March 8-10, 2010Grimaldi Forum

Monaco

22ndAnnual

EUROMEET INGM o n a c o 2 0 1 0P R E L I M I N A R Y P R O G R A M M E

22nd DIA Annual EuroMeetingProgramme Committee

Theme Leaders

About the DIA EuroMeeting

The Drug Information Association’s Annual EuroMeeting is global in scope, attracting well over 3,000 professionals from over 50countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, academic research

centres, regulatory agencies and health ministries. This convergence affords attendees the opportunity to network withprofessional 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 thebroad dissemination of information on the development of new medicines or generics and biosimilars, with continuouslyimproved professional practice as the goal. The DIA is a financially independent non-profit organisation that funds itselffrom meeting and membership fees. The voluntary efforts of DIA members and speakers allow the DIA to organiseconferences, workshops and training courses and provide publications at a reasonable, competitive cost.

Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior Event Manager(EuroMeeting): dermot.ryan@diaeurope.org or call +41 61 225 5132

Cover Image: Roger Broders, “La Corne d’Or Nice Villefranche Monaco” - © 2009 ProLitterus, Zurich

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Christelle Anquez-TraxlerRegulatory and Scientific AffairsManager, AESGP, Belgium

Valdo ArneraGeneral Manager, Europe, PHTCorporation, Switzerland

Mary BakerPresident, European Federation ofNeurological Associations, UK

Patrick CelisScientific Administrator, EMEA, EU

Catarina EdfjällHead of Regulatory Affairs Europe,Celgene International SARL, Switzerland

Zaide FriasScientific Administrator,Legal/Regulatory Affairs, EMEA, EU

Trevor GibbsExecutive Vice President, ii4sm,Switzerland

Wills Hughes-WilsonSenior Director, Health Policy Europe,Genzyme, Belgium

Jackie HunterSenior Vice President, ScienceEnvironment Development,GlaxoSmithKline, UK

Brenton JamesConsultant in Strategic RegulatoryAffairs in the European Union, UK

Angelika JoosDirector, Regulatory Policy Europe,Merck Sharp & Dohme (Europe) Inc.,Belgium

Craig JohnsonPrincipal Regulatory Scientist,Regulatory Information & ExternalAffairs, Eli Lilly, UK

Thomas KühlerDirector of Operations, MPA, Sweden

Pierre-Yves LasticSenior Director, Data Privacy &Healthcare Interoperability Standards,sanofi-aventis, France

Hubert LeufkensProfessor, Division ofPharmacoepidemiology andPharmacotherapy, Utrecht Institute forPharmaceutical Studies,The Netherlands

Damian O’ConnellExecutive Director, Clinical R&D, PfizerLtd., UK

Marisa Papaluca AmatiDeputy Head of Sector, Safety andEfficacy of Medicines, EMEA, EU

Tomas SalmonsonVice Chair CHMP, MPA, Sweden

Gabriele SchwarzHead, GCP Inspection Services, BfArM,Germany

Thomas SeverinHead Paediatrics, Novartis Pharma AG,Switzerland

Nick SykesDirector, Head, Global RegulatoryIntelligence and TA Analysis, Pfizer, UK

Geoff TuckerEmeritus Professor of ClinicalPharmacology, University of Sheffield,and Chairman of Simcyp Ltd., UK

Beat WidlerGlobal Head, Clinical Quality Assurance,F. Hoffmann-La Roche AG, Switzerland

Dear Colleague,

It is our pleasure to invite you to participate in three days of discussion,sharing of experience, moving the debate forward and networking atthe 22nd Annual EuroMeeting in Monaco, March 8-10, 2010. Whetheryour involvement will be as a session chair, speaker, tutorial instructor,or attendee, and whether you are a representative of a regulatoryagency, from academia, industry or a patient group, or a student oryoung professional, we believe you can play a key role in building thesuccess of the EuroMeeting and ensuring its place as one of the mostimportant European conferences for professionals involved in thedevelopment of medicines.

