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EUROMEETING Berlin 2009 PRELIMINARY PROGRAMME

MARCH 23-25, 2009 INTERNATIONALES CONGRESS CENTRUM BERLIN, GERMANY 21st DIA Annual EuroMeeting Programme Committee

Theme Leaders

Valdo Arnera Sabina Hoekstra-van den Bosch Monika Pietrek General Manager- Europe, Senior Advisor, Ministry of Health, MD PhD, MSc, Germany PHT Corporation, Switzerland Welfare and Sport, The Netherlands

Peter Bachmann Wills Hughes-Wilson Gabriele Schwarz Senior Expert European Affairs, Director Health Policy Europe, Head, GCP Inspection Services BfArM, Germany Genzyme, Belgium BfArM, Germany

Norbert Clemens Alar Irs Dagmar Stará Head Clinical Development, CRS Deputy Director, State Agency Head of Registration Unit, State Mannheim GmbH, Germany Medicine, Estonia Institute for Drug Control, Slovak Republic

Suzy de Cordt Suzette Kox Barbara Sickmüller Group Leader, Senior Project Manager, Senior Director, Scientific Affairs, Deputy Director General, German Merck Serono, Switzerland EGA, Belgium Pharmaceutical Industry Association, Germany

Nikos Dedes Jürgen Kübler Linda Surh no picture Co-chair, Patients' and Consumers' Global Head Integrated Safety and no picture Director, CEDD Global Regulatory available Working Party (PCWP), EMEA; Health Economics Biostatistics, available Affairs, Neurology and Chairman Board of Directors, EATG, Novartis Pharma AG, Switzerland Pharmacogenetics, GloxoSmithKline, EU UK

Kerstin Franzén Yann Le Cam Peter Stokman Senior Director Worldwide Regulatory CEO, EURORDIS, France Senior Director Clinical Data Policy and Intelligence, Pfizer AB, Management, Organon Schering- Sweden Plough, The Netherlands

Helen Van den Dungen Andreas Grund Christine Mayer-Nicolai Clinical Quality Assurance, Global General Manager, GCP-Service, Regulatory Coordination Europe and Head Country Management, Germany Global Regulatory Intelligence, Merck Novartis Pharma Services, KGaA, Germany The Netherlands

Bert Haenen Carolin Miltenburger John Wise Toxicologist, Organon Schering- Director Health Economics and Senior Director, Informatics, Daiichi Plough, Outcomes, i3 Innovus, Germany Sankyo, UK The Netherlands

Robert Hemmings Klaus Olejniczak Michael Zuehlsdorf no picture Statistics Unit Manager, MHRA, UK Scientific Director, BfArM, Germany no picture Biomarker Development Global available and CHMP available Head, Novartis Pharma AG, Switzerland

About the DIA EuroMeeting

The Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic research centres, regulatory agencies, health ministries, patients organisations and trade associations. This convergence affords attendees the opportunity to network with professional colleagues from around the world.

The DIA is a professional association of approximately 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. We are committed to the broad dissemination of information on the development of new medicines or generics and biosimilars, with continuously improved professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itself from meeting and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications at reasonable, competitive costs. Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior Event Manager (EuroMeeting) at DIA Europe: [email protected]. Welcome from the EuroMeeting 2009 Co-Chairs - Barry Burnstead and Dr. Susanne Keitel

Dear Colleague,

We were delighted to be invited by the DIA to chair the 2009 EuroMeeting and particularly enthused by the location selected, Berlin. Delight turned to apprehension as the responsibilities associated with co-chairing became clear. Nevertheless, our resolve is firm and our determination to build upon the success of 2008 unquestioned. The theme approach was very well received in Barcelona and will be retained in Berlin. Certain refinements around the theme sessions have been identified that will support the quest to have all disciplines interacting at our event.

Alongside the traditional areas of drug development, regulation and patient safety, our desire is to broaden the appeal of the EuroMeeting by introducing complimentary topics. Information technology has established itself in a role that is unquestionable, central to all our activities and this will be reflected as a prominent theme in the programme. The vital importance of appreciating the patient’s perspective on drug information will feature strongly and the connection between the worlds of drugs and medical devices will be strengthened, by once more tackling the challenging subject of combination products.

The key to a successful event is for the organising committee to construct a programme that truly represents our member’s interests. This year’s organising committee has performed impressively and has already demonstrated commitment complimented by high levels of expertise. All of us are eager to listen and learn about what subjects are receiving your attention today. Feedback is vital to the process and we can amalgamate all this information into what we intend to be an irresistible programme. Tough decisions will confront us along the way as the selection process can be challenging. However, we take the responsibility bestowed upon us by the DIA seriously and will apply our judgment fairly to ensure that we embrace popular opinion and key interests as comprehensively as possible.

Our sights are firmly focused on Berlin in March 2009 with the clear target of delivering an event that not only fulfils but actually exceeds your expectations. See you there.

Barry Burnstead Consultant, UK Barry Burnstead has worked in the pharmaceutical industry for 35 years. Formative years were spent in chemistry, project management and biometrics at SmithKline Beecham. He entered the CRO world in 1991, and a year later with colleagues founded a CRO in Germany and established CRUs in Sweden and the UK. In 1999, he decided to concentrate on consulting and joined Domain Pharma. When Phase Forward acquired Domain, he became global Head of Programme Management. Barry joined i3 Statprobe in August 2006 as Director of Project Management and after one year moved to a central role in leading standards implementation. Since May 2008, Barry has been working as an independent consultant.

Dr. Susanne Keitel

Director, European Directorate of the Quality of Medicines and Healthcare (EDQM), EU Dr. Susanne Keitel joined BfArM in 1997 after 10 years in pharmaceutical development in industry. In the following 10 years with BfArM, she held, amongst others, the positions of Head of Pharmaceutical Quality and Head of EU, International Affairs. She has been a member of various EU working parties, including QWP, PEG, NtA, and, on an international level, ICH Expert Groups. Since October 2007, Susanne is Director of the Council of Europe’s European Directorate for the Quality of Medicines and HealthCare (EDQM).

