preliminary programme2 by Nordix Travel

24th Annual

EuroMeeting

C o p e n h a gen 2012 26-28 March 2012 Bella Center | Copenhagen, Denmark

Preliminary Programme

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EUROMEETING 2012 THEME LEADERS Lars Arendt-Nielsen Director, Centre for Sensory-Motor Interaction, Department for Health Sciences and Technology, Aalborg University, Denmark

Gautam Maitra Head of Regulatory Affairs and External Affairs, AC Immune, Switzerland

Sabine Straus Head of Pharmacovigilance, Medicines Evaluation Board (MEB), The Netherlands

Nicola Bedlington Director, European Patients' Forum, EU

Thomas Metcalfe Head, Science and Technology Incubator, F. Hoffmann-La Roche, Switzerland

Hans van Bruggen Director, eCTD Consultancy B.V., The Netherlands

Gesine Bejeuhr Senior Manager Regulatory Affairs/ Quality, vfa Research-Based Pharm Companies, Germany

Estelle Michael Senior Manager, Regulatory Policy Worldwide Vaccine Registration, GlaxoSmithKline Biologicals, Belgium

Emmanuelle Voisin Chief Executive Officer, Voisin Consulting, France

Thomas Bols Vice President Corporate Health Policy & Market Access, Merck Serono S.A., Switzerland

Trine Moulvad Vice President, Novo Nordisk A/S, Denmark

Maren Von Fritschen Director Regulatory Affairs, PharmaLex, Germany

Emer Cooke International Liaison Officer, European Medicines Agency, EU

Henrik Kim Nielsen Corporate Vice President, RA Haemostasis, Novo Nordisk A/S, Denmark

Margaret Walters Director, EU PV and DQPPV, Merck Sharp & Dohme Ltd, UK

Paul de Koning Vice President, Head Global, Clinical Pharmacology and Exploratory Development, Astellas Pharma B.V., The Netherlands

Kristin Raudsepp Director General, State Agency of Medicines, Estonia

Barbro Westerholm Professor Emerita, Member of Swedish Parliament, AGE - Older People's Platform, Belgium

Luca De Nigro Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy

Siegfried Schmitt Principal Consultant, PAREXEL, UK

Ingela Wiklund Senior Research Leader, Centre for Health Outcomes Research, United BioSource Corporation, UK

Shayesteh Fürst-Ladani Director, SFL Regulatory Affairs and Scientific Communication Ltd., Switzerland

Jørgen Seldrup Senior Strategic Biostatistics Director, Quintiles, France

Geoffrey Williams Associate Director, Regulatory Operations, Daiichi Sankyo Development Ltd., UK

David Haerry EATG Representative, European AIDS Treatment Group, Belgium

Eva Skovlund Scientific Director, Norwegian Medicines Agency, Norway

not available

EuroMeeting Quick Facts • Neutral, global forum featuring over 120 sessions attracting more than 3,000 professionals involved in the development of medicines from more than 50 countries

• Unparalleled multi-disciplinary networking opportunities

• Speakers from the European Medicines Agency, the European Commission, the FDA and other regulatory agencies from European countries and other regions of the world

• Active involvement of patient organisations

• More than 200 exhibitors on one of the largest exhibition floors in Europe

• Hot topic sessions

• Student and professional poster sessions

• Pre-conference tutorials led by expert faculty

EUROMEETING 2012 CO-CHAIRS’ MESSAGE

Welcome from the EuroMeeting 2012 Co-Chairs Dear Colleague, We are looking forward to welcoming you to Copenhagen for the 24th DIA Annual EuroMeeting taking place at the Bella Center from 26-28 March 2012. Copenhagen is embedded in the Scandinavian culture of high standards of living and Scandinavia is characterised by a healthcare system with unique features. In addition, our city is the metropolitan area of one of the leading clusters of biotech, pharma and medtech innovation, and as such has much to showcase. 2012 is also the year when Denmark takes the baton of the Presidency of the Council of the European Union, leveraging opportunities for leadership to bring forward innovation, both in the life science and in the healthcare sectors. Stakeholders and professionals of healthcare and life sciences innovation will gather from all over the World for the EuroMeeting 2012. You will experience a neutral, global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide. It is our vision that the EuroMeeting 2012 offers you a multi-disciplinary, relevant and unforgettable learning experience and expands your personal and professional network. The themes for the EuroMeeting 2012 include the professional disciplines of regulatory affairs, safety and efficacy for human medicines, diagnostics and devices. 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. We envisage that the EuroMeeting 2012 will bring stakeholders closer together facilitating and enabling better decision making in the processes of bringing new innovative products to the market in a fast, ethical, outcome-focused and financially sound manner. Attention will be given to how “unmet medical needs” are being adressed and to best practices of managing Health Technology Assessment (HTA). Special focus will be given to contemporary issues in data transparency, e.g. publication of clinical trial data. We furthermore envisage that the EuroMeeting 2012 will transcend borders and boost international relations by drawing attention to contemporary issues outside Europe such as in the USA, Brazil, China, Japan and India; and focusing on contemporary issues at the interface between those countries and Europe. Thus, 2012 in Copenhagen will be an exciting opportunity to bring innovation to healthcare and life science and we warmly welcome your participation. Jytte Lyngvig and Per Spindler