When deciding on the themes, we have chosen the integrated, multi-disciplinaryapproach, aiming to generate interest from as many disciplines as possible. We hopewe have identified interesting and thought-provoking topics for the themes. Withthis approach we wish to create a lively platform for a debate on developmentand market access of medicines in Europe.

Being aware that many of you will be keen to look for your specific area ofinterest in the programme, as the programme is developed we willhighlight clearly on the EuroMeeting website and in the advanceprogramme which sessions will discuss, for example, non-clinical aspects,statistics, etc.

Monaco is an exciting location, well-known to most people. Despitebeing a small country, it has a lot to offer and is very hospitable andculturally interesting. No doubt there are numerous challenges aroundbut we strongly believe you should not miss this opportunity to bringyour contribution to the debate on drug development. Make your plansto come to Monaco next year!

Bruno Flamion and Kerstin Franzén

Kerstin FranzénSenior Director, Regulatory Policy & Intelligence,Pfizer, Sweden

Kerstin Franzén has a background in Regulatory Affairs covering 29 years.

After an academic degree at Uppsala University, M Pharm Sci, she joined the

pharmaceutical industry, first for a short period in the marketing area, and

then went into the regulatory arena. The first seven years were spent with the

Roche affiliate in Sweden, followed by a move to the Swiss headquarters

where she stayed for four years, still in Regulatory Affairs. In 1990 she decided

to join Kabi Pharmacia and go back to Sweden. This company went through

a number of mergers and acquisitions, which eventually led to her current

position with Pfizer in Regulatory Policy & Intelligence, an area she has been

involved in since 1998.

Bruno Flamion

Professor, Clinical Pharmacology, University of Namur, Belgium

and Chair, CHMP, Scientific Advice Working Party, EMEA

Bruno Flamion is an MD who practised internal medicine and nephrology in

Belgium. He was a Research Fellow at the NIH (1988-1992) and with the

Belgian National Fund for Scientific Research (1992-1996) and later got a PhD

in physiological sciences from the University of Brussels. He is now Full

Professor of Physiology and Pharmacology at the University of Namur,

Belgium, where he heads a molecular physiology lab. He has been involved as

a medical expert for the Belgian Federal Agency for Medicines and Health

Products (FAMHP) since 1999 and for the EMEA: CHMP, PK group,

Pharmacogenomics, and more recently CAT (Committee for Advanced

Therapies). His favourite activity is chairing the Scientific Advice Working Party.

Welcome from the EuroMeeting 2010 Co-Chairs Bruno Flamion and Kerstin Franzén

Daniel Brasseur

EMEA PDCO, Federal Agency for Medicines and

Medicinal Products, Belgium

Emmanuel Chantelot

Executive Manager, European Biopharmaceutical

Enterprises, Belgium

Daan Crommelin

Scientific Director, Top Institute Pharma,

The Netherlands

Hans-Georg Eichler

Senior Medical Officer, EMEA, EU

Julianne Hull

Senior Director, Global Development Data

Operations, Wyeth Research, UK

Tim Kievits

CEO, PamGene, Chair of EuropaBio Personalised

Medicines Working Group, The Netherlands

José Ramet

Professor, University of Antwerp, Chairman,

Paediatric Department, University Hospital

Antwerp and Queen Paola Children’s Hospital,

Belgium

Malcolm Rowland

Emeritus Professor, School of Pharmacy and

Pharmaceutical Sciences University of

Manchester, England

Agnès Saint Raymond

Head of Sector, Scientific Advice, Paediatrics and

Orphan Drugs, EMEA, EU

Christian Schneider

Acting Head, Division EU Cooperation/

Microbiology, Paul-Ehrlich-Institut, Germany,

and Chair, CHMP, Biosimilars Working Party

Beatriz Silva Lima

CHMP and SAWP Member, SWP Chair; Professor,

Pharmacology, University of Lisbon, INFARMED,

Portugal

Susie Stephens

Principal Research Scientist, Eli Lilly and Company,

USA

Wolfgang Summa

Executive Vice President, Business Development,

OmniComm Systems, Germany

Erik Tambuyzer

Senior Vice President, Corporate Affairs, Europe

and International, Genzyme, Belgium

Catherine Tuleu

Senior Lecturer and Deputy Director, The School

of Pharmacy, University of London, UK

Programme Advisors

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Theme 1InnovationJackie Hunter, Senior Vice President, Science Environment Development,GlaxoSmithKline, UKDamian O’Connell, Executive Director, Clinical R&D, Pfizer Ltd., UK