Programme Advisors

Christelle Anquez-Traxler Hans-Georg Eichler Angelike Joos Fergus Sweeney Regulatory and Scientific Affairs Senior Medical Officer, EMEA, EU Regulatory Policy Europe, Merck Principal Scientific Administrator, Manager, AESGP, Belgium Sharp and Dohme (Europe) Inc., GCP and Pharmacovigilance Ralf Eulentrop Belgium Inspector, EMEA, EU Christer Backman Project Head of Leadership Training, EU Coordinator, Senior Expert, MPA Merck Serono, Switzerland Ingrid Klingmann Joachim Vollmar Sweden President, Pharmaplex, Belgium Executive Consultant, International Christoph Gleiter Clinical Development Consultants, Gerd Bode Director Coordination Centre for Marisa Papaluca Amati USA Consultant, Germany Clinical Trials, University Hospital Deputy Head of Sector, Safety and Tübingen, Germany Efficacy of Medicines, EMEA, EU Ralph White Klaus Cichutek Director, PPMLD Ltd, UK Head, Department of Medical Wills Hughes-Wilson Francesco Pignatti Biotechnology, Director, Health Policy Europe, Scientific Administrator, Safety and Beat Widler Paul-Ehrlich-Institute, Germany Genzyme, UK Efficacy of Medicines, EMEA, EU Global Head, Clinical Quality Assurance, Hazel Collie David Iberson-Hurst Johan Pröve F. Hoffman-La Roche Ltd, Global Head, Project Management, Vice President, Technical Strategy, Global Head, Data Management, Switzerland Gruenenthal GmbH, Germany CDISC, UK Bayer Schering Pharma, Germany Matthias Wilken Rosalind Coulson Michael James Per Spindler Head of Drug Regulatory Affairs PhC, MSc, FR, PharmS, UK Head of CMC Policy and Head, Director, BioLogue, University Europe, Association of the German Intelligence, GlaxoSmithKline, UK of Copenhagen, Denmark Pharmaceutical Industry, Germany Joseph DeGeorge Vice President Safety Assessment, Truus Janse-de Hoog Ursula Streicher-Saied Merck and Co, UK Staff Member Chair, European Head of Global R and D Quality, Cluster, Chair CMD(h), Medicines Bayer Health Care, AG, Germany Evaluation Board, The Netherlands 1 THEMES AND TOPICS FOR 2009

Theme 1 Audits and Inspections Gabriele Schwarz, Head, GCP Inspection Services BfArM, Germany Helen Van den Dungen, Clinical Quality Assurance, Global Head Country Management, Novartis Pharma Services, The Netherlands

Theme 2 Regulatory Challenges and Controversies - Balancing Access with Safety and Affordability Aspects Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Intelligence, Pfizer AB, Sweden Dagmar Stará, Head of Registration Unit, State Institute for Drug Control, Slovak Republic

Theme 3 Clinical Research – Increased Complexity by Integration of Real Life Settings Norbert Clemens, Head Clinical Development, CRS Mannheim GmbH, Germany Alar Irs, Deputy Director, State Agency Medicine, Estonia

Theme 4 Safety throughout the Product Life-Cycle: Strategies to Better Protect Public Health Monika Pietrek, MD PhD, MSc, Germany

Theme 5 Knowledge Management John Wise, Senior Director, Informatics, Daiichi Sankyo, UK

Theme 6 Medical Device Drug Combination: The Medical Opportunities and Regulatory Challenges of the 21st Century Andreas Grund, General Manager, GCP-Service, Germany Sabina Hoekstra-van den Bosch, Senior Advisor, Ministry of Health, Welfare and Sport, The Netherlands

Theme 7 Project Management in a Changing Environment Suzy de Cordt, Group Leader, Senior Project Manager, Merck Serono, Switzerland

Theme 8 Media, Society and Research Nikos Dedes, Co-chair, Patients' and Consumers' Working Party (PCWP), EMEA; Chairman Board of Directors, EATG, EU Yann Le Cam, CEO, EURORDIS, France

Theme 9 Future of Drug Development, Manufacturing and Globalisation - Important Trends and Hot Topics Barbara Sickmüller, Deputy Director General, German Pharmaceutical Industry Association, Germany Christine Mayer-Nicolai, Regulatory Coordination Europe and Global Regulatory Intelligence, Merck KGaA, Germany

Theme 10 Impact of Technology and Standards on Drug Development: Now Better, Safer and Faster? Peter Stokman, Senior Director Clinical Data Management, Organon Schering-Plough, The Netherlands Valdo Arnera, General Manager Europe, PHT Corporation, Switzerland

Theme 11 Optimising Drug Development through Sound Methodology Jürgen Kübler, Global Head Integrated Safety and Health Economics Biostatistics, Novartis Pharma AG, Switzerland Robert Hemmings, Statistics Unit Manager, MHRA, UK and CHMP

Theme 12 Health Economics and Health Technology Assessments Supporting Sustainable, Socially Acceptable and Equitable Access to Innovation Wills Hughes-Wilson, Director Health Policy Europe, Genzyme, Belgium Carolin Miltenburger, Director Health Economics and Outcomes, i3 Innovus, Germany

Theme 13 Preclinical-clinical Interface: How to Improve Success in Developing Innovative Medicines Bert Haenen, Toxicologist, Organon Schering-Plough, The Netherlands Klaus Olejniczak, Scientific Director, BfArM, Germany

Theme 14 Personalised Medicine in Drug Development: Adding Value with New Tools - Biomarkers, Health Economics and Diagnostics Michael Zuehlsdorf, Biomarker Development Global Head, Novartis Pharma AG, Switzerland Linda Surh, Director, CEDD Global Regulatory Affairs, Neurology and Pharmacogenetics, GloxoSmithKline, UK

Theme 15 Regulatory Developments and Availability of Biosimilar, Generic, and Self-Care Medicines Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium Peter Bachmann, Senior Expert European Affairs, BfArM, Germany

European Regulatory Forum Brenton James, Strategic Regulatory Affairs in the European Union, Consultant, UK Thomas Kühler, Director, Operations, MPA, Sweden 2 2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Confirmed Session Chairs include: Serious GCP Breaches Including Falsification and Fraud

Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, Quality Risk Management and Risk Detection AESGP, Belgium Peter Bachmann, Senior Expert European Affairs, BfArM, Germany Audits and Inspections of Quality Aspects of Advanced Therapy Products Glyn Belcher, Vice President Drug Safety and Risk Management International, Biogen Idec Ltd., UK Audits and Inspections of Data Analysis Mike Branson, Global Statistical Methodology Head, Novartis Pharma AG, Switzerland Summary of the ‘Roundtable/Workshop on GCP Inspection and Audit Norbert Clemens, Head Clinical Development, CRS Mannheim GmbH, Findings Germany Rosalin Coulson, PhC, MSc, FR, PharmS, UK Andrzej Czarnecki, Director, Deputy Qualified Person For Pharmacovigilance, Theme 2 Global Product Safety, Eli Lilly and Company Ltd., UK Regulatory Challenges and Controversies - Balancing Access with Joseph de George, Vice President, Safety Assessment, Merck and Company, Safety and Affordability Aspects Inc., USA Kerstin Franzén, Senior Director Worldwide Regulatory Policy and Sarah Daniels, Manager UK Drug Surveillance, Roche Products Ltd., UK Intelligence, Pfizer AB, Sweden Helen Darracott, Director of Legal and Regulatory Affairs, PAGB, UK Dagmar Stará, Head of Registration Unit, State Institute for Drug Control, Nancy Dreyer, Senior Vice President, Chief Scientific Affairs, Outcome, USA Slovak Republic Bernd Eberwein, Managing Director, BAH, Germany Vicki Edwards, Senior Director European Pharmacovigilance, Abbott Efforts are made today to bring new treatments to the market in a timely Laboratories Ltd., UK manner especially in areas where there are no or insufficient treatments Sandy Eisen, Chief Medical Officer, TEVA Europe, UK available. At the same time, safety awareness is key and an increasingly Christoph Gleiter, Head, CenTrial GmbH, Germany growing notion. Another factor to consider is the affordability of medical Walter Haefeli, Medical Director University Heidelberg, Germany treatments. The early access to new treatments must be sensibly balanced Bert Haenen, Toxicologist, Organon Schering-Plough, The Netherlands with safety considerations and affordability aspects in order to safeguard Jürgen Kübler, Global Head Integrated Safety and Health Economics public health. This is the vision for the theme as these aspects have important Biostatistics, Novartis Pharma AG, Switzerland implications for the regulatory environment and impact the regulatory Cecil Nick, Principal Consultant, Parexel Consulting, UK process. The sessions of the theme will discuss different factors playing into Klaus Olejniczak, Scientific Director, BfArM, Germany this equation, such as new pharmacometric approaches and the related Susana Perez Gutthann, Vice President, Global Head, RTI Health Solutions, regulatory dialogue, the benefit – risk aspects and how to communicate this Spain in a way that can be understood by the lay people, cost aspects, and highlight Monika Pietrek, MD PhD, MSc, Germany the regulatory challenges connected with this. Andreas Reimann, CEO, Cystic Fibrosis Association, Germany Mike K. Smith, Director Pharmacometrics, Pfizer, UK Balancing Access with Safety and Affordability Aspects Beata Stepniewska, Director Regulatory Affairs, EGA, Belgium Holger Rohde, Manager Medical Affairs, PharmaLex GmbH, Germany Involving Regulators in Novel Drug Development Heike Schön, Managing Director, CSG, Germany Beatriz Silva-Lima, Professor, Pharmacology, CHMP and SAWP member, Novel Pharmacometric Approaches SWP Chair, University of Lisbon, INFARMED, Portugal Joachim Vollmar, Executive Consultant, International Clinical Development Benefit - Risk Consultants, USA Richardus Vonk, Head of Drug Discovery Statistics, Bayer-Schering Pharma Enabling Early Access AG, Germany Health Technology Assessment and Patient and Payer Influence on the Regulatory Process Theme 1 Audits and Inspections Communicating Benefit - Risk to the Public Gabriele Schwarz, Head, GCP Inspection Services BfArM, Germany Helen Van den Dungen, Head, GCP Inspection Services, Novartis Pharma Regulatory Consequences of Outsourcing Clinical Development and Services, The Netherlands Manufacturing to India, China

Sponsors of clinical trials as well as their contractual partners are forced to implement effective quality assurance and quality control arrangements in order to meet the growing expectations regarding quality of clinical trials and products. These arrangements need to cover a wide range of facilities, functions and processes. In the theme “Audit and Inspections”, experiences on specific topics such as audits and inspections of e-CRFS and e-source data, data analysis, pharmacovigilance and quality aspects of Advanced Therapy Products, will be shared. The presentations will also cover challenges related to the delegation of sponsor functions to CROs and other third parties, quality risk management tools and issue escalation. As more and more products are developed and marketed in a global setting, ethical and quality standards need to be harmonised to enable the effective planning and execution of clinical trials, audits and inspections. Representatives from EU-, US- and other Third Country Regulatory Authorities will discuss their international GCP inspection programs, procedures and experiences. Throughout the last years, European Competent Authorities have obtained information more often about serious GCP breaches including falsification and fraud. One session will discuss sponsor, investigator and patient responsibilities and how to detect, report and avoid those cases.

International GCP Inspection Experiences (Reps from European/Chinese Authorities and Industry)

Audits and Inspections on Pharmacovigilance in Clinical Trials

Audits and Inspections on E-CRF’s and E-Source Data

Delegations of Sponsor Functions to CROs and other Third Parties 3 2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 3 Surveillance: Diseases and Pharmacovigilance – How Good Are Our Baseline Clinical Research – Increased Complexity by Integration of Real Life Data? Settings Norbert Clemens, Head Clinical Development, CRS Mannheim GmbH, EU harmonised Pharmacovigilance Requirements versus Global Germany Pharmacovigilance - Supplement or Contradiction? Alar Irs, Deputy Director, State Agency Medicine, Estonia Special Requirements for the Safety of Biologicals and Biosimilars Everybody has to focus on relevant patient data today, as these are the driving forces for licensing, treatment and reimbursement decisions. Randomised Safety Decision-making – How much Science is Deployed? An Update on clinical trials of good quality represent the most scientifically valid study design Methodology for evaluating the safety and efficacy of new medical treatments. However, for patient relevant data, the usual pivotal clinical trial in its current form may Performance and Quality Control in Pharmacovigilance and Risk Management not always represent the most appropriate tool for generating information on – Too Much or Too Little? the safety and cost-related issues of medical treatments. Recently a patient group started an open and non-blinded, patient-driven trial, an approach that Safety Surveillance Plans: Strategies for Monitoring Safety during the has amazing potential but increased risks. Another hot topic is first-in-man Development Lifecycle studies with biologicals post TGN1412. Considerable effort has been put into providing guidance, which now needs to be transferred into practice. The Drug Safety Personnel – Which Qualification and How Much Education is requirements for paediatric studies have not completely arrived at the Needed? Where Do Regulators and Industry Find Talent? operational level of clinical development. The sessions of this theme will discuss these and other topics of current interest in the clinical field and will Post Authorisation Studies – Commitments and Reality provide up-to-date guidance on future clinical research.

Paediatric Trials Theme 5 Knowledge Management Patient Reported Outcomes John Wise, Senior Director, Informatics, Daiichi Sankyo, UK

