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The
Programme |
CVCTEC 2010 The globalisation of
clinical trials has meant that increasingly, pharmaceutical and
biotechnology companies are turning towards performing clinical trials
in emerging markets such as Asia Pacific, Central and Eastern Europe,
Latin America and the Middle East.
Within these emerging markets, the ability to research new products can also provide a way to maximize its potential use in countries typically not considered for commercial viability. However cultural, ethical, logistical and regulatory challenges can prove to be the biggest roadblocks when conducting trials in emerging countries and this is particularly true when conducting cardiovascular clinical trials. Cardiovascular Clinical Trials in Emerging
Countries focussed on the issues, problems and solutions of conducting
cardiovascular clinical trials in key emerging markets as well as
examining the challenges facing the pharmaceutical industry in pursuing
a contemporary approach in the development of drugs and treatment in
key areas. The highlights included: Conducting Cardiovascular Trials in CEE Countries and Central Asia. What have been the results, problems and solutions? • Regulatory affairs across CEE and Central Asia • Site selection. Pitfalls and potentials • Recruitment possibilities • Quality aspects. Governmental inspections • Data cleaning. Challenges and ways to overcome it Dr. Alexander Siebel (Germany) – Executive Scientific Adviser, S & P Pharmaterra
• The MHLW/PMDA has announced the implementation of ICH-E14 in Japan • Extrapolation of foreign data into Japanese subjects will be required for drug approval • The larger Asian community will have to adopt de facto similar cardiac safety standards Boaz Mendzelevski (UK) – Consultant Cardiologist, Cardiac Safety Consultants Ltd. and Member of FDA, EMEA, MHLW/PMDA ICH-E14 Expert Advisory Panel The Middle East: working within regulatory frameworks and accommodating FDA Audit. Maha Al-Farhan, (Saudi Arabia) – President & CEO, ClinArt International, and Founding Chair of the Gulf Cooperation Council Chapter of the Association of Clinical Research Professionals
• Eastern Europe – what makes it different? • An operating model for expanding to Eastern Europe • How to build your success in a new environment • Where to look for opportunities while minimizing the risk Jacek Nowak (Austria) – Executive Medical Director, Eastern Europe, Amgen Preparing for and surviving a regulatory inspection. • What will the inspectors be looking for? • Identifying your strengths and weaknesses • Practical preparation • How to be at your best • What to do if there are problems Dr Andrew Waddell (Scotland, UK) – Director, Tower Mains Quality Assurance (TMQA) and Chairman, British Association for Research Quality Assurance Implementing and executing cardiovascular clinical trials in South America • Clinical and practical characteristics of the region: epidemiological transition; facilities and technology; geographic location • Recruitment potential: private practice, hospitals, reference centres, specialized organizations • Regulations and timelines • Local knowledge as key for success in clinical trials Jorge Enrique Sáenz (Mexico), Regional Medical Director Cardiovascular and Metabolic Disease – Pfizer Latin America
• Analysis of sponsor and site data from TUFTS Center for the Study of Drug Development (Published February 2010) • Why Centralized Cardiac Safety results in better science, lower sponsor costs and more site convenience • The value to the sponsor and sites of a paradigm shift in Centralized Cardiac Safety • Cardiac Safety Yesterday versus Cardiac Safety Today John Blakeley (USA) – Executive Vice President, Sales & Marketing eResearch Technology (ERT) Cardiovascular monitoring in malaria studies; issues, solutions and quality control. • Getting quality ECG information from multinational multicentre studies in emerging countries presents several challenges • Proper training and a mixture of local and central review can achieve a high quality of ECG data • Issues regarding the misinterpretation of waveforms, rhythm and particularly QT interval can be resolved by the central review • Over reporting of abnormalities particularly from automatic readouts is not uncommon • Experience of Phase II and III clinical studies with >4000 patients in a recent malaria programme has demonstrated that all of these issues can be overcome and reliable ECG data obtained Dr. Robert Miller (UK) – Chief Medical Officer, Fulcrum Pharma. Why Latin America for Cardiovascular Clinical Research • Statistics (populations, distribution, trials per country) • Growth and trends • Case Studies • Cultural factors associated with clinical research in the region • Operational considerations Enrique Gaubeca (Argentina), Managing Director – Klixar Alternative funding options for pharmaceutical, biologic & device development in a challenging economy • Small and large molecule and device marketplace – current economic trends • Current R&D costs by therapeutic area • Extraordinary opportunities as current ‘blockbuster patents’ expire • Rising big Pharma R&D costs concurrent with shrinking pipelines • Pressure from generics, both small molecule and ‘follow on’ biologics • Capital mismatch between pipelines and resources • World is ‘on sale’ Big Pharma is buying at ‘fire sale’ prices • How might the approval change in 10 years? • Virtual drug development models • Funding options – Traditional big pharma equity, venture capital, CRO partnership, Hybrids Ross Tonkens (USA)– Consultant and former Vice President, Global Medical Affairs, MDS Pharma Services |
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