Theme OverviewNew medicines development is going to require innovation at all stages of thedrug discovery and development process. The challenges that companies facein bringing medicines to the market, in ways that are both time and costeffective, are huge. These challenges are driving new ways of working bothwithin companies, between companies and between academia and industry.The Innovative Medicines Initiative is a public/private partnership that will drivepre-competitive data sharing and new ways of working between industry andacademia. Open innovation has produced demonstrable benefits for otherindustries – could it do the same for pharma? The theme will examine wherethe boundaries might lie for both pre-competitive data sharing and openinnovation. New clinical designs and methodologies are being employed bothfor clinical trials and experimental medicine studies and some of theseapproaches will be discussed. Finally some examples of innovation intranslational medicine and preclinical studies will be described.

Proposed Sessions1. The Innovative Medicines Initiative2. Is an open innovation paradigm the way forward for pharma?3. The importance of pre-competitive data sharing to accelerate drug

development4. What is an innovative medicine?5. Innovation in early and late phase clinical trials I6. Innovation in early and late phase clinical trials II7. Have the benefits of translational medicine been realised?8. Innovative preclinical research underpinning drug discovery and

development

Theme 2Staying in Business: How to Make Sure you Comply WithAll Rules and RegulationsBeat Widler, Global Head, Clinical Quality Assurance,F. Hoffmann-La Roche AG, SwitzerlandGabriele Schwarz, Head, GCP Inspection Services, BfArM, Germany

Theme OverviewIn the EU, the Pharmaceutical Package and in other countries other new rulesand regulations have created new obligations. Also advocacy groups, the publicand the media – the scientific as well as the general press – are also becomingmore active and demanding. This makes the development of new medicinesmore and more demanding, not only from a clinical and scientific perspectivebut also from a process and regulatory aspect.

Globalisation is, for instance, seen by some as progress as patients in developingcountries are getting access to innovative medicines through earlier involvementin clinical trials and because of a strengthening of local economies throughimproved healthcare systems. Others are fearful that there is a shift in the focusof clinical development from industrialised countries to Asia and Latin Americaand thus depriving investigators in these “traditional” regions of access toclinical trials, and that trials in developing countries are a new form ofcolonialism and results in the exploitation of vulnerable populations. Thecounterargument to this is a not uncommon topic in the debate aboutdevelopment: protection of patients in developing countries by well-intentionedand often self-nominated advocates from the so-called industrialised countriesis nothing else than paternalism. Two sessions will look at this conflict and givebackground information about patients, the healthcare system and risks andbenefits when conducting clinical trials in India and Latin America. In this contextthe expectations of the public for transparency do not come as a surprise and

will be the topic of another session. Misuse of medicines and counterfeiting areother facets of globalisation and closely linked to the widespread use of theinternet. A session will review the so far rather neglected topic of misuse oftherapeutic agents in doping. Doping would not be made so easy withoutmanufacturing capacities in countries with weaker regulatory controls and e-commerce, and this leads to another session about counterfeiting. Newregulations and mounting pressure are also an opportunity for smarter strategiesand the use of “intel-ligence” for study management and quality oversight:progress of the CTTI imitative, innovative approaches to quality riskmanagement that makes extensive use of computerised processes, and in themanagement of partners will be the focus of three sessions.

Proposed Sessions1. Transparency: A Pandora’s box or a panacea?2. The price of globalisation: Is industry indeed exploiting Indian patients?

What should we all know about Indian society, medical practice andpatients?