Strategy of Clinical Development This theme, broad in scope will consider knowledge management (KM) across the Pharma RandD value chain from clinical candidate selection through to First-in-Man Studies dossier submission and review. It sets out to provide value for senior management wishing to catch the key strengths and concerns of the Patient Recruitment discipline while providing KM practitioners with a state-of-the-art update on the status of their discipline, its opportunities and future direction. Novel Approaches in Clinical Research Key topics will be covered, ranging from a review of current standards appropriate to KM and their near-term evolution, through mandatory and Multinational Trials in China, Africa and South America desirable “electronic” procedures with the EMEA and European National Competent Authorities, including a detailed assessment of the status and use Infectious Diseases of the eCTD and PIM. The urgent need better to integrate and mine phenotypic and genotypic information during drug development will be addressed. The potential for exploitation of KM to optimise the myriad Theme 4 processes supporting product cross-licensing will be examined by industry Safety throughout the Product Lifecycle: Strategies to Better Protect experts. The challenge to exploit knowledge throughout the drug Public Health development lifecycle to support the construction of drug risk management Monika Pietrek, MD PhD, MSc, Germany plans - now an essential part of a marketing application – will be covered, leading up to a tour d'horizon of how effective innovation – so sorely needed In December 2007 the European Commission launched a public consultation in today’s hard-pressed biopharmaceutical industry - can be encouraged, on a strategy to better protect public health by strengthening and initiated and enabled by KM. rationalising EU Pharmacovigilance. This is the latest of several regulatory The theme will culminate in a key-note concluding address challenging the initiatives to improve the safety of medicinal products. Both health authorities participants to consider the validity of the cry “the Chief Information Officer and the pharmaceutical industry have endeavoured to regain the confidence is dead, long live the Chief Knowledge Officer!” of the patients as well as the public. The different aspects identified should contribute to safer products: better understanding of disease mechanisms are The EU Knowledge Management Landscape aimed at the development of personalised medicines, specific risk minimisation activities and increased scrutiny of post authorisation The "Electronic-only" Centralised Procedure commitments additionally will support the protection of patients and consumers. Also the role of consumer reports has been recognised in the EU, Towards "Electronic-only" Mutual Recognition, Decentralised and National which may provide further insight into the effects of medicinal products when procedures. exposed to large populations. While industry and regulators are implementing the new regulatory requirements, globalisation and exploding costs of drug PIM (Product Information Management) development and healthcare are the other major forces requiring pharmaceutical and biotechnology companies to readjust their working Knowledge Management in Drug Development practices. Off-shore working, outsourcing and new technologies are considered to provide adequate solutions to such challenges. However, the Knowledge Management and Product Cross-licensing impact of these changes will only be measurable after a number of years of experience. Therefore, it is important that the major stakeholders agree on Knowledge Management: An Essential Component of Risk Management and common objectives in support of public health. In particular, societies need to Pharmacovigilance determine which treatments should be provided and how they wish to balance benefits, risks and costs. Though public health and the availability of Knowledge Management and Innovation. medicinal products remain a national responsibility, the safety of medicinal products is determined globally through e.g. clinical development, manufacturing, marketing and surveillance. The regulators in US and EU have acknowledged the need for harmonisation and simplification. The progress, however, will depend on the scope of such efforts and the timeframe for implementation as well as on the involvement of health authorities in other jurisdictions, the involvement of other stakeholders and ultimately on effective communication.

4 2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 6 Using Project Management to Improve Quality Medical Device Drug Combination: The Medical Opportunities and Regulatory Challenges of the 21st Century How to Capitalise on Knowledge-generated Products Andreas Grund, General Manager, GCP-Service, Germany Sabina Hoekstra-van den Bosch, Senior Advisor, Ministry of Health, Welfare and Sport, The Netherlands Theme 8 Media, Society and Research The pharmaceutical and the medical devices sectors could be considered as Nikos Dedes, Co-Chair, Patients' and Consumers' Working Party (PCWP), two separate sectors, which differ in history, culture, organisational structure, EMEA, EU legislation and even in language. However, since the traditional boundaries Yann Le Cam, CEO, EURORDIS, France between medical devices and drugs are blurring, there is a need for improvement of the communication between the two sectors. Nowadays, the Theme summary unavailable at time of going to press pharmaceutical and the device worlds meet each other in the combination products of drugs and devices and in the so-called ‘borderline products’. This Enhancing Public Trust in Drug Research theme will analyse the current similarities and differences between the drug and the device regulatory systems and will focus on possibilities for working Sensational Media Coverage - Risk communication / Risk Management / together both on operational and regulatory levels, e.g. in clinical research, in Science Communication adverse event reporting and in market access. This theme will also reflect the most recent developments in device regulation, such as the changes resulting Transparency for Research Outcomes, Competitiveness and Trust from EU-Directive 2007/47 and from more recent initiatives. New and emerging technologies will have a huge impact on product development in Between "Pull" and "Push" Information: Where Do Patients really Stand? both the pharmaceutical and the device sector and will result in many new Direct to Consumer Information. Information to Patients Policy Debates. products, some of which will be difficult to characterise as either a pharmaceutical or a medical device. Also new and emerging technologies Real Life Experience on Patient Involvement on Patient Information? could result in a ‘therapeutic shift’ from drugs to devices and vice versa. This theme will highlight some interesting developments in implants and Society, Patients and Advanced Therapies inhalation therapy. This theme will proactively consider what efforts need to be made to harmonise the sectors and how the future regulation of Future of EU Pharmaceutical Legislation and EU Pharmaceutical Market: An pharmaceuticals and of devices could be developed in order to offer the ‘best Opportunity to Present our Respective Views of both worlds’ to both pharmaceuticals and medical devices. Innovative Public Policy to Improve Access to New Medicines New and Updated Regulations: How Do They Affect Medical Device Drug Combinations? Theme 9 How to Develop/Change SOPs for Drug Device Combinations: What Impact Future of Drug Development, Manufacturing and Globalisation – Does Device Development Have on a Pharmaceutical Company Important Trends and Hot Topics Barbara Sickmüller, Deputy Director General, German Pharmaceutical Quality Assurance Systems for Drug Device Combination Manufacturers: Industry Association, Germany Experiences of QA Manager and Auditors Christine Mayer-Nicolai, Regulatory Coordination Europe and Global Regulatory Intelligence, Merck KGaA, Germany Inspection Findings on Investigational Sites and at the Sponsor of Drug Device Combination Trials Theme summary unavailable at time of going to press Drug and Device Safety: How to Combine Reporting Requirements Therapeutic Vaccines Expanding our Horizons to Deliver Device and Drug Combination Products Implementation of ICH Q8, Q9, Q10 Successfully to Market Added Therapeutic Value New Developments in Drug Delivery Implants: How much Do They Benefit the Current Cancer Therapy? Further Development of EDQM Diagnosis-treatment Combinations (Theranostics) and New Inhalation OTC Medicinal Products Technologies Innovative Technologies Parallels between Pharma 'Quality by design' (ICH 8-9-10) and Device Relevant GHTF Documents Advanced Therapies Roundtable: The Spirit of One Team Created from Two Worlds – the Key to Drug Counterfeiting Successful Development of Devices/Drug Combination Products. Developments in ICH

Theme 7 Project Management in a Changing Environment Suzy de Cordt, Group Leader, Senior Project Manager, Merck Serono, Switzerland

Driving drug development projects forward is at the heart of a pharma/biotech company, and it is a challenge in a world where the only constant is change. Project Management (PM) is a key success factor. The key is to rigorously plan and monitor timelines and budget and coordinate the wide cross-functional scope of expertise, whilst staying lean, fast, agile and strategically focused. This theme will offer a forum to exchange views on how Project Managers and PM tools and processes can help to successfully deliver projects on time and budget and meeting quality standards, and how to capitalise on knowledge generated in projects.

Project Manager - Leader or Coordinator?

