiVERSiTY OF YORK UK
Roundtable 6:
Understanding the regulatory environment to
overcome hurdles and challenges
Learning how to overcome regulatory hurdles while setting up
exploratory studies to ensure regulatory compliance
Walter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation,
coordinator Early Phase Development, FEDERAL AGENcY FOR
mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm
12:30 Lunch
REGISTER ONLINE NOW!
www.clinicaltrialsevents.com/exploratory
4. Sponsors
Day Two Wednesday 9 December 2009 cmed provides CRO services and unique
clinical data technology. Services
include: clinical project management and
Reviewing the ich m3 guidelines and their impact monitoring, data management (eDC/paper) and statistical services.
on exploratory studies Cmed is rapidly gaining a reputation for leadership in the adaptive
13:30 Keynote: The mhRA’s approach to exploratory trial design community through its unrivalled ability to conduct
clinical trials and the ich m3 guidelines: complicated adaptive design studies using patented intelligent data
ensuring faster approvals acquisition/management (iDAM) technology. As Cmed combines
● Defining an exploratory clinical trial and outlining the rising both CRO services and technology within a single organisation it
importance of exploratory studies can execute these studies particularly efficiently without sponsors
● The MHRA’s approach to assessing applications for exploratory to coordinate multiple service providers. www.cmedresearch.com
clinical trials
● ICH M3 and how to maximise your chance of receiving an approval Exhibitors:
for an exploratory clinical trial
● Regulatory perspective of the impact of exploratory clinical trials
on drug development
● Recent experience and future trends for exploratory clinical trials
JW mcBlane PhD, Senior Pre-clinical Assessor, mhRA UK
media partners
The regulatory environment – different angles
Pharmaceutical Technology is
and approaches to ensure regulatory compliance used daily as a means of creating
14:00 Reviewing the regulatory environment for exploratory partnerships and as a point of
studies – FAmhP’s point of view reference by professionals within the pharmaceutical industry.
● Ensuring a balance between regulatory flexibility and stringent This comprehensive resource supplies the latest news releases,
regulations to ensure patient safety detailed information on industry projects, white papers, event
● Maintaining collaborations with the different parties to achieve information and a thorough breakdown of products and services.
global standardisation www.pharmaceutical-technology.com
● A statistical overview of exploratory study approvals in Belgium
● Forecasting future trends of regulatory approval numbers
Drug Development Technology is a
Walter Janssens, PhD, Senior Preclinical Assessor, Preauthorisation,
coordinator Early Phase Development, FEDERAL AGENcY FOR procurement and reference resource
mEDiciNES AND hEALTh PRODUcTS (FAmhP) BELGiUm providing a one-stop-shop for
professionals and decision makers within the drug development
Optimising exploratory studies with an adaptive and medicines industry. We provide a comprehensive breakdown
trial design and operational excellence strategies of drug development contractors and suppliers, up-to-date news
and press releases, white papers and detailed information on
14:30 Adaptive trials in early development current industry projects and trends. Our recruitment area provides
● Why early development is a good setting for adaptive clinical trials
career information and the latest job vacancies in the field.
● Which early development trials are most suited for adaptive clinical trials
● Finding the balance between statistical rigor and practical feasibility www.drugdevelopment-technology.com
● What to worry about when considering a adaptive trial
● Simulation as a indispensable tool to assess performance and The Business Review websites are
feasibility at the design stage your number one stop for all the
Filip De Ridder, Director, Biostatistics & Programming, latest news, comment and industry information. Each Business
JOhNSON & JOhNSON PhARmAcEUTicA R&D Review website offers content that is produced by a dedicated
team of journalists and global industry experts. In addition to the
15:00 Afternoon refreshments
free content made available on the sites an intelligence store will
15:30 Efficiency measures in the conduct of exploratory provide you with premium market analysis reports from the leading
development studies to ensure operational global suppliers of market research and industry analysis.
excellence in exploratory studies
● Focusing on operational excellence to maximise study efficiency Pharmaceutical Business Review is the
● Defining a clear roadmap to success through process world's leading pharma website, being
improvement strategies used by over 100,000 visitors every
● Measuring performance by metric strategies to identify weaknesses month. For further information contact
● Establishing and implementing cross departmental agreements for jsharp@industryreview.com
exploratory development studies
Gaby Anthonijs, Associate Director clinical Pharmacology, Exploratory
World Pharmaceutical Frontiers
Development Department, ASTELLAS PhARmA GLOBAL DEVELOPmENT
The pharmaceutical industry is
World Pharmaceutical Frontiers www.worldpharmaceuticals.net
EUROPE NEThERLANDS
changing fast. There are more
maximising exploraory study success by utilising regulations, technologies, faster product launches and shorter
product life cycles than ever before. World Pharmaceuticals
accurate simulation and forecasting tools
frontiers is, and will continue to be, at the forefront of these
16:00 case examples of physiological-based PK-modeling changes, so visit us at www.worldpharmaceuticals.net and stay
(PBPK) in early clinical development up to date with all latest developments
● Outlining the value of PBPK modeling to reduce uncertainty
Identifying PBPK-based methods as alternative for empirical allometric
●
scaling for the prediction of human PK. if you want to be a part of this
●
●
Improving the prediction of DDI’s (Drug-Drug Interactions)
Examining the prediction of dissolution-limited absorption in human
successful event, we have a number of
Erik mannaert, Director clinical Pharmacokinetics, J & J sponsorship opportunities available.
PhARmAcEUTicAL R&D (a Division of Janssen Pharmaceutica N.V.)
BELGiUm contact Nick mccudden to discuss your specific requirements
nicholasmccudden@arena-international.com or call
16:30 closing remarks and close of conference +4420 7753 4259
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2nd Annual Clinical Trials in Oncology, Tuesday 8 and Wednesday 9 December 2009, Munich, Germany
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