3. The price of globalisation: The costs, benefits, risks and pitfalls whenmoving development and manufacturing to Latin America

4. Counterfeiting: Who owns the problem? Who is in control?5. Misuse of medicines and doping: What is the problem? How big is the

problem?6. Quality Risk Management: Myth, promise or a solution to the

operational challenges of clinical development and regulatorycompliance

7. CTTI (Clinical Trial Transformation Initiative): What has been achieved?Has it already delivered on the expectations raised?

8. Governance challenges when managing partners such as CROs andlicensing partners

9. Managing the end of lifecycle of a medicinal product

Theme 3Paediatric Medicines – Did the Regulation Deliver on itsPromises?Angelika Joos, Director, Regulatory Policy Europe, Merck Sharp & Dohme(Europe) Inc., BelgiumThomas Severin, Head Paediatrics, Novartis Pharma AG, Switzerland

Theme OverviewThis theme will reflect on the opportunities and current challenges of paediatricdrug development. The new paediatric legislation was established in Europeover three years ago and some early stocktaking can already be made: Theimpact of the new framework is multi-dimensional and touches on manyaspects of new product development and lifecycle management. Regulators andIndustry are discussing the adequate implementation of the new requirementsand are negotiating Paediatric Investigation Plans. The overall goal is to meet theneeds of children in many therapeutic areas whilst delivering the best possiblesafety protection for the population. Researchers and Industry are collaboratingto set up the necessary infrastructure to conduct numerous paediatric studieswithin a global R&D scope. They define new uniform standards as well as clinicaland non-clinical methodologies to overcome the various challenges in theunique paediatric environment. Better and more innovative paediatricformulations are needed to address the selective preferences of children andenable good compliance with a treatment for optimal outcomes. Involvement ofpatent attorneys and lawyers is recommended for the development of a strategyto claim and achieve the deserved benefits in compensation for undertaking theadditional research investments. A preliminary assessment of the positive impacton public health in balance with required resources will be made.

Proposed Sessions1. Regulatory challenges and experience with new paediatric requirements2. Focusing on pharmacovigilance and safety aspects of paediatric trials3. Design and conduct of ethical paediatric clinical programs4. Paediatric Development - Is a global strategy achievable?

2010 Themes and Theme Leaders

5. Paediatric formulations: Will they reach the market?6. Harmonised regulatory expectations for juvenile animal testing?7. Challenges for obtaining the rewards8. Initial impact of the Paediatric Regulation after three years

Theme 4Decision Making - The Key to Efficient and EffectiveDrug Development, Approval and AccessCraig Johnson, Principal Regulatory Scientist, Regulatory Information &External Affairs, Eli Lilly, UKTomas Salmonson, Vice Chair CHMP, MPA, Sweden

Theme OverviewEffective “decision making” is essential for innovative medicinal products to bemade available to patients. During the last decade, new stakeholders haveemerged who are influencing which product may finally be taken by anindividual patient. Company strategies, regulatory approvals, assessments byHTA bodies, international and national treatment recommendations, local drugcommittees, opinion leaders, treating physicians and, in the end, the (informed)patient may influence choice of treatment. Decision making by all thesestakeholders is complex and subjective by nature. Regulatory bodies strive tomake their assessment of the benefit/risk of a new product a valuable tool forother parties, not least of which are the increasingly prominent HTA bodies.However, this aim, while laudable from an efficiency point of view, can only befully achieved by building trust through adequate and appropriate transparency.Hence, there needs to be a description of the decision making clear enough toallow the reader to agree or disagree with the decision, and to understand theapplicability of that decision in the context of their own decision making.Correspondingly, this increasingly complex environment demands thatpharmaceutical companies make critical decisions on the most efficient andeffective drug development programme to meet both regulatory and HTAneeds. The aims of this theme are to examine these elements and consider theways in which decision-making processes may need to change in response.Ways to approach benefit/risk decisions and increased transparency in thisprocess will be discussed both from an industry and regulatory/healthcareprovider aspect. Various specific aspects of pre- and post-approval decisions willbe debated.