Project Management Tools - A Help or Hindrance? 5 2009 THEMES - APPROXIMATELY 120 SESSIONS IN TOTAL OVER THREE DAYS

Theme 10 Theme 12 Impact of Technology and Standards on Drug Development: Now Health Economics and Health Technology Assessments – Supporting Better, Safer and Faster? Sustainable, Socially Acceptable and Equitable Access to Innovation Peter Stokman, Senior Director Clinical Data Management, Organon Wills Hughes-Wilson, Director Health Policy Europe, Genzyme, Belgium Schering-Plough, The Netherlands Carolin Miltenburger, Director Health Economics and Outcomes, i3 Valdo Arnera, General Manager Europe, PHT Corporation, Switzerland Innovus, Germany

Over the last few years, electronic data capture ( eCRF, ePRO, IVRS/IWRS, etc.) Growing budget constraints in healthcare worldwide increasingly determine rapidly and dramatically changed clinical drug development. At the current market access and new medical technologies. Evidence of product value is speed of EDC adoption, by the end of this decade the paper trial may have critical to meet the requirements of reimbursement agencies, clinical guideline become extinct. However, neither the ‘loose ends’ in EDC nor the interfacing committees but also the expectations of patients and physicians. Product of the many systems involved make for an optimal process yet, which impedes value goals are therefore essential development objectives, equal in the leap from ‘using EDC’ to true eClinical. Rigorous standardisation is one of importance to safety, efficacy and quality. ten years after the introduction of the answers. The various CDISC models offer an end-to-end solution in which NICE into the European landscape almost all EU countries have established the use of standards can bring an unprecedented streamlining of data flows, processes and standards for HTA and economic appraisal. The theme will encompassing the healthcare community, investigational sites, pharma explore the European health policy environment and the various companies and regulators. Although most companies are able to provide methodologies used to build a product value platform as part of drug regulators with data in SDTM format, the tremendous improvements the development. The theme aims to cover different phases of the product various CDISC models can bring remain largely untapped. Both EDC and lifecycle, different perspectives and novel approaches. The theme aims to be CDISC are causing a paradigm shift regarding efficiency and quality in clinical a forum to exchange and discuss experience and to participate in the search development. This theme will give us a sense of where we are, and a vision for best practice. of where we are headed. Health Economics and Health Technology Assessment in 2009–AMore Regulatory Acceptance of eSource. Challenging the Regulatory Requirements. Diverse or More Uniform Landscape? Practical Examples. The New EMEA Guidance in Application Access to Innovation: A Role for New Approaches? Ins-and-Outs of Integration: Needs and benefits of integrating different eClinical data streams e.g. ePRO, lab, ECG, EDC, end user considerations and Market Access in Europe: How Does Innovation Get to the Patients? examples Demonstrating Cost-effectiveness in Challenging Situations and when Data is Technology and Standards…How about the Process? Limited The Loose Ends in EDC and How to Address Them Conditional Marketing Authorisations – Managing Health Technology A Look into the Future: What Is on the Horizon after We Managed EDC Assessments in a Conditional environment Properly? Building HTA into Product Development for Success Using Electronic Health Records in Clinical Development: Theory and Practice Medicines are about More than Money. Building Social Values into Health Experience with CDISC Models Economics CDISC End-to-end: To What Extent? Clinical Trials: The Start not the End. Building Integrated Data Sets in a CDISC as an Avenue to Process Improvement European Context to Meet the Needs

What Does the User Consider Value? Including the Patients’ Voice in Theme 11 Assessments Optimising Drug Development through Sound Methodology Jürgen Kübler, Global Head Integrated Safety and Health Economics Biostatistics, Novartis Pharma AG, Switzerland Theme 13 Robert Hemmings, Statistics Unit Manager, MHRA, UK and CHMP Pre-Clinical-clinical Interface: How to Improve Success in Developing Innovative Medicines The current RandD process is facing significant challenges: there is a need to Bert Haenen, Toxicologist, Organon Schering-Plough, The Netherlands develop efficacious and acceptably safe drugs more efficiently, and to improve Klaus Olejniczak, Scientific Director, BfArM, Germany in the early identification of drugs that will ultimately fail to prove a favourable profile of benefits and risks. Sound quantitative methods can play Preclinical studies are generally used to explore initial safety, pharmacology a major role in optimising drug development in terms of both design and and pharmacokinetic behavior of new medicinal products before entering conduct of an individual study, and design and decision-making across a clinical studies. Even after reaching the clinical stage of development , development programme. The theme will explore statistical approaches to preclinical testing continues. In pre-clinical RandD, researchers are improve the efficiency with which medicines are developed. This includes a continuously searching for new techniques, targets, safety endpoints, animal thorough discussion of how to optimise implementation of established and models etc. to improve the predictivity of animal studies for the clinical new methodology and their applicability in a highly regulated environment. situation. One session focuses on juvenile animal studies for first in children The theme aims to provide a forum for discussion between industry, academic trials; a session chaired by Beatriz Silva Lima, chairperson of EMEA-SWP. and regulatory thought-leaders. Relevant experience will be shared and Another session focuses on the safety and efficacy of the new emerging area discussed, reflecting on lessons learned. By investigating the underlying of RNAi therapeutics. processes, recommendations for best practice will be developed. Use of Imaging in Non-clinical Toxicity Testing: What Is its Value? What about Adaptive Designs I (Introductory/Impletation/Experience) Regulatory Acceptance?

Adaptive Designs II (Implementation/Experience) Non-clinical Evaluation of Hepatotoxicity: Where do We Stand? How Skeptic is Pharmaceutical Industry? Safety Planning, Evaluation and Reporting RNAi Therapeutics Safety and Nonclinical Efficacy Testing and Development Signal Detection (Statistics) First-in-Man Studies New Statistical Approaches in Preclinical Update on ICH S6 Guideline: Reprotox of Homologue Monoclonals. Is it Dose Finding Useful?

Clinical Scenario Assessment Update on ICH S6 Guideline: Safety Pharmacology and Long-term Tox Testing

6 Regulatory 2009 THEMES - ADDITIONAL SESSIONS - TUTORIALS

Update on Anticancer Drug Guideline and Nonclinical Requirements. Why Necessary? The Path towards a Global Biosimilar Program

Genotoxicity: Revision of ICH S2 and/or Impurities Guideline (staged TTC Patents and the EU Regulatory Systems approach). Why the Need to Revise? What are Current Industries’ Policies with Respect of Impurity Testing? “Smart Regulation” for Non-Prescription Medicines

