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30 THEME 8 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. children or between different paediatric age groups. They must be supported by a robust scientific rationale, and key assumptions must be confirmed by clinical data. Clinical data do not always confirm the original assumptions, and there have been cases where drugs that worked in adults didn’t work at all in children. An additional methodological challenge is the use and limitation of patient reported outcomes in clinical investigations in children. Bridging between Children and Adults in Paediatric Investigation Plans (PIPs) Maria Isaac, Scientific Administrator, European Medicines Agency, EU Expected and Unexpected Clinical Limitations in Bridging from Adults to Children Sam Maldonado, Vice President and Head Paediatric Drug Development Center of Excellence, Johnson & Johnson, USA Information Leveraging: Examining the basis for extrapolation Steven Hirschfeld, Captain, US Public Health Service, Associate Director for Clinical Research, National Institutes of Health, NICHD, USA Panel with Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EU 16:00-17:30 Session 0804 RISK MANAGEMENT FOR SPECIAL POPULATIONS Session Chair: Janet Hormbrey, Executive Director and EUQPPV, Merck Sharpe and Dohme, Belgium The Risk Management Plan as a tool to manage post - authorisation safety risk remains a relatively new tool. However experience is growing in the types of study required to further investigate known or potential risks or missing information, and the kinds of programs that can be utilised in Europe to manage known risks (risk minimisation).There remains little published experience to guide an author of risk management plans, and this is especially so in special populations. Special populations present special challenges and opportunities for the management of risk. Risks in children require attention to effects on long term growth and maturation, the explosion in the number of risk management plans in children and the difficulties of studying this population in long term randomised controlled trials mean that pharmacoepidemiological techniques will increasingly be required. Risk tolerance and the approach to pharmacoepidemiological studies for an NCE in cancer patients depend on the type, incidence and stage of cancer being treated. How best should you approach risk management for a cancer medicine? Risks to the foetus and pregnancy prevention remain perhaps the longest used and best described risk minimisation and management plans. However, substantial problems remain in such programs as they can be costly, restrict patient access and have demonstrated variable success. These evolving topics will be the subject of debate during this session. Risk Management in Cancer Patients Speaker invited Signal Detection in Paediatrics and Use of Observational Data to Assess Safety Miriam Sturkenboom, Professor of Pharmacoepidemiology, Erasmus University Rotterdam, Netherlands Pregnancy Prevention Programmes to Manage Risks in Fertile Women Ineke Crijns, Senior Clinical Assessor Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands FDA panelist invited Wednesday, 30 March 2011 09:00-10:30 Session 0805 CHALLENGES AND OPPORTUNITIES TO DEVELOP SUITABLE FORMULATIONS Session Chair: Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa Research- Based Pharm Companies, Germany The development of a suitable formulation is a thorough scientific process. The active ingredient might for example have characteristics which make it difficult to create an age adapted formulation. Since several excipients should not be used in paediatric formulations the process is even more complex if e.g. tastemasking is needed. At the end only technically high sophisticated formulations might be appropriate for certain age groups. Using these formulations for other patient populations such as e.g. elderly patients might be an option for a wider use of the required paediatric developments. Paediatric Formulations – Are they suitable only for children? Practical examples Agnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU Medicine Formulation Challenges in Neonatal and Paediatric Care Steve Tomlin, Consultant Pharmacist, Children’s Services, Evelina’s Children’s Hospital, St Thomas Hospital, UK Industry Perspective on Formulation Development in Special Populations Speaker invited 11:00-12:30 Session 0806 MEDICINES FOR GERIATRIC PATIENTS Session Chair: Solange Corriol Rohou, Director, Regulatory Affairs, AstraZeneca, France It is likely that Europe (EU) will face major challenges in relation to population ageing brought about by low fertility levels, improved medical and social care leading to longer life expectancy, and the baby-boom cohorts entering the age of retirement. Ensuring that medicines are labelled appropriately for the elderly is important and this means that they should be included in clinical studies where special ethical, safety and efficacy issues may arise. Information regarding the recent work of the CHMP and the European Medicines Agency in the area of geriatric medicines will be provided. Elderly Patients: An increasingly relevant patient population Simonetta Alvino, Medical Director, Pharmanet Development Group, Inc., Italy PREDICT Speaker invited Patient Perspectives Barbro Westerholm, Chair, Health Expert Group, and Representative at the European Medicines Agency, AGE, Belgium