Proposed Sessions1. Patient influence on regulatory decisions: How much do they and should

they have?2. Should regulatory processes become more transparent and, if so, how?3. Conditional approvals: How to strike the right balance between early

access, patient safety and commercial reality?4. Clinical trials: The demise of traditional surrogate markers? How to create

new markers?5. The true value of risk management for decision making and for post-

approval commitments6. Evolving the benefit/risk concept and the use of quantitative models:

Where are we now and where are we going?7. Influence of HTA on regulatory decision making: Reality? An opportunity?

A threat?8. Company decision making during drug development

Theme 5Paving the Way for Advanced Therapies - Fostering NewGenerations of Biotechnology-Derived MedicinesCatarina Edfjäll, Head of Regulatory Affairs Europe, Celgene InternationalSARL, SwitzerlandPatrick Celis, Scientific Administrator, EMEA, EU

Theme OverviewFrom recombinant therapeutic proteins and monoclonal antibodies, to advancedtherapies like cell-based and gene therapy medicinal products, each newgeneration of biotechnology-derived medicines comes with great opportunitiesand interesting challenges. In Europe, the Advanced Therapies (ATMP)legislation was implemented in December 2008 and it has brought a newCommittee for Advanced Therapies (CAT) and novel regulatory procedures foradvanced therapies to the EMEA. Additionally, biosimilars have been evaluatedand regulated in Europe for a few years now, as several biosimilar recombinanttherapeutic proteins have been approved and are being commercialised inEurope.

This theme will address the opportunities and challenges raised by today’sinnovative breakthroughs using new biotechnology platforms and noveltreatment approaches. It will specifically discuss how the evolving regulatoryenvironment impacts on companies working in this cutting-edge research areaand on regulators performing the assessment of such products, whichsometimes come with highly specific requirements. The experience in the firstyear of the ATMP legislation and the CAT will be reported, as we get closer toseeing new advanced therapies available to patients. Specific case studies andexamples will be shared. Borderline areas in the legislation around medicaldevices and combination products will also be examined.

Biotechnology-derived medicines have opened and will continue to open uphuge treatment opportunities for patients, and we need to understand if thecomplexity of new generation medicinal products could impact theresponsibilities of healthcare professionals and requirements for riskmanagement plans.

Proposed Sessions1. CAT Experience in the first year2. ATMP borderlines3. ATMPs and biotherapeutics – Do they require changes to established

quality and manufacturing concepts?4. Impact of new therapies on preclinical research5. Clinical research: New therapies - new challenges6. Biosimilars - A reality check7. Advanced therapies and medical devices - Living with a new risk

management reality?8. Health Technology Assessments - Are they possible for advanced therapies?

Theme 6Challenges for Switching Centrally Authorised Productsfrom Prescription to Non-Prescription StatusChristelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP,BelgiumZaide Frias, Scientific Administrator, Legal/Regulatory Affairs, EMEA, EU

Theme OverviewWith Regulation (EC) No. 726/2004, the centralised procedure became a newroute for the change of legal status of medicines hence allowing their access asa non-prescription medicine across the EU at once. This is breaking new groundsfor industry, the EMEA and national authorities and generating newopportunities but also challenges and question marks. Taking the views ofregulators, industry, healthcare professionals and patients/consumers, thistheme will reflect on both the experience accumulated so far and on futuretrends. The impact on national markets and national attitudes will also be animportant and interesting question for debate. Ensuring that thepatients/consumers get the right level of information is paramount in the self-care context and this may bring new questions and challenges when discussedat EU level. Last, will the centralised procedure give a new chance to well-established molecules and/or its combinations? Ultimately, will the centralisedprocedure, coupled with incentives and better regulation principles, contributeto boost the competitiveness of the European self-care sector?