Juvenile Animal Testing News on Rx to OTC Switch

Improved Market Access to Herbal Medicinal Products Theme 14 Personalised Medicine in Drug Development: Adding Value with New Tools - Biomarkers, Health Economics and Diagnostics Additional Sessions Michael Zuehlsdorf, Biomarker Development Global Head, Novartis Pharma AG, Switzerland In addition to the sessions contained in the 15 themes, there are many more Linda Surh, Director, CEDD Global Regulatory Affairs, Neurology and sessions in development to complete the programme: Pharmacogenetics, GloxoSmithKline, UK • Hot Topics Improved understanding of diseases, mechanisms of drug action and human • Stand-alone sessions such as the Japanese Regulatory session and the genome sequencing have raised public expectations for modern targeted German Satellite session medicines towards a personalised medicine approach. A doctor prescribing a • European Regulatory Forum sessions medicine to a patient might say she/he already practices ‘personalised medicine’, so this term may be just a ‘buzz’ word for them. A payer reimbursing the patient’s medicine might say that the economic pressures within the healthcare system must drive the future pharmaceutical market Tutorials towards individualised treatment to improve efficacy, value and safety. Yet how does anyone (whether regulator, industry researcher or medical This is a preliminary selection. Additional tutorials to be confirmed at practitioner) convert complex population data gathered over decades for one a later date. new drug into prescriber decisions and actions which tailor treatment for an individual. This theme covers key new tools in drug development, from 1. Detailed Description of Pharmacovigilance Systems for Medicinal emerging biomarkers to health economics, with a focus on how these may be Products for Human Use: Vol. 9A and EU Regulatory Requirements expected to meet the demands of the personalised medicine field. In turn, we will show how this creates specific challenges in the project management 2. Paediatric Development and Innovative Aspects of Paediatric Trials of a new drug by following benefit-risk assessments moving through specific regulatory environments such as drug-diagnostic co-development, health 3. Risk Management: Turn Plans into Practice economic evaluations and effective integration of biomarkers which need clinical validation. 4. The PSUR: A Pharmacovigilance and Medical Writing View with Emphasis on Practical Solutions to the Pitfalls and Grey Areas Personalised Medicine: Beyond the Buzzword 5. Analysis of Safety Data from Clinical Trials From Populations to Individuals: Industry Tools and Assessment of Benefit/Risk Balance 6. How to Deal with CP and MRP in an Enlarged EU

Personalised Medicine: A Challenge for Drug Development? 7. Interactions Between the Regulatory Regime and the Legal Principles Governing Intellectual Property, Competition and Regulatory Guidelines Compared to Medical Practice Guidelines: Their Places Product Liability for Non-lawyers in Personalised Medicine 8. Qualified Person for Pharmacovigilance: What Do You Need to Know? Theme 15 9. Health Economics and HTA – How to Demonstrate Product Value Regulatory Developments and Availability of Biosimilar, Generic, and Self-Care Medicines 10. Device Legislation for Pharmaceutical Oriented People Suzette Kox, Senior Director, Scientific Affairs, EGA, Belgium Peter Bachmann, Senior Expert European Affairs, BfArM, Germany

The regulatory environment is constantly evolving, bringing new opportunities but also new challenges which enhance the need for ongoing dialogue and adaptation by the regulatory authorities and industry. The sessions under this theme will discuss how industry and regulators can meet these various new challenges and improve the efficiency of the current regulatory system in order to increase the availability of biosimilar, generic and self-care medicines for the benefit of the patients. The individual sessions will particularly discuss the current initiatives to optimise the use of resources at the level of the national competent authorities and the pharmaceutical industry, the issues surrounding the introduction of biosimilar products into high prescribing areas, the feasibility of a global development program for biosimilar medicines, the scientific and regulatory perspective regarding second generation biosimilar products and patent linkage in the EU regulatory systems. The sessions on self-care will reflect on how access to non- prescription medicines, whether of chemical or herbal origin, may be improved by a better regulatory system taking into account the characteristics of these medicines.

Ways to Improve the Current Regulatory System for Assessment of Medicinal Products with Known Active Substances

Known Active Substances and Bibliographic Applications - Actual Problems, Possibilities and Solutions

Introduction of Biosimilar Medicines into Clinical Practice 7 BE A POSTER PRESENTER

Call for Student Poster Abstracts: Deadline November 21, 2008 Full-time university students, residents and fellows are invited to submit abstracts for the Student Poster Session which will take place on Tuesday, March 24, 2009 at the EuroMeeting in Berlin.

A total of EUR 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 students, residents or fellows at the time of the presentation. One author or the author’s designee must attend the EuroMeeting.

Benefits: • One fully supported registration for the EuroMeeting to include: return flight to Berlin, three nights hotel accommodation and complimentary registration for the EuroMeeting • A second complimentary EuroMeeting registration for an accompanying person • Accepted abstracts will be printed in an early 2009 issue of the Drug Information Journal • A total of EUR 1,800 in prize money

Abstracts: • All poster abstracts must be received by Friday, November 21, 2008. Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon. • Abstracts are limited to 100 words • A student may submit only one abstract • Abstracts may not refer to specific brand names • Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions • Submissions must include complete contact information • Abstracts will be reviewed and authors notified of results by Friday, December 12, 2008

Call for Professional Poster Abstracts: Deadline November 21, 2008 A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations to be held on Tuesday, March 24, 2009.

Selected professional poster presenters will be required to pay the applicable meeting registration fee and will be responsible for all other meeting expenses.

Abstracts: • All poster abstracts must be received by Friday, November 21, 2008. Submit your abstract online by going to www.diahome.org and clicking on the EuroMeeting icon. • Abstracts are limited to 100 words • Abstracts may not refer to specific brand names • Abstracts should follow a structured format including all of the following: objectives, methods, results, conclusions • Submissions must include complete contact information • Abstracts will be reviewed and authors notified of results by Friday, December 12, 2008

If you require further information about Student or Professional Posters, please contact Sandra Weber at DIA Europe: [email protected]

8 WHAT PAST EUROMEETING DELEGATES HAD TO SAY

“Very insightful; very experienced speakers”

“Good session; excellent chair”

"A very good proportion of decision makers on the exhibition floor makes EuroMeeting essential for our company"

EuroMeeting 2008 Attendees by Country/Region

"The meeting featured the most senior speakers from the various regulatory agencies of any congress I have been to"

“Detailed discussion of a broad and complex and changing area, by people directly controlling them or involved with them”

“Very good presentations – highly informative”

"Excellent networking and very well organised... good opportunities to ask questions after the sessions, speakers very approachable at DIA"

"Very practical, well balanced between authority, industry and patient view" 9 Showcase your company's products and services to more than 3,000 key decision makers - all in the one place, at the one time! Senior-level professionals at the EuroMeeting in Barcelona included:

1st Secretary Trade and Investment Director, Document Management Acting Deputy Head of Sector, Scientific Advice and Orphan Drugs Director, Drug Safety Advertising and Medical Information Specialist Director, eRegulatory Development, Global Regulatory Operations Assistant Director - ePRO Director, European Pharmacovigilance Assistant Vice President Biologics and Biotech Director, Global Pharmacovigilance and Labelling, Europe Associate Professor, Pharmaceutical Sciences Director, Global Regulatory Sciences Informatics Biomarker and Experimental Medicine Clinical Scientist Director, Informatics Business Development and Regulatory Affairs Director Director, Pharmacovigilance Quality System and Licensing Business Unit Director, Patient Management Programmes Director, Preclinical Affairs Cardiovascular Portfolio Leader, European Regulatory Affairs Director, Preclinical Safety Chair in Intellectual Property Law Director, Pre-Submission Divison, Worldwide Regulatory Affairs Chairman and CEO Director, Product Management Chief Clinical Officer and Executive VP Director, Public Private Partnerships Chief Development Officer Expert Inspector, GCP and Pharmacovigilance Chief Executive Officer Expert Pre-Clinical Advisor Chief Medical Officer Expert Statistician Chief Medical Officer and Senior Vice President Research and Development Expert, Senior Director Global Pharmacovigilance and Epidemiology Chief Scientific Officer Global Clinical Project Director Chief Statistician Global Director of Medical Information Chief Technical Officer Global EDM Manager Clinical Affairs - Director Global Head Thesaurus Management Clinical Director of Pharmacy Global Head, Cardiovascular Assessment Group Clinical eSolutions Specialist Global Head, Clinical Quality Assurance Clinical Professor, Clinical Pharmacology, Department of Pediatrics Global Head, Data Management Clinical study Support Director Global Head, Project Management Clinical Trial Manager Global Manager Clin Ops. Commercial Development Manager, European Regulatory Affairs Global Medical Director COO and Managing Director Global Medical Writing Director Corporate Affairs Manager Global Operations Business Development Manager Corporate Compliance Officer, Vice President, Global RA and QA Global Pharmacovigilance and Epidemiology - Europe Corporate Regulatory Affairs Director Global Quality Manager Corporate Vice President Drug Safety Global Regulatory Strategist Corporate Vice President Information and Biometry Global Safety Sr. Manager Data Quality Manager Head Clinical Operations Dean of Faculty Head Clinical Research and Development Department Head, Paediatrics and Medical Genetics Manager Regulatory Affairs Operations Europe Deputy Director, Industrial Relations, Regulatory Policy and Intelligence Medical and Regulatory Affairs Director Deputy Director, Pharmacovigilance Medical Director Australia and New Zealand Director and Head of Microbiology Medical Director of Clinical Research Director Drug Safety and Pharmacovigilance Medical Director, Pharmacovigilance Vaccines Director European Regulatory Affairs Post-Marketing Director Director Genomics, Office of Clinical Pharmacology, CDER President Pharmaceuticals Europe Director Global Labeling Professor Analytics and Research Director Global QA RandD / MPS Professor in Drug Safety Director Global Regulatory Affairs Professor of Clinical Pharmacology Director Global Regulatory Affairs Professor of Pediatrics and Pharmacology Director Global Safety Professor of Pharmaceutical Technology Director Logistics Solution Professor of Pharmacology/Head of Perinatal and Pediatric Director Market Access, Pricing and Reimbursement Professor, Clinical Pharmacology Director Medical and Regulatory Affairs Professor, Department of Pharmacoepidemiology Director Medical Affairs International Regional Head, Global Medical Writing Director Medicine Group, Global Drug Safety and Surveillance Regional Medical Director Director Non-clinical Statistics Submission Manager Europe Director of Clinical Quality Management Vice President Oncology Director of Corporate Strategy, Medical Communications Vice President RA and QA Director of Drug Marketing Authorization Vice President, Global Regulatory Policy and Operations Director of General Medicine Vice President, Neurosciences, Global Clinical Safety and Pharmacovigilance Director of Health Outcomes Europe Vice President, Pharmacoepidemiology Director of Legal and Regulatory Affairs VP, Clinical Quality and Compliance Director of Pharmacogenomics VP, Enterprise Solutions Director of Pharmacovigilance VP, Global Regulatory Affairs and Safety Director of Postgraduate Education VP, Nonclinical Safety Project, Safety Assessments Director of Professional Services VP, Project Management Portfolio and Planning Director of Sales Director of Standards Director of the Pharmacy Department Director Oncology and Biotechnology Therapeutic Group Director Operational Regulatory Affairs Exhibit at the EuroMeeting 2009 Director Pharmacouigilance Director Pharmacovigilance Director Pharmacy/Analytic and Inhalation Toxicology Director Project Management Showcase your company's product or service to over 3000 Director QA and Affairs Regulatory QP drug development professionals at the EuroMeeting 2009 in Director QA and Compliance Berlin. Director Regulatory and Scientific Affairs Distributor Markets EAME Director Regulatory Affairs Director Regulatory Liaison Join over 240 exhibitors to interact with professionals from Director Regulatory Policy, Intelligence and Labeling Regulatory Affairs Director Research the pharmaceutical, biotechnology, devices, government, Director Safety Management academia, healthcare delivery and related industries, from Director Strategic Regulatory Affairs Europe Director Submissions Management over 50 countries. Director, Advanced Technology Setup Director, Biometrics For further information, please contact Phyllis Suter Director, Clinical Compliance and Training Director, Clinical Development at DIA Europe: Director, Clinical Operations [email protected] or call +41 61 225 51 54 Director, Clinical Research Director, Deputy Qualified Person for Pharmacovigilance, Global Product Safety Director, Development Planning and Management Director, Discovery Biometrics 10 Director, Division of Vigilance Risk Management of Medicines NETWORKING - ALL INCLUDED IN REGISTRATION FEE

Networking Receptions, Other Opportunities Coffee and Lunch Breaks EuroMeeting attendees tell us that the • A Regulators Lunch on Monday is an essential part of the programme for networking opportunities presented by the regulators from national agencies and the EMEA. EuroMeeting are one of the key reasons for attending. Each year, the EuroMeeting offers • On Tuesday, all attendees get together for a drinks reception on the numerous opportunities to catch up with Exhibition Floor. Entertainment provided. existing contacts and to make new ones in a relaxing setting. All networking events at the • DIA’s Special Interest Area Communities (SIACs) offer a discipline-specific EuroMeeting are included in the registration fee: global community where members can share experiences and knowledge, food, beer, wine, non-alcoholic beverages and find common ground, and network with others in their fields. SIAC entertainment. activities are an integral part of the EuroMeeting and they will organise at least one networking opportunity in 2009. Jitterbug Reception Monday evening will see DIA rocking and rolling • The EuroMeeting’s Exhibition Floor, with over 250 exhibitors, is a great to a networking banquet reception at the Palais place to network. All refreshment breaks take place on the Exhibition Am Funkturm. The Palais is one of the largest Floor, so it is easy to meet colleagues and friends. and most beautiful ballrooms in Berlin and is a premiere venue for social functions. Located just • Patient Representatives are supported each year by DIA to attend the a short walk from the Convention Centre, it is EuroMeeting where attendees will have a chance to meet them and listen the perfect choice for Monday’s reception. In a to their priorities and concerns. well-preserved 1950s interior, from the gilded ceiling to the elegant staircase to the panoramic • New to the pharmaceutical industry? The EuroMeeting offers emerging bay windows, the Palais Am Funkturm cannot professionals the chance to meet in a special session. fail to impress. The theme of the reception will be the 1950s with music and dance to fit the • Over the past years, DIA Europe has increased the opportunities to attend theme. The Palais am Funkturm is beside the the EuroMeeting. There will be a specific networking programme for famous Berlin Funkturm (Radio Tower) students at the 2009 EuroMeeting in Berlin. completed in 1926.

