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DIA Europe’s Copenhagen conference creates a unique forum for innovation

26 to 28 March 2012 at the Bella Center, Copenhagen

Dr Brigitte Franke-Bray

DIA Euro Meeting highlights :

• More than 110 sessions attracting more than 3,000 professionals involved in the development of medicines from more than 50 countries
• Speakers from the European Medicines Agency, the European Commission, the FDA and other regulatory agencies from European countries and other regions of the world
• More than 200 exhibitors on one of the largest exhibition floors in Europe
• Unparalleled multi-disciplinary networking opportunities
• Student and professional poster sessions
• Active involvement of patient organisations
• Pre-conference tutorials and training sessions led by an expert faculty
• The annual DIA awards ceremony will take place during the opening plenary
• Hot topic sessions

Ethical practices in the pharmaceutical sector - panel discussion panellists

• Mr David Brennan, CEO, AstraZeneca
• Ms N icola Bedlington, Director, European Patients’ Forum
• Professor H azel Biggs, Professor of Health Care Law and Bioethics, Co-Director HEAL (Health Ethics and Law), Academic Lead Pathways2Law, Editor-in-Chief Medical Law
  Review, School of Law, University of Southampton, UK
• Professor Liselotte H øjgaard, Chair EMRC, Department of Clinical Physiology, Nuclear Medicine & PET, Rigshospitalet, University of Copenhagen, Denmark
• Professor Guido Rasi, Executive Director, European Medicines Agency, EU (to be confirmed)
• Mr Lars Rebien Sørensen, President and CEO, Novo Nordisk

Commenting on the topical nature of the themes at the 2012 EuroMeeting, Dr Brigitte Franke-Bray said: "The whole meeting has been designed to be both thought provoking and informative. We recognise that the global downturn is just one of a host of external factors posing all manner of challenges for the industry. But we cannot use that as an excuse not to debate the pressing issues of our time. That is why we are starting off the meeting with a special plenary session panel discussion on ethical practices in the pharmaceutical sector."

Following the plenary session, the EuroMeeting’s carefully chosen themes and interactive sessions aim to provide the perfect forum for examining many of the major issues facing drug developers.
"Particular attention will be given to how ‘unmet medical needs’ are being addressed and to best practices of managing Health Technology Assessments (HTA). Special focus will be given to contemporary issues in data transparency such as the publication of clinical trial data," emphasised Dr Franke-Bray.

To suit the tastes of the broad-based audience expected at the EuroMeeting, its themes include the professional disciplines of regulatory affairs, safety and efficacy for human medicines, diagnostics and devices. It is expected that much innovation will be fostered by interaction between disciplines and jointly between the stakeholders of healthcare innovation such as industry professionals, academia, regulatory competent authorities, patient representatives and the general public.

Copenhagen’s life-science heritage makes it the ideal setting for the DIA’s 2012 EuroMeeting. As well as a packed programme there are numerous opportunities for networking with like-minded individuals and for enjoying all that Copenhagen has to offer.

Some of the meeting's themes
Innovation and Unmet Medical Needs will explore trends in pharmaceutical innovation such as personalised medicine, orphan drugs, medicines for geriatric or ageing populations and priority medicines.

The Regulatory Affairs theme will focus on current regulatory "hot topics". These include new EU legislation, guidelines as well as developments within the European regulatory agency network influencing the way medicinal products are being developed and brought on to the European market that are either in the pipeline, recently approved or in the implementation phase.

Led by Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board, The Netherlands and Margaret Walters, Director, EU PV and DQPPV, Merck Sharp & Dohme Ltd, UK, Benefit/ Risk Management and Lifecycle Approach will provide extensive information on these aspects of safety and will also focus on those areas likely to be impacted by the forthcoming pharmacovigilance legislation implementation.

Luca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency and Ingela Wiklund, Senior Research Leader, Centre for Health Outcomes Research, United BioSource Corporation, UK, lead Health Technology Assessment (HTA) and Efficacy and Clinical Evidence. The aim of this theme is to illustrate various points of view from the general, for example the European Network for HTA (EUnetHTA), to specific landscapes, such as local bodies, regions and hospitals.

Maren Von Fritschen, Director, Regulatory Affairs, PharmaLex.

Germany and Emmanuelle Voisin, Chief Executive Officer, Voisin Consulting, France are the theme leaders for Special Medicinal Products. This theme will present creative paths followed during drug development and marketing authorisation of generics, biosimilars, 'old' substances in new technologies, ATMPs (Advanced Therapy Medicinal Products) and borderline products summarised as "pecial medicinal products". The focus will be on critical issues during clinical and technological development together with areas of improvement during the marketing authorisation process. Case studies and pitfalls will be presented, enabling shared experience and learning from each other.

The Translational Medicine Enabling Successful Clinical Development theme is headed by Lars Arendt-Nielsen, Director, Centre for Sensory-Motor Interaction, Department for Health Sciences and Technology, Aalborg University, Denmark and Paul de Koning, Vice-President, Head Global, Clinical Pharmacology and Exploratory Development, Astellas Pharma B. V., The Netherlands. The way to successful Translational Medicine through a clear understanding of the unmet medical needs of patients will be explored, with emphasis on translating this understanding into research targets in both animal and human models. The theme will demonstrate how successful clinical development strategies incorporate these models, as well as biomarkers, in assessing whether a compound meets its target product profile and whether it can be differentiated from competitors and ultimately make a difference to patients.

In the packed 2012 EuroMeeting programme there also are no fewer than 21 tutorials covering a diverse range of subjects from the analysis of safety data from clinical trials to the development of paediatric medicinal products from a regulatory standpoint.

About the DIA

• The DIA is a neutral, global association of approximately 18,000 members who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products.
• The DIA is committed to the broad dissemination of information on the development of new medicines or generics, biosimilars, medical devices and combination products with continuously improved professional practice as the goal.
• The DIA is an independent non-profit organisation. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications at a reasonable, competitive cost.
• DIA’s headquarters are in H orsham, PA, USA, with the European office in Basel, Switzerland, and further regional offices in North America, Japan, India and China.
• For more information on DIA events and training courses visit www.diahome.org or call DIA Europe +41 61 225 51 51.