2010 Themes and Theme Leaders

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Proposed Sessions1. ‘Central switches’ - Where are we going?2. Switching trends: Evolution or revolution?3. Could the UK model be reproduced at EU level?4. Impact of EU decision on non-prescription status at the national level5. Information to patients/consumers: Fit for purpose?6. New chance for well-known substances: CP vs. MRP/DCP7. Are the incentives provided in the legislation sufficient to boost innovation

at EU level?8. Is a Risk Management Plan supportive of innovative switches?

Theme 7Personalised MedicineWills Hughes-Wilson, Senior Director, Health Policy Europe,Genzyme, BelgiumMarisa Papaluca Amati, Deputy Head of Sector, Safety and Efficacy ofMedicines, EMEA, EU

Theme OverviewPersonalised Medicines is an increasingly “hot topic” – but whether it is seen asa threat, an opportunity or the very essence of the future (bio)pharmaceuticalindustry depends largely on who you are talking to. This theme will outline whatpersonalised medicine and targeted therapies mean in reality and will explorehow the field can be developed to its full potential. Several regulatory agencieshave taken steps to address the emerging possibilities to target therapies eitherduring or after development, to reduce side-effects and increase effectiveness.Where we go from here and what happens next will largely determine if thisfield develops or remains a complicated niche. This theme will build onexperience to date, learning from the existing diagnostic and therapyrelationships. It will examine regulators’ points of view from differentgeographic locations and explore the attitudes of other stakeholders in thehealthcare field, be they patients, industry, payers or physicians. It will explorewhat steps need to be taken to achieve a successful marketing authorisation fora diagnostic-and-drug combination and what needs to be done to support andencourage the fields that will be crucial to the success or otherwise of this field,including diagnostics and IT systems. And finally, participants will discuss howwe will handle the data that is gathered, what intellectual property and privacyissues might be created and how can we address them? Representatives fromall aspects of the growing and inter-disciplinary personalised medicines field willparticipate in this theme, with the objective of advancing the debate andbringing clarity in where we stand and where we need to go from here.

Proposed Sessions1. Personalised medicines: What is it, where do we stand and where are we

going?2. One medicine does not fit all. And one business model does not fit all.

Which business models have worked and what can we learn?3. Is Europe adapted to personalised medicines? What needs to change?4. DNA Sampling - A logistical and organisational challenge or impossible

hurdle?5. Evidence and study designs in Personalised Medicines6. Evidence and study designs in Personalised Medicines in a post-authorisation

setting7. International regulatory frameworks in the field of personalised medicine –

converging or diverging?8. Diagnostics - If this is such a crucial element of the whole field, what are

we doing to support, encourage and protect the diagnostics field?

Theme 8Taking the European Regulatory Infrastructure ForwardBrenton James, Consultant in Strategic Regulatory Affairs in the EuropeanUnion, UKThomas Kühler, Director of Operations, MPA, Sweden

Theme OverviewThis theme will address many issues concerning the procedure of gainingregulatory approval and market access for medicinal products in Europe. TheEuropean Commission has set out both a communication and several legislativeproposals on patient information, counterfeit medicines and pharmacovigilance.This is draft legislation that will go via the co-decision procedure through theCouncil and the European Parliament. The European Medicines Agency ischanging to be able to handle the additional responsibilities of AdvancedTherapies and the changing nature of the types of marketing applications thatare being filed in the Centralised Procedure. As the CHMP plays a pivotal roleat the European Medicines Agency, its role and objectives will be described anda survey of all applications in 2008 will provide key learning points for thedevelopment of medicinal products. The European Medicines Agency sets outits strategic vision in the publication of Roadmaps.. The success of the Roadmapup to 2010 and the map for the next five years will give an understanding of thedirection the Agency will follow. As a complement to the Agency's Roadmaps,the Heads of Agencies released their Strategy Paper setting out the ambition forNational Competent Authorities in the future. Stakeholders are interested in theresources that are available to support the Decentralised and MutualRecognition Procedure and how they will be allocated. Industry sees much togain in a dialogue with regulators. Ways that dialogue may be enhanced to thebenefit of both industry and Agencies will be explored so that creativesuggestions can be offered for further discussion. Recognising that the approvalof a marketing application is the first step to the availability to patients of amedicine, the vital role and contribution of Health Technology Assessmentbodies will be presented so that the interaction between the two organisationscan be understood by stakeholders. Europe is one of the three majorpharmaceutical markets in the world and co-operation between regulatoryagencies in these countries and others are important for public health.