Jytte Lyngvig Dr Jytte Lyngvig is Chief Executive Officer of the Danish Medicines Agency, a position she has held since 2000. She qualified as a chemical engineer at the Technical University of Denmark in 1976 and has a Ph.D. in Socio-Economic Planning, Institute of Mathematical Statistics and Operations Research, Technical University of Denmark and Bilingual Commercial Correspondent (Danish/French) in 2000. She is a member of the EMA Management Board. She was a member of the Heads of Medicines Agencies Management Group from 2004 to 2009 and Chair of the group from 2005 to 2009.

Per Spindler Dr Per Spindler is Director of Biopeople, University of Copenhagen. Dr Spindler qualified as Doctor in Veterinary Medicine from the University of Copenhagen in 1991 and has in addition a Master’s in Applied Toxicology from the University of Surrey, UK, and an Executive Master of Business Administration from the Scandinavian International Management Institute in Copenhagen. He has been Board Director at the Drug Information Association since 2007.

Programme Advisors Daniel Brasseur, Member, Federal Agency for Medicines and Health Products, PDCO Chairman, Belgium Nikos Dedes, Representative, European AIDS Treatment Group (EATG), Greece Fritz Erni, Consultant, Switzerland Georges France, Vice President Quality Strategy, Global Quality Operation, Pfizer, UK Brenton James, Consultant in Strategic Regulatory Affairs in the European Union, UK Ding Jianhua, Deputy Director, Division of Pharmacy and Department of Drug Registration, State Food and Drug Administration (SFDA), China Maria Mavris, Drug Development Programme Manager, EURORDIS, France Melek Önol, DRA & Quality Assurance Manager, Boehringer Ingelheim Ilaç Tic A.S., Turkey Jean-Louis Robert, Head, Department of Medicines Control Laboratory, National Health Laboratory, Luxembourg

EUROMEETING 2012 THEMES AND THEME LEADERS Theme 1 | Innovation and Unmet Medical Needs Thomas Bols, Vice President Corporate Health Policy & Market Access, Merck Serono S.A., Switzerland Nicola Bedlington, Director, European Patients' Forum, EU This theme will explore trends in pharmaceutical innovation such as personalised medicine, orphan drugs, medicines for geriatric or ageing populations and priority medicines. How this innovation is applied by the R&D-based industry to create value and benefit for patients, and solutions for unmet medical needs in diseases including cancer, neurological disorders and other serious or chronic conditions will be the focus of the sessions comprising this theme. The sessions will feature renowned speakers from different stakeholder groups, namely patients, industry, regulators and policy makers, who will describe the opportunities and challenges related to these trends and the key issues around them. Among the questions that will be discussed are how to stimulate R&D and maintain incentives for it to continue; how to demonstrate the connection between patient drug usage and improved treatment outcomes; how adherence data is considered in Health Technology Assessments (HTA); and what the patients' perspectives are on all of these topics. The theme will also include extremely interesting and lively debates on issues that are at the forefront of pharmaceutical policy today. Proposed topics: • Antibiotics resistance • IMI • New pharmaceutical package • Paediatric medicines • Gene therapy and stem cells • Information for patients • European Commission impact assessment of the Clinical Trial Directive • Investment and funding in product development for specific patient populations • Clinical studies • Biologicals • Biomarkers • Investigators

Theme 2 | Regulatory Affairs Trine Moulvad, Vice President, Novo Nordisk A/S, Denmark Kristin Raudsepp, Director General, State Agency of Medicines, Estonia The Regulatory Theme will focus on the status of current regulatory “hot topics” where new EU legislation and guidelines, as well as developments within the European regulatory agency network, influence the way medicinal products are being developed and brought to the European market. Proposed sessions: • Latest News from the European Medicines Agency • Benefit-Risk Assessment • Clinical Trials • EU Regulatory Network • Information for Patients • Counterfeit/Falsified Medicines • Regulation of Drug/Device Combinations • New Pharmacovigilance Legislation