THEME 8 | THEME 9 31 This is the advance programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 14:00-15:30 Session 0807/1307 HOW SHOULD THE PAEDIATRIC SCHEME BE AMENDED AND WHY? (JOINT WITH THEME 13) Session Chair: Angelika Joos, Director, Head Regulatory Policy, EU and Most of World, Merck Sharp & Dohme (Europe) Inc., Belgium The introduction of the Paediatric Regulation was celebrated as important public health milestone in 2006. Its implementation required a significant change in the drug development process and a mindset shift. Experience from industry during the first 3 years of operating under the new scheme will be presented. Concrete changes to current instruments will be suggested to address potential identified short comings in order to ensure that the Regulations’ objectives are effectively met. Reactions and perspectives from policy makers and regulators will complement the picture. Industry View of Paediatric Regulation Impact Ali Harrison, AstraZeneca, UK What changes would we need to address the findings? Genevieve Michaux, of Counsel, Covington and Burling, Belgium Does this Outcome Meet the Political Vision? European Commission speaker invited Panel with Agnès Saint-Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU 16:00-17:30 Session 0808 MEDICINES FOR PREGNANT AND LACTATING WOMEN Session Chair: Viveca Odlind, PDCO, MPA, Sweden Medicines usage during pregnancy and lactation is an important public health topic. Integration of animal and human data to assess the risks of the use of medicinal products during pregnancy is a critical task, which is aimed at reducing the induction of birth defects as far as possible. Integration of these assessments is essential for the labelling of a medicinal product. If available, clinical data from exposed breastfed infants should be mentioned as the conclusions of kinetic studies or non-clinical studies on the transfer of the active substance into milk should be provided. This session will also provide some perspective from the practical implications of collecting in use pharmacovigilance data. Use of Medicinal Products during Pregnancy and Lactation Klaus Olejniczak, Scientific Director, Department of Drug Toxicology, BfArM, Germany Data Gathering and Communication Tools to Improve Safe and Effective Use of Drugs during Pregnancy and Lactation – FDA perspectives FDA speaker invited Assessment of Safety of Medicines during Breastfeeding Eva Jirsová, Pharmacovigilance Unit, State Institute for Drug Control, Czech Republic Theme 9 | Pharma e-World Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France David Iberson-Hurst, CDISC Technical Architect, CDISC, UK The new pharma world of personalised and translational medicine, with its increasing integration of pharma R&D with healthcare, would not be possible without an ever increasing use of information technologies. This brings a number of drastic changes in processes, standards and tools, as well as the need to deal with the growing concerns of patients about the privacy of their health information. The purpose of this theme is to explore these different topics. Tuesday, 29 March 2011 09:00-10:30 Session 0901 USE OF ELECTRONIC HEALTH RECORDS FOR CLINICAL RESEARCH Session Chair: Isabelle de Zegher, Worldwide Senior Director Technology Integration & Data Standards, PAREXEL, Belgium Linking healthcare and clinical research is a topic we hear a lot about but why do we, as an industry, want to do this, what are the challenges and how close is the reality? In this session we will examine three initiatives, including the Innovative Medicines Initiative (IMI), and explore the key questions, the problems and when we might see production solutions. A View from Europe: The IMI EHR4CR Initiative Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability Standards, sanofi-aventis, France A Second European View: The Wellcome Trust Sintero Project Ed Conley, Co-PI Wellcome Trust Sintero Project, Distributed Collaborative Computing Research Group, Cardiff University School of Computer Science and Informatics, Severnside Alliance for Translational Research (SARTRE), Cardiff & Bristol University Schools of Medicine, Cardiff University, UK A View from the US: The CDISC healthcare link initiative Landen Bain, CDISC Liaison with Healthcare, USA 11:00-12:30 Session 0902 NEW APPROACHES TO PHARMACOVIGILANCE WHEN EMPLOYING ELECTRONIC HEALTH RECORDS (EHRS) Session Chair: Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk Management, European Medicines Agency, EU Optimising Adverse Event Reporting with the Electronic Health Record Marsha Laird, Senior Strategic Analyst, Cerner Corporation, USA EHR-Driven Safety Surveillance: The death of individual case safety reporting? Ambrish Mathur, Vice President, Strategic Development, Aris Global, USA
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