Proposed Sessions1. The Pharmaceutical Package - The latest information2. The European Medicines Agency and its committees3. CHMP: Its role and objective for 20104. The European Medicines Agency and the Roadmaps5. Achievements of the Heads of Agencies6. Industry and regulators dialogue7. Agencies and health technology assessment bodies8. International co-operation with regulatory agencies

Theme 9Risk ManagementTrevor Gibbs, Executive Vice President, ii4sm, Switzerland

Theme OverviewRisk management remains a topic on everyone’s agenda. We will reflect on theimplementation of regulations by the EMEA and FDA over the last few years,describe some of the major research initiatives in the area and provide practicalworking examples from industry and regulators. Above all, the theme will reflectthe multi-disciplinary approach that is required to create a clear picture of whatwe know, what we don’t know and how to address harm minimisation andbenefit maximisation for patients and customers.

Proposed Sessions1. Regulatory developments in risk management in the EU and US2. Special requirements for the safety of biologicals3. Performance, quality control and audit in pharmacovigilance and risk

management

2010 Themes and Theme Leaders

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4. Non-clinical support to aid risk management5. Risk management - but what about the benefit?6. Observational and clinical data sets? Weight of evidence7. Risk management for switch products8. Research initiatives in risk management

Theme 10The Informed PatientNick Sykes, Director, Head, Global Regulatory Intelligence and TA Analysis,Pfizer, UKMary Baker, President, European Federation of NeurologicalAssociations, UK

Theme OverviewAn overview and discussion on the use and provision of information onmedicinal products to and by patients covering the following areas:

• The use of information by patients: Will having more information enablepatients to provide an increasingly meaningful contribution to themanagement of their healthcare? What contribution to healthcare systems canknowledgeable patients make?

• An exploration of the information on medicines that is available to patientsand information that is wanted by patients focussing on: the impact onpatients with the availability (or lack thereof) of information on medicinalproducts; an analysis of what information patients would like and in what formvs. the information 'holders'/producers are willing to give against the backdropof what information can legally be provided to patients; can patients fullyunderstand the information currently available to meet their healthcare needs?

• A discussion on whether all access points for information are utilised to thebest effect: the internet is not the nirvana – ‘traditional’ methods for providinginformation are still important; the pros and cons of centralised access pointsand greatly dispersed access points; how can all stakeholders ensure consistentcommunication across states, languages and cultures to facilitate a commonunderstanding

Proposed Sessions 1. The Pharmaceutical Package: Information to patients proposals – what

difference will they make?2. Communication of information on medicinal products (1) – how can a

balance be achieved between legal restrictions and patient expectations?3. Communication of information on medicinal products (2) – factors to

consider to ensure optimum accessibility and understanding4. Patient use of information on medicinal products5. What information do patients want on medicinal products and how far do

the current provisions go to meet these needs?6. How involved can informed patients be in the development and

commercialisation of medicines ?7. Patient involvement in regulatory decision making8. Are informed patients cost-effective? How to ensure that patients

understand the decisions being made on their medicines

Theme 11eHealthValdo Arnera, General Manager, Europe, PHT Corporation, SwitzerlandPierre-Yves Lastic, Senior Director, Data Privacy & Healthcare InteroperabilityStandards, sanofi-aventis, France

Theme OverviewThe influence of technology on Healthcare and Clinical Development has seenan unprecedented growth in the recent years. The theme intends to cover thecontribution these technologies have made and will continue to make; whetherthey have been used for a while, like EDC or ePRO, or are still emerging, liketools to improve drug safety. We will also consider technologies that will shapethe way drugs will be developed and patients will be treated in the future.