JOIN US IN BERLIN

The City At the very heart of Europe, Berlin is a bridge between east and west and over the last few years, has evolved into a major platform for communication and knowledge transfer. Berlin is ranked first among Germany’s best conference locations and is in the international top five. Easily accessible, Berlin has three airports providing flight connections to the whole world with 91 airlines operating flights to Berlin from 157 cities in 49 countries. When in Berlin, one of the most extensive underground and regional train systems of any major city in the world as well as over 1,000 buses and trams will help you get around. If that’s not enough, over 7,000 taxi cabs will take you whenever and wherever you want to go. Berlin can boast an outstanding selection of hotels, with more than 600 available across all categories, offering the largest and most modern selection of accommodation in Europe. Nearly all the major international hotel chains are already here. Berlin is cosmopolitan and open 24 hours a day, 7 days a week. About 1,700 events every day are entertaining people from all over the world. A variety of restaurants from all different kinds of cultures and countries, as colourful and diverse as the city itself, are on offer. Every district, every street corner offers something new and exciting. One thing is certain, Berlin is always changing and it is this dynamism that gives Berlin its special appeal. Comprehensive information on a range of topics, from flying to Berlin to restaurants to beer gardens to sightseeing can be found at the tourist information website: www.visitBerlin.de

The Convention Centre

The Internationales Congress Centrum Berlin (ICC Berlin) ranks among the biggest, most advanced and most successful congress venues in the world. It was designed by architects Ralf Schüler and Ursulina Schüler-Witte. The ICC Berlin is a landmark of postwar German architecture and the model for many new congress centres all over the world. With its 80 halls and rooms seating between 20 and 9,100, its versatile facilities, superb technical installations and comprehensive range of services, ICC Berlin is the perfect choice for any convention. 11 Special Hotel Rates for your EuroMeeting 2009 Accommodation in Berlin

Hotel Name Single Room Double Room Double Room incl. Breakfast for single use incl. Breakfast incl. Breakfast

5-Star Hotels Concorde Berlin 200.00 220.00 Kempinski Bristol 190.00 215.00 Palace Berlin 195.00 195.00 215.00 Steigenberger Berlin 235.00 255.00 Intercontinental Berlin 210.00 230.00 237.00 257.00 The Westin Grand 268.00 337.00 298.00 367.00

4-Star Hotels California Hotel 135.00 150.00 Crowne Plaza Berlin City Centre 210.00 230.00 Ellington Hotel 135.00 162.00 Golden Tuilp Hotel Hamburg 150.00 180.00 Hecker’s Hotel 146.00 166.00 182.00 Hollywood Media Hotel 140.00 150.00 160.00 Maritim proArte 211.00 244.00 227.00 260.00 Melia Berlin 197.00 219.00 NH Berlin Kurfürstendamm 197.00 215.00 NH Jolly Berlin Friedrichstrasse 208.00 227.00 Novotel Tiefgarten 199.00 232.00 Park Inn Berlin 136.00 136.00 163.00 Seehof 210.00 250.00

3-Star Hotels Art’hotel Kudamm 130.00 145.00 Berlin Plaza Hotel 89.00 109.00 126.00 Concorde am Studio 95.00 115.00 Ku’damm 101 87.00 105.00 105.00 Mark Apart Hotel 110.00 130.00 Mark Hotel Berlin 110.00 140.00 Sylter Hof 90.00 112.00 134.00

2-Star Hotels Ibis Messe 99.50 129.00

Headquarter Hotels Hilton Berlin (HQ Central) 228.00 272.00 Sofitel Schweizerhof (HQ West) 200.00 220.00

DIA’s accommodation agent in Berlin, KIT, has negotiated special rates exclusively for EuroMeeting 2009 participants. To make a reservation and/or to get more information, go to www.diahome.org and click on the EuroMeeting icon.

Berlin Tours

Make the most of your stay in Berlin and meet other EuroMeeting participants by reserving a place on one of our city tours. There are four tours to choose from: two on Sunday and one on both Tuesday and Wednesday.

Sunday March 22, 2009 Morning, Orientation Tour through Berlin’s Architecture, 4 hours Afternoon, Jewish Life in Berlin, 4.5 hours

Tuesday, March 24, 2009 Afternoon, Berlin Panoramic Tour, 3 hours

Wednesday, March 25, 2009 Morning, The Government Quarter, 4 hours

For details, go to www.diahome.org and click on the EuroMeeting 2009 icon.

12 DIA Fellowships

Would you like to receive complimentary admission to the 21st Annual EuroMeeting in Berlin, March 23-25, 2009, featuring approximately 120 sessions, 350 speakers and numerous networking opportunities.

DIA Young Professionals Fellowship: Application Deadline December 1, 2008 DIA Europe welcomes the involvement of young professionals in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 young professionals in full-time employment under the age of 30.

DIA Student Fellowship: Application Deadline December 1, 2008 DIA Europe welcomes the involvement of students in the EuroMeeting and is providing complimentary admission to the EuroMeeting for 15 students in full- time education.

DIA Patient Fellowship: Application Deadline December 1, 2008 The DIA Patient Fellowship, now in its fourth successful year, is a programme to promote the participation of patients organisation representatives in the EuroMeeting. In 2008 DIA supported 22 patient representatives’ participation in the EuroMeeting by covering their complete travel and accommodation costs plus complimentary admission to the EuroMeeting in Barcelona and offered 20 additional patients representatives complimentary registration for the EuroMeeting, thus enabling a total of 42 patient representatives to actively participate in the EuroMeeting.

• Complimentary admission to conference and pre-conference tutorial of choice • Specific DIA Patient Fellowship Booth to act as a focus point to network and to distribute information • Travel costs covered • Up to 3 nights complimentary hotel accommodation provided • Patient Fellowship Reception on Sunday evening and daily briefings to encourage information and skills sharing

Fellowship Application Process: Application Packs for all three fellowships can be obtained by contacting Sandra Weber at DIA Europe: [email protected] or by calling +41 61 225 5164 or by going to www.diahome.org and clicking on the EuroMeeting icon.

2009 is a special year to be in Berlin, marking the 20th anniversary of the fall of the Berlin Wall. After "The Wall" was opened in 1989, hundreds of artists from all over the world gathered and transformed the East Side Gallery, a 1.3km-long section of the wall near the centre of Berlin in celebration and reflection of this freedom achieved. Approximately 106 paintings by artists from all over the world cover this memorial for freedom and make it the largest open air gallery in the world. With the recognition of its special connection of the past and to the present, an artists initiative was formed to preserve this "gallery" and later won Historical Monument status. To support the East Side Gallery, please visit: www.eastsidegallery.com

The image chosen for Berlin 2009 on the cover reflects the global, diverse ethos of the DIA itself. It is of a East Side Gallery mural by artist Kiddy Citny.

Kiddy Citny is a musician and fine artist, born in in 1957. He grew up in , moved to in 1977, lived in and (1979), in (1980), (1989/90), (1993/94), and also used a studio in until 2000. Citny is a famous Berlin Wall graffiti artist who began playing cat and mouse with German border guards back in 1985. His work features the themes of love and mutuality, peace and freedom, sensitivity and tenderness, willpower and responsibility. Kiddy Citny communicates complex issues with simple metaphors: "Herzgesichter" [heart-shaped faces], "Welt im Arm" [the world in your arms], "Königskinder" [royal children].

13