Theme 3 | Safety – Risk Management and Lifecycle Approach Sabine Straus, Head of Pharmacovigilance, Medicines Evaluation Board (MEB), the Netherlands Margaret Walters, Director, EU PV and DQPPV, Merck Sharp & Dohme Ltd, UK The benefit /risk monitoring of a medicinal product relies on a complex system of collection, processing, reporting and analysis of data and information throughout the whole lifecycle. The new pharmacovigilance legislation, Regulation (EU) No 1235/2010 and Directive 2010/84/EU on pharmacovigilance will come into force in mid-2012. This new pharmacovigilance legislation will contribute to the promotion and protection of public health through continuous monitoring of the benefit/risk balance, by optimising the safe and effective use of medicines, and through this will move towards reducing the burden of adverse drug reactions. The new legislation reinforces the key product surveillance and public health principle of monitoring medicinal products’ benefit/risk profile throughout the product lifecycle. This new public health legislation is far reaching in scope and depth, and goes far beyond any narrow concept of pharmacovigilance. It will strengthen safety monitoring, rationalise reporting and increase the use of studies including pharmacoepidemiology. It makes clear roles and responsibilities, sets out decision making, increases patient participation, reinforces transparency and strengthens the action that can be taken to protect and promote public health. Implementation of this new pharmacovigilance legislation and related guidance in the EU offers a unique opportunity to define principles and operational standards. Achieving effective and timely implementation will require significant and important change together with new process implementation by all stakeholders. This theme will provide extensive information on safety risk management and lifecycle approaches, combined with an exploration of many of those areas likely to be impacted by the forthcoming pharmacovigilance legislation implementation. Proposed sessions: • PASS and PSURs under the New Legislation • Risk Communication and Transparency • Lifecycle Management Risk Management Plans Under the New Legislation • Collaboration in Pharmacovigilance • Risk Minimisation (CIOMS IX) • Pharmacovigilance Reports from Social Media and Patient Support Programmes • Global Risk Management Planning

EUROMEETING 2012 THEMES AND THEME LEADERS

Theme 4 | Health Technology Assessment (HTA) and Efficacy and Clinical Evidence

Theme 6 | Translational Medicine Enabling Successful Clinical Development

Luca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy Ingela Wiklund, Senior Research Leader, Centre for Health Outcomes Research, United BioSource Corporation, UK

Lars Arendt-Nielsen, Director, Centre for Sensory-Motor Interaction, Department for Health Sciences and Technology, Aalborg University, Denmark Paul de Koning, Vice President, Head Global, Clinical Pharmacology and Exploratory Development, Astellas Pharma B.V., the Netherlands

Health policy analyses are becoming increasingly important in a world where, nowadays, taking unweighed decisions is no longer sustainable in terms of appropriateness and costs. The HTA processes profess themselves to be good partners, although not the only ones, of all the stakeholders involved: healthcare professionals, decision makers, patients, regulators, payers and industry. Nevertheless, they need to be widely shared as common viewpoints and definitions. The aim of this theme is to illustrate the several points of view from the general, for example the European Network for HTA (EUnetHTA), to the specific landscapes, such as local bodies, regions and hospitals. And to take into account the multiple interdisciplinary aspects related to health economics and access to care. A special emphasis will be placed on the HTAs making process in a context of effectiveness data deficiency, only partially filled up by collecting data from the real world or from comparative effectiveness research. Proposed sessions: • Do We Really Need Central Resources for HTA? • Making or Buying HTA • Using the Real World Data Could Improve the Power of HTAs • Every Patient is Different and Every Treatment is Also Different • Agency-Based Assessment of Therapeutic Value and Therapeutic Added Value – update • Balancing the Needs of Decision Makers and Companies: The never-ending story • Do HTA Processes Really Contribute in Shaping Reimbursement Policies?

Theme 5 | Special Medicinal Products Maren Von Fritschen, Director Regulatory Affairs, PharmaLex, Germany Emmanuelle Voisin, Chief Executive Officer, Voisin Consulting, France The pressure on pharmaceutical companies bringing high quality medicinal products that benefit patients to the market is enormous. In a globalising world with growing regulatory requirements, market barriers and competition intelligent strategic considerations are needed. There is no common standardised straight line as the crow flies for bringing a product to the market. This theme will present creative, innovative and inconvenient paths for “special medicinal products” including generics, biosimilars, ATMPs, tissue engineering, as well as new technologies for “old” substances. Pitfalls out of the ordinary will be shared, learning from each other and sharing experiences. Proposed sessions: • Global Development Program Bio(super)similars – Next generation • Biosimilars – The fine art of submission: case studies • Biosimilars – Next generation, monoclonal antibodies • Generics – Perspectives (incl. BE, Biowaiver) • Generics vs. New Technologies for “Old” Substances • ATMP – Mission Possible • Borderline Products - Classification strategies

Translational medicine can only be successful if we have a clear understanding of the unmet medical needs of patients. This understanding needs to be translated into research targets, animal and human models. Successful clinical development strategies incorporate these models and biomarkers to assess whether a compound meets its target product profile, can be differentiated from competitors and ultimately make a difference to patients. The road to success is paved with uncertainties around “translatability”. Proposed sessions: • Should Marketing Be Interested in Translational Medicine? • Regulatory “Approval” of Biomarkers and the Added Value in Early Drug Development • From Biomarkers to Diagnostics and Prognostics • Back-Translation: What can development teach discovery • Mechanism-Based Biomarkers in Early Drug Development: • Translational Research in Pain, Inflammation, Arthritis, Dermatology, Diabetes and Cancer

Theme 7 | Statistics in Drug Development Jørgen Seldrup, Senior Strategic Biostatistics Director, Quintiles, France Eva Skovlund, Scientific Director, Norwegian Medicines Agency, Norway Statistics and statistical science play a key role in drug development. In this theme we will explore the interface between statistics, clinical medicine and regulatory requirements. In addition to providing a forum for statisticians to exchange knowledge and experience and to continue to address statistical and regulatory hot topics, we also intend to create an opportunity for an open and useful discussion with other disciplines involved in the drug development arena. Only by true teamwork will we succeed in timely development of new drugs for the benefit of patients. Proposed sessions: • Portfolio Management • Safety – Signal Detection • Biomarkers • Modelling and Simulation • Statistical Issues in Oncology • Responder Analysis • Regulatory Issues

EUROMEETING 2012 THEMES AND THEME LEADERS Theme 8 | CMC, Inspections and Quality Siegfried Schmitt, Principal Consultant, PAREXEL, UK Gautam Maitra, Head of Regulatory Affairs and External Affairs, AC Immune, Switzerland Virtualisation, globalisation and a fiercely competitive business climate impact on where, how and by whom evidence is generated for compilation in the CMC section of the dossiers. Regulatory implications affecting any part of the product lifecycle, from laboratory to commercial production, must be addressed, finding the right balance between quality/compliance and speed to market. Practical solutions, expertise from industry and regulators and latest developments - especially with small and medium sized companies in mind - will be presented. Proposed sessions: • Regulatory Compliance • Advanced Therapy Products • Modern Delivery Systems • The GMP/GLP Interphase • Clinical Trial Site Inspections and Material Logistics • SOPs Needed for Start-Up Companies • Supply Chain/Anti-Counterfeiting/Globalisation

Theme 9 | Impact of Device, Drug and Diagnostic Combinations on Future Healthcare Evolution Shayesteh Fürst-Ladani, Director, SFL Regulatory Affairs and Scientific Communication Ltd., Switzerland Thomas Metcalfe, Head, Science and Technology Incubator, F. Hoffmann-La Roche, Switzerland In this theme we will give an overview on the status quo of device, diagnostic and drug combinations regulation in US, Europe and the Rest of the World (RoW) and describe how the regulatory environment is evolving. The impact on the industry due to the recast of the European Medical Device Directives and the revision of the In Vitro Diagnostics Directive (IVDD) will be discussed and changes in FDA regulation and the work of the Global Harmonisation Task Force (GHTF) will be addressed. Practical guidance on developing combination products will be given from quality, non-clinical, clinical and vigilance perspectives. In addition, the development and approval of e-Health/ telehealth solutions designed to improve patient adherence to their medication will be addressed. Companion diagnostics are at the heart of the personalised medicine and are becoming more and more important in drug development. The case studies will provide advice on how to develop companion diagnostics in compliance with the regulatory requirements in the EU and US. Clinical laboratory accreditation processes and quality assessment services and their role in ensuring the quality of clinical test provision, particularly related to companion diagnostics will also be addressed. The challenges presented by rapidly evolving novel technologies and multi-parameter tests, including the clinical application of technologies such as expression profiling and sequencing and the value of diagnostic testing will be discussed. Proposed sessions: • Recast of Medical Device Directives and In Vitro Diagnostics Directive Revision • Device and in vitro Diagnostic Regulations in the EU, US and GHTF • Regulation and Development of Combination Products

• Regulatory Requirements for Development of Companion Diagnostics • Value of Diagnostic Testing and HTA • e-Health • Clinical Laboratory Accreditation Processes

Theme 10 The "e" World, Knowledge Management and Electonic Data Management Geoffrey Williams, Associate Director, Regulatory Operations, Daiichi Sankyo Development Ltd, UK Hans van Bruggen, Director, eCTD Consultancy B.V., the Netherlands The growing complexity of pharmaceutical development is leading to a huge increase in the amount of data generated to support the pre- and post-licensing evaluation of quality, safety and efficacy of drugs. In addition, initiatives such as the creation of electronic healthcare records for individual citizens in EU countries are greatly increasing the amount of potential data available for use in clinical research. Nearly all of this data is generated, analysed and transmitted in an electronic format. In this environment two key areas stand out if the most is to be made of this data. Firstly, a common understanding of terms used across the entire network is necessary to ensure that the maximum useful knowledge can be extracted from the data with the minimum need to convert and re-analyse the information. Secondly, the creation of tools that allow users to combine, analyse and interpret data from many sources. Underlying these areas should be a clear strategy that identifies the key needs of industry, regulators and patients and directs the future developments for knowledge management to the eventual benefit of patients. This theme will explore these challenges across the clinical development and regulatory work areas. It will aim to explore the topics of current interest within the industry and with regulators and the strategies being developed and implemented to maximise the use of the generated data. The development of standard terminology in clinical research for health records, the common and mutually agreed identification of medicinal products to support licensing and pharmacovigilance and the standards for the transmission of regulatory submissions will all be examined in more detail. In addition, more practical case studies demonstrating how companies and regulators are using these data sources will also be highlighted. Proposed sessions: • Identification and Management of Medicinal Product Information • Electronic Submissions (eCTD, NeeS, RPS) • Data Standards (CDISC) • Trial Registries • Electronic Health Records in Clinical Research and Pharmacovigilance • ePRO and Other Technologies • The Role of Technology in Supporting Transparency Initiatives

Theme 11 | Special Populations Gesine Bejeuhr, Senior Manager Regulatory Affairs/Quality, vfa ResearchBased Pharm Companies, Germany Barbro Westerholm, Professor Emerita, Member of Swedish Parliament, AGE Older People`s Platform, Belgium Special populations such as children and the elderly require particular attention during drug development. As for the younger population, the requirements introduced by the Paediatric Regulation in 2007 slowly started to deliver more, better quality data for medicines used in children. Constant dialogue between all stakeholders

EUROMEETING 2012 THEMES AND THEME LEADERS led to new methodologies such as modelling and simulation to try to avoid unnecessary clinical trials. The increased academic collaboration under the umbrella of the EnprEMA and growing experience both of the PDCO and industry has started to make the process more efficient. The focus is now on practical questions during paediatric trials more than on purely regulatory aspects. National competent authorities, ethics committees and patients/ parents need to be included more in the discussions. The changing demography with a higher percentage of elderly and very elderly people leads to reconsideration in other aspects. Multiple diseases and concomitant medication are just two topics to be addressed in drug development. There are also other special needs such as easy handling and colouring agents to avoid medication errors and inappropriate formulations. Specific difficulties of performing clinical trials on the very elderly and practical experience will be shared including ethical issues, in particular when patients are no longer fully capable of giving their consent. The European Commission launched an initiative on “Healthy Ageing”. Prevention of diseases and early detection e.g. of Alzheimer's Disease, will play an important role in future. These initiatives will be presented and analysed. Proposed sessions: • Paediatric Regulation – 5 years later • Challenges in Paediatric Clinical Trials • Collaboration in Paediatric Trials between Companies and EnprEMA • Very Small Patient Groups • Healthy Ageing • Clinical Trials in Elderly and Very Elderly • Prevention and Early Detection of Neurodegenerative Processes

Theme 13 | Biologicals and Vaccines Estelle Michael, Senior Manager, Regulatory Policy Worldwide Vaccine Registration, GlaxoSmithKline Biologicals, Belgium David Haerry, EATG Representative, European AIDS Treatment Group, Belgium In this theme we plan to address opportunities and challenges in relation to the development of biologicals and vaccines. In the first three sessions, we will focus on the current regulatory environment and the impact it is having on both marketed products and those under development. In the following two sessions, we will start to look to the near future to see what is on the horizon; and in the last part, look beyond the horizon and try to decipher what innovations might bring us the biologicals and vaccines of the future. Proposed sessions: • Opportunities for Further Harmonisation of Biological and Vaccine Regulations • Developing New Biologicals – The challenges • Enabling “Truly Global” Market Access • Advanced Therapies – Current and planned initiatives • Novel Delivery Systems for Vaccines/Biologicals • New Tools, New Thinking • What are the Regulatory Challenges facing Future Innovations and CuttingEdge Technology?

Confirmed Session Chairs • Lars Arendt-Nielsen, Director, Centre for Sensory-Motor Interaction,

Theme 12 | Globalisation and Its Challenges Henrik Kim Nielsen, Corporate Vice President, RA Haemostasis, Novo Nordisk A/S, Denmark Emer Cooke, International Liaison Officer, European Medicines Agency, EU Increasing globalisation poses many challenges to drug development, regulators and the pharmaceutical industry. Drug development and the supply of medicinal products have gone from being local or regional activities to becoming global. The supply chains have become more fragmented and sourcing in developing countries has increased tremendously; and at the same time growth markets such as China, Brazil, India, Russia and Turkey have become the focus of many pharmaceutical firms. Global clinical trials have become state-of- the-art, and ethnicity issues and a need for local patient participation is receiving heightened attention. This theme will explore how regulators and industry are addressing globalisation in 2012. Proposed sessions: • Clinical Trials Including How to Get a Global Trial Started; Ethnicity Issues • The Global Supply Chain - Challenges from industry and regulator perspective • Fora for Global Regulatory Collaboration Including the WHO • Achieving Global Approvals • Managing Global Project Teams - Cultural challenges • China News • EU, USA and Japan (I) – Status reports on the international collaboration • EU, USA and Japan (II) – Reports from the regulators on exchange assignments

Department for Health Sciences and Technology, Aalborg University, Denmark • Iman Barilero, Vice President, Regulatory Development Strategy and Policy, H. Lundbeck A/S, Denmark • Karl Broich, Head of Section, Neurology/ Psychiatry, BfArM, Germany • Andre Broekmans, Vice President Regulatory Affairs & Regulatory Policy, Merck, Shape and Dohme (Europe), the Netherlands, • Emer Cooke, International Liaison Officer, European Medicines Agency, EU • Marie Dray, President, International Regulatory Affairs Group LLC, USA • Alar Irs, Deputy Director General, State Agency of Medicines, CHMP member, Estonia • Brenton James, Consultant in Strategic Regulatory Affairs in the European Union, UK • Aginus A.W. Kalis, Executive Director, Medicines Evaluation Board, the Netherlands, Chair of the HMA Management Group • Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), EU • John Kerridge, Quality Leader, EMACIS Business Dept and EU External Relations (GMP), Eli Lilly, UK • Lawrence E. Liberti, Executive Director, Centre for Innovation in Regulatory Science (CIRSI), USA • Ragnar Lofstedt, Director, the King's Centre for Risk Management, The International Policy Institute, King's College London, UK • Gautam Maitra, Head of Regulatory Affairs and External Affairs, AC Immune, Switzerland • Henrik Kim Nielsen, Corporate Vice President, RA Haemostasis, Novo Nordisk A/S, Denmark • Solange Rohou, Director, Regulatory Affairs, AstraZeneca, UK

STUDENT AND PROFESSIONAL POSTERS

CALL FOR STUDENT POSTER ABTRACTS

Full-time undergraduate university students are invited to submit abstracts for the 24th Annual EuroMeeting. A total of €1,800 in prize money will be awarded to student winners based on the following criteria: • Bona fide research project • Specific objectives and hypothesis • Clear methods • Analysis of actual data and results • Conclusion A maximum of 20 abstracts will be selected for the student poster presentation. ELIGIBILITY Full-time undergraduate students at the time of the presentation. One author only must attend the EuroMeeting. Past DIA EuroMeeting or Annual US meeting Student Poster Presenters are not eligible BENEFITS • One fully supported registration for the EuroMeeting to include: return flight to Copenhagen, three nights hotel accommodation and complimentary registration for the EuroMeeting • Complimentary one-year membership to DIA • Accepted abstracts will be printed in an early 2012 issue of the Drug Information Journal SUBMISSION REQUIREMENTS Please read the following instructions carefully. Incorrectly submitted abstracts will not be considered. 1. All poster abstracts must be received by Thursday, 1 December 2011. 2. A student may submit only one abstract. 3. Abstracts may not refer to specific brand names. 4. Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions. 5. Submissions must include complete contact information. 6. Abstracts will be reviewed and authors notified of results by Thursday, 15 December 2011. HOW TO SUBMIT AN ABSTRACT Visit www.diaeurope.org/euromeeting2012 and click on “Posters and Fellowships” on the horizontal bar. The following information will be required: • Keywords – one or more keywords associated with your abstract (limited to 100 characters including spaces) • Objective – a one-sentence statement • Method (limited to 300 characters including spaces) • Results (limited to 300 characters including spaces) • Conclusion (limited to 300 characters including spaces)

CALL FOR PROFESSIONAL POSTER ABSTRACTS

A maximum of 40 abstracts from full-time professionals will be selected for the professional poster session at the 24th Annual EuroMeeting and displayed at the Bella Center during the conference. Selected professional poster presenters will be required to pay the applicable meeting registration fee and will be responsible for all other meeting expenses. SUBMISSION REQUIREMENTS Please read the following instructions carefully. Incorrectly submitted abstracts will not be considered 1. All poster abstracts must be received by Friday, 13 January 2012. 2. Abstracts may not refer to specific brand names. 3. Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions. 4. Submissions must include complete contact information. 5. Abstracts will be reviewed and authors notified of results by Friday, 20 January 2012. Prizes will be awarded to professional poster winners at the EuroMeeting 2012 Copenhagen

PROFESSIONAL POSTERS | FELLOWSHIPS | HOTELS

HOW TO SUBMIT AN ABSTRACT Visit www.diaeurope.org/euromeeting2012 and click on “Posters and Fellowships” on the horizontal bar. The following information will be required: • Keywords – one or more keywords associated with your abstract (limited to 100 characters including spaces) • Objective – a one-sentence statement • Method (limited to 300 characters including spaces) • Results (limited to 300 characters including spaces) • Conclusion (limited to 300 characters including spaces)

EUROMEETING FELLOWSHIP PROGRAMMES PATIENT FELLOWSHIP – Applications accepted from 12 September 2011 Application Deadline: 25 November 2011 The DIA Patient Fellowship, now in its seventh year, is a programme to promote the participation of representatives of patient organisations at the EuroMeeting. DIA fully supports 22 patient representatives covering their complete travel and accommodation costs plus complimentary admission to the EuroMeeting, and is offering 25 additional patient representatives complimentary registration for the Meeting.

STUDENT FELLOWSHIP - Applications accepted from 12 September 2011 Application Deadline: 27 January 2012 DIA Europe promotes the participation of students in the annual EuroMeeting by offering up to 15 complimentary registrations for full-time graduate or postgraduate students.

YOUNG PROFESSIONAL FELLOWSHIP - Applications accepted from 12 September 2011 Application Deadline: 27 January 2012 DIA Europe promotes the participation of young professionals in the annual EuroMeeting by offering up to 15 complimentary registrations for professionals under the age of 30.

SPECIAL HOTEL RATES FOR YOUR EUROMEETING 2012 ACCOMMODATION IN COPENHAGEN DIA Europe has negotiated special conference hotel rates which include breakfast, service and all taxes. To reserve your room, visit www.diaeurope.org/ euromeeting2012 and click on Hotel/Travel Information. You will be able to find further details such as pricing and proximity to the Bella Center where the EuroMeeting will take place.

Please be advised that DIA has only one contracted and exclusive hotel agent for the EuroMeeting 2012: K.I.T. Group. DIA works with one agent to ensure that: • Your hotel reservations are officially part of the EuroMeeting. • The hotels rates have been individually negotiated for the EuroMeeting and are exclusive to EuroMeeting participants. • Your hotel reservations, privacy and personal data are completely secure.

EuroMeeting 2012 Conference Hotels in Copenhagen Bella Sky Comwell – EuroMeeting Headquarters Hotel Crown Plaza Copenhagen Towers Marriott Copenhagen Radisson Blu Falconer

Radisson Blu Royal Radisson Blu Scandinavia Scandic Copenhagen Scandic Webers

ABOUT THE EUROMEETING | EXHIBITION

REACH YOUR IDEAL TARGET AUDIENCE IN COPENHAGEN! Showcase your company’s product or service to over 3,000 drug development professionals at the EuroMeeting 2012 in Copenhagen. Join over 200 exhibitors to interact with professionals from over 50 countries in the pharmaceutical, devices, government, academia, healthcare delivery and related industries and with representatives from patient organisations. Booth space is sold on a first come first served basis. The fee is €4,650 for a 3x3m space. Each booth space includes prefitted shell-scheme, carpet, standard electrical supply, one table, three chairs, coffee breaks, lunches and receptions, one full meeting registration (which allows access to all scientific sessions) and up to three exhibit booth personnel registrations.

Sign up now to be sure of the space of your choice! For more information on exhibition space and facilities, please contact Natacha Scholl at the DIA on +41 61 225 51 59 or email: natacha.scholl@diaeurope.org

HAVE YOU SEEN THE EUROMEETING 2012 WEBSITE? Simply go to www.diahome.org and click on the EuroMeeting icon.

DIA HAS CREATED A GROUP ON THE SOCIAL NETWORKING SITE, LINKEDIN: Visit www.linkedin.com > search groups > DIA 24th Annual EuroMeeting

• Connect with speakers, attendees and exhibitors prior to the conference • Share ideas and experiences with colleagues in your field • Arrange meetings and network online with fellow delegates You will be able to:

• Speakers will lead discussions on topics that will be covered at the EuroMeeting

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• Get information on being an exhibitor • Find out more about student and young professional activities • Take advantage of specially-negotiated hotel rates in Copenhagen • Learn more about the city of Copenhagen

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NETWORKING OPPORTUNITIES | GLOSSARY

NETWORKING EVENTS - ALL INCLUDED IN YOUR REGISTRATION RATE! Welcome to Copenhagen Reception on Monday, 26 March 2012 Join us at the Bella Center on Monday evening for a networking banquet reception which will provide the perfect opportunity to network with other conference participants in a relaxing environment. Other Networking Opportunities: • The EuroMeeting’s Exhibition Floor, with over 200 exhibitors, is a great place to network. All refreshment breaks take place on the Exhibition Floor, so it is easy to meet colleagues and friends (Monday-Wednesday) • Student Networking Reception (Sunday) • Speed Networking (Monday) • New to the pharmaceutical profession? The EuroMeeting offers young professionals a specific networking reception (Monday) • All attendees get together for a drinks reception on the Exhibition Floor after sessions finish for the day (Tuesday) • DIA’s Special Interest Area Communities (SIACs) Networking Lunch. SIACs offer a discipline-specific global community where members can share experiences and knowledge, find common ground, and network with others in their fields. SIAC activities are an integral part of the EuroMeeting (Tuesday) • Patient Representatives are supported each year by DIA to attend the EuroMeeting where attendees will have a chance to meet them and listen to their priorities and concerns • The EuroMeeting brings together expertise and viewpoints from different countries/regions of the world including Turkey, the Middle East, Japan, Africa, Eastern Europe, Russia, Latin America and India. The Reception for the Regions provides an opportunity for attendees who work in or with these countries/regions to network (Wednesday)