Proposed Sessions1. The new IT Architecture for meeting the challenges of eHealth2. ePRO Use and Validation3. EDC Case Studies4. Emerging technologies for optimisation of patient treatment5. Improving drug safety through the use of new technologies6. Healthcare interoperability standards7. Utilisation of electronic medical records in clinical development8. Connecting healthcare and clinical research

Theme 12Pharmaceutical Sciences in 2020Geoff Tucker, Emeritus Professor of Clinical Pharmacology, University ofSheffield, and Chairman of Simcyp Ltd., UKHubert Leufkens, Professor, Division of Pharmacoepidemiology andPharmacotherapy, Utrecht Institute for Pharmaceutical Studies, TheNetherlands

Theme OverviewThe pharmaceutical sciences are likely to look very different in 10 years time.These sessions will peer into the crystal ball with respect to changes in researchemphasis, enabling technology, paradigms for drug development, evaluationand regulation and the education of the workforce.

Proposed Sessions1. What major research activities will drive drug discovery and development?2. What will the enabling technologies be?3. What paradigm/geographical shifts will there be in drug

discovery/development?4. How will regulators reconcile the need for rapid market access with the

assessment of benefit/risk?5. How will changes in education meet the demands of industry and

regulation?

2010 Themes and Theme Leaders

Confirmed Session Chairs

John Balian, Vice President, WorldwideHead Clinical Safety & Risk Management,Pfizer Inc., USA

Lyle Bootman, Dean & Professor,University of Arizona, USA

Matthias Bündte, Principal, Booz AllenHamilton AG, Switzerland

Emmanuel Chantelot, ExecutiveManager, European BiopharmaceuticalEnterprises, Belgium

Hubertus Cranz, Director-General,AESGP, Belgium

Daan Crommelin, Scientific Director, TopInstitute Pharma, The Netherlands

Shirish Dattatraya Sherlekar, PracticeHead, Life Sciences, Tata ConsultancyServices, Ltd, India

Sergio Guerrero, Director,OCAHospital/Monterrey Intl Research Center,Mexico

Julianne Hull, Senior Director, GlobalDevelopment Data Operations, WyethResearch, UK

Pierre-Yves Lastic, Senior Director, DataPrivacy & Healthcare InteroperabilityStandards, sanofi-aventis, France

Alex Leugger, DRA Manager, F.Hoffmann-La Roche AG, Switzerland

Hubert Leufkens, Professor Division ofPharmacoepidemiology &Pharmacotherapy, Utrecht Institute forPharmaceutical Studies, The Netherlands

Janis Little, Senior Director, DevelopmentQuality & Compliance, Genentech Inc.,USA

Carolin Miltenburger, Director HEOR, i3Innovus, Germany

Olivier RabinScience Director, WADA, Canada

Andrew Rut, Vice President, GlobalClinical Safety and Pharmacovigilance,GlaxoSmithKline, UK

Christian Schneider, Acting Head,Division EU Cooperation/Microbiology,Paul-Ehrlich-Institut, Germany, and Chair,CHMP, Biosimilars Working Party

Beatriz Silva Lima, CHMP and SAWPMember, SWP Chair; Professor,Pharmacology, University of Lisbon,INFARMED, Portugal

Burkhard Sträter, Lawyer, Kanzlei Sträter,Germany

Wolfgang Summa, Executive VicePresident, Business Development,OmniComm Systems, Germany

Panos Tsintis, Medical Director, ChoicePharma, UK

Geoff Tucker, Emeritus Professor ofClinical Pharmacology, University ofSheffield and UK Chairman, Simcyp Ltd.,UK

John Weiler, President, ComplewareCorporation, USA

Phil Wilcox, Vice President, WorldwideNon-Clinical Safety Projects,GlaxoSmithKline, UK

Call for Student Poster Abstracts:Full-time university students, residents and fellows are invited to submit abstracts

for the Student Poster Session which will take place on Tuesday, March 9, 2010 at

the EuroMeeting in Monaