Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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22 Theme 3 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. Inconsistencies and Suggestions for Improvement Isabelle Stoeckert, Head of Regulatory Affairs Europe, Bayer Schering Pharma AG, Germany Tuesday, March 09, 2010 09:00 Session 0302 DESIGN AND CONDUCT OF ETHICAL PAEDIATRIC CLINICAL PROGRAMMES Session Co-Chairs: Sam Maldonado, Vice President and Head of the Pediatric Drug Development Center of Excellence, Johnson and Johnson, USA José Ramet, Professor, University of Antwerp, Chairman, Paediatric Department, Antwerp University Hospital , Belgium Paediatric investigation plans that meet the needs of the paediatric population, the regulatory environment and the commercial challenges are demanding. They consider quality, ethics and reliability of clinical research that are at the core of good paediatric development. Trial designs used for the adult population may include ethical and scientific issues that have to be reassessed to suit the paediatric perspective. Uniform standards will help to promote harmonised methods used for execution of such research. Paediatric networks may offer expert advice and support to facilitate patient enrollment and speeding up research to get new medicines to patients in need. Patient Perspectives on Ethics and Case Studies Speaker invited Standards for Research with Children (StaR Child Health) Hanneke van der Lee, Department Pediatric Clinical Epidemiology, Emma Children's Hospital Academic Medical Centre, the Netherlands Planning Clinical Trials in Paediatric Psychopharmacology – Results from a feasibility study Jonas Lundahl, Head of Section, H. Lundbeck A/S, Denmark 11:00 Session 0303 FOCUSING ON PHARMACOVIGILANCE AND SAFETY ASPECTS OF PAEDIATRIC TRIALS Session Chair: Dirk Mentzer, PDCO, Head of Pharmacovigilance Unit, Paul-Ehrlich-Institut, Germany Safety of paediatric patients is the most important aspect when developing new paediatric medicines. Careful investigation of safety and systematic collection of adverse events are in the focus of researchers and regulators. Effects of new medicines on the developing organ system and adequate monitoring of those effects have to be carefully considered. Paediatric Investigational Plans usually require the sponsor to develop and submit a risk management plan including specific aspects related to the paediatric differences. Challenges of Safety Monitoring of Paediatric Patients Carlo Giaquinto, Department of Paediatrics, PENTA Foundation, Italy Long-term Safety Evaluations and Paediatric Pharmacovigilance Stephen Evans, Professor of Pharmacoepidemiology, The London School of Hygiene & Tropical Medicine, UK Integrating Requirements from PIPs into RMPs Janet Hormbrey, Executive Director and EUQPPV, Merck Sharpe and Dohme, Belgium 14:00 Session 0304 PAEDIATRIC DEVELOPMENT - IS A GLOBAL STRATEGY ACHIEVABLE? Session Chair: Paolo Tomasi, Head of Paediatric Medicines, European Medicines Agency, EU Scarce resources available for paediatrics mandate global collaboration to achieve the common goal of "one" global development program. This has been recognised by the FDA and European Medicines Agency and monthly exchanges and discussions have been established. The impact of those interagency interactions on specific paediatric development programmes will be highlighted. Key drivers illustrated by case studies that either facilitate or hinder a global development plan will be identified. This session will discuss how much has been achieved to date, how much is still achievable and which dreams will never come true. Global Paediatric Development - US perspective Ronald Portman, Director, Pediatric Development Program, Bristol-Meyers Squibb, USA Global Paediatric Development - EU perspective and case studies Gloria Garcia Palacios, Associate Director, Corporate Regulatory Affairs, sanofiaventis, France The Impact of New US Legislation on Paediatric Development Dianne Murphy, Director, Office of Pediatric Therapeutics, Office of the Commissioner, FDA, USA 16:00 Session 0305 PAEDIATRIC FORMULATIONS - WILL THEY REACH THE MARKET? Session Chair: Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany Based on ethical principles and the unmet medical need, PDCO regularly requests the development of age-appropriate formulations for most medicinal products. In some cases this leads to additional and sometimes extensive innovative and technically sophisticated pharmaceutical formulation developments. This session will present criteria and expectations from Regulators related to innovative paediatric formulations and the current state of the discussion. Research efforts and experiences from Industry to best possibly respond to the paediatric demand while balancing commercial aspects will be shared. The viewpoint of authorities responsible for cost-effectiveness assessments and the potential impact on access to these new paediatric pharmaceutical forms will be discussed as an additional dimension. PDCO Expectations for Paediatric Formulations Meeting the Medical Need Siri Wang, PDCO, Pharmacist, Tonsberg Hospital Pharmacy, Norway Uncovering the Secrets of Developing Paediatric Asthma Treatment Fadi Eskandar, Principal Scientist, Novartis Pharma AG, Switzerland How do Payors Value Innovative Paediatric Formulations? François Meyer, Director, Health Technology Assessment Division, HAS Haute Autorité de Santé, France Panel Discussion on CHMP Draft Guideline on Pharmaceutical Development of Medicines for Paediatric Use with Diana Van Riet, Coordinator, Regulatory Affairs, RIVM, the Netherlands Wednesday, March 10, 2010 09:00 Session 0306 HARMONISED REGULATORY EXPECTATIONS FOR JUVENILE ANIMAL TESTING? Session Chair: Jacqueline Carleer, PDCO, Safety Assessor, Research and Development, Federal Drug Agency, Belgium Juvenile testing has become a critical planning issue to many early development projects in the EU through concerns at several levels. In this session, guidelines applicable to juvenile non-clinical safety testing as well as practical implications of the regulatory requirements will be addressed. An apparent drift in PDCO decisions on measures from case-by-case testing to
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. general screening and the reasoning for those decisions will be explained. Although there is a "juvenile gap" in standard toxicology programs, it is less clear that juvenile studies in one or two species would be sufficient to reliably screen for unexpected adverse effects on several organs related to humans. A critical analysis of existence and usefulness of juvenile animal studies for all medicines approved for children via the EU centralised procedure (before the Paediatric Regulation 1995-2005) and data requested from those studies for medicines in all approved PIPs (2007-2009), may provide a better understanding of the current evolution of the debate regarding the necessity for those studies and the relevance of findings. Juvenile Non-Clinical Animal Testing in the Development of Paediatric Products: Regulatory requirements and practical implications Marianne Groeneveld, Senior Regulatory Affairs Manager Pharma, TNO Quality of Life, The Netherlands Juvenile Animal Studies: When, why, and what are you going to do with the data? Anders Neil, Principal Consultant, PAREXEL, UK Juvenile Animal Studies in the Development of Paediatric Medicines: Learning with 10 years’ experience of centralised procedure and Paediatric Investigation Plans Dinah Duarte, Regulatory and Scientific Affairs Manager, INFARMED, Portugal Panel with speakers and FDA speaker 11:00 Session 0307 CHALLENGES UNDER THE PAEDIATRIC REGULATION TO OBTAINING THE SPC EXTENSION Session Chair: Geneviève Michaux, of Counsel, Convington & Burling, Belgium Industry is investing a substantial amount of additional research budgets to meet the needs of children and comply with new requirements to conduct paediatric development programs for most of their medicinal products. Although a specific timing challenge for obtaining the deserved rewards exists for already-marketed products, even new products with relatively long patent lives can face challenges considering the staggered safety approach of clinical investigations in various age groups over a longer period of time. In addition, administrative processes may consume relatively long time periods which may be better used for conducting the paediatric programmes. Even after demonstrating full compliance with approved PIPs, inconsistencies in the Paediatric and SPC Regulations and strict interpretation of legal requirements provide additional hurdles for obtaining the rewards under the new system. Explaining sometimes complex regulatory processes relevant for the application of the SPC Regulation at national level is sometimes challenging. Experiences and reasoning of national patent offices for their decisions will be presented and explained. Legal Update after 3 Years Experience with the Paediatric Regulation Chris Foreman, Director, Legal Affairs, Scandinavia Region, Merck Sharpe and Dohme, Belgium European Commission Perspective Commission speaker invited French National Patent Office Perspective Speaker invited 14:00 Session 0308 INITIAL IMPACT OF THE PAEDIATRIC REGULATION AFTER 3 YEARS Session Chair: Thomas Severin, Medical Scientific Expert, Novartis Pharma AG, Switzerland The EU Paediatric Regulation is now in force for more than 3 years. However, its impacts on various stakeholders are still unfolding. A first analysis, impact assessment and conclusions by CROs, industry and regulators will be presented Theme 3 - Theme 4 in this session. It has to be investigated if the stated objective of the Regulation to enhance availability of medicines for the paediatric population has been achieved and whether the requirements are proportionate. Results of the European CRO Federations Surveys on the State of Paediatric Research in Europe Philippa Smit-Marshall, Vice President Medical and Scientific Affairs, PharmaNet, UK Impact on Industry - Resources for paediatric drug development Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services, Germany Impact on Regulators - European Medicines Agency, PDCO and national agency collaboration Agnès Saint Raymond, Head of Human Medicines Special Areas, European Medicines Agency, EU Theme 4 Decision Making: The Key to Efficient and Effective Drug Development, Approval and Access Theme Leaders: Craig Johnson, Principal Regulatory Consultant, Regulatory Information & External Affairs, Eli Lilly, UK Tomas Salmonson, Vice Chairman, CHMP, European Medicines Agency, MPA, Sweden Effective “decision making” is essential for innovative medicinal products to be made available to patients. During the last decade, new stakeholders have emerged who are influencing which product may finally be taken by an individual patient. Company strategies, regulatory approvals, assessments by HTA bodies, international and national treatment recommendations, local drug committees, opinion leaders, treating physicians and, in the end, the (informed) patient may influence choice of treatment. Decision making by all these stakeholders is complex and subjective by nature. Regulatory bodies strive to make their assessment of the benefit/risk of new product valuable tools for other parties, not least of which are the increasingly prominent HTA bodies. However, this aim, while laudable from an efficiency point of view, can only be fully achieved by building trust through adequate and appropriate transparency. Hence, there needs to be a description of the decision making clear enough to allow the reader to agree or disagree with the decision, and to understand the applicability of that decision in the context of their own decision making. Correspondingly, this increasingly complex environment demands that pharmaceutical companies make critical decisions on the most efficient and effective drug development programme to meet both regulatory and HTA needs. The aims of this theme are to examine these elements and consider the ways in which decision-making processes may need to change in response. Ways to approach benefit/risk decisions and increased transparency in this process will be discussed both from an industry and regulatory/health care provider aspect. Various specific aspects of pre-and post-approval decisions will be debated. Monday, March 08, 2010 16:30 Session 0401/1001 PATIENT INFLUENCE ON REGULATORY DECISIONS: HOW MUCH DO THEY AND SHOULD THEY HAVE? (JOINT SESSION WITH THEME 10) Session Chair: Frits Lekkerkerker, Member NDA Advisory Board, NDA Regulatory Science Ltd., UK Patient organisations are increasingly involved in the activities of the European Medicines Agency, but how much influence do they (and should they) have? This session will consider the views of various stakeholders on the involvement of patients in the work of the European Medicines Agency and its scientific 23
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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