EUROMEETING 2012 GLOSSARY AIDS............................... Acquired Immune Deficiency Syndrome

FDA................................ U.S Food and Drug Administration

ATMP............................. Advanced Therapy Medicinal Product

GHTF.............................. Global Harmonisation Task Force

BfArM............................ Federal Institute for Drugs and Medical Devices, Germany

GLP................................. Good Laboratory Practice

CHMP............................. Committee for Medicinal Products for Human Use

GMP................................ Good Manufacturing Practice

CIOMS............................ Council for International Organisations of Medical Sciences

HMA............................... Heads of Medicines Agencies

CMC................................ Chemistry, Manufacturing & Controls

HTA................................ Health Technology Assessment

EATG.............................. European AIDS Treatment Group

IMI................................... Innovative Medicines Initiative

eCTD.............................. Electronic Common Technical Document

LLC................................. Limited Liability Company

EMA................................ European Medicines Agency

NeeS.............................. Non-eCTD electronic Submissions

EMACIS......................... European Medicines Agency Compliance Implementation

PASS.............................. Post-authorisation safety Study

PDCO............................. Paediatric Committee, European Medicines Agency

Services

EnprEMA...................... European Network of Paediatric Research, European

PSUR.............................. Periodic Safety Update Report

RPS................................. Regulated Product Submission

Medicines Agency

ePRO.............................. Electronic Patient Reported Outcomes

R&D .............................. Research and Development

EURORDIS.................... Rare Diseases Europe

SOP................................ Standard Operating Procedures

DIA................................. Drug Information Association

WHO.............................. World Health Organisation

ABOUT THE DIA EUROMEETING The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 attendees from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations. This convergence affords participants the opportunity to network with professional colleagues from around the world. The DIA is a 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.

ABOUT COPENHAGEN Copenhagen is a compact city with most hotels, restaurants and sights within easy walking distance of the centre. Its excellent infrastructure, accessibility, low crime rate and wide range of things to see and do all contribute to why it is the 6th most popular convention city in the world hosting over 100 international conventions each year. Visit one of its many world class art galleries such as the Louisiana, visit the Little Mermaid, have fun in the Tivoli Gardens amusement park in the heart of the city, shop on Strøget - Europe’s longest city pedestrian street - or enjoy a beer (Carlsberg of course) in one of the many cafes by the canal in Nyhavn. Copenhagen is a royal capital with the monarchy in Denmark being one of the oldest in the world. Copenhagen Airport has direct connections to a total of 132 destinations worldwide, 19 of which are intercontinental, 84 European, 22 Nordic and seven domestic. Located only 10 kilometres away from the city centre, transit time is just 15 minutes by train, Metro or taxi. All major European road and rail networks connect to Copenhagen through bridges or by way of ferry services.

QUICK FACTS ABOUT COPENHAGEN • Location: Copenhagen is the capital of Denmark, the most southern country in Scandinavia, forming a gateway between mainland Europe and the Baltic countries. • Population: 1.2 million. • Language: Danish (almost all Danes speak English). • Currency: Danish krone (DKK). • Accommodation: Approximately 19,000 hotel rooms. • Transportation: Excellent public transportation. Copenhageners love to cycle and pedal more than 1.13 million kilometres a day! Wonderful Copenhagen® is the official convention, event and visitors bureau of the Greater Copenhagen area. More information on Copenhagen can be found at: www.visitcopenhagen.com.

ABOUT THE CONVENTION CENTRE The Bella Center is Scandinavia’s largest exhibition and conference centre. Having its own Metro station, it offers easy access to the rest of the city. In recent years it has hosted a number of high profile events including the United Nations Climate Change Conference and the 121st International Olympic Committee (IOC) Session during which Rio de Janeiro was selected to host the 2016 Olympics. Its conference facilities make it an excellent venue for the 24th Annual DIA EuroMeeting and an event not to be missed.

Network with Professional Colleagues Anywhere Anytime!

DIA ConneX You DIA’s new membersonly social networkingstyle website is a vital resource for professionals like you looking to connect with others in your field and improve your job performance.

Thousands of your colleagues will be part of DIA ConneX, so don’t get left behind.

How Can DIA ConneX Help You? • Get answers to on-the-job questions • Access shared resources such as white papers and articles • Network with thousands of your colleagues worldwide

Get connected at www.diahome.org/DIAconnex.

REGISTRATION FORM

ID # 12101

24th Annual EuroMeeting 26-28 March 2012 | Bella Center, Copenhagen, Denmark

If DIA cannot verify your membership upon receipt of registration form, you will be charged the non-member fee. Registration fee includes lunch and coffee breaks

Early-Bird rates available for Members: Deadline by 27 January 2012

Early-Bird Industry Fee for members (by 27 January 2012)*

€ 1’675.00 

Join DIA now to qualify for the early-bird member fee! To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/non-profit members

Join DIA now to qualify for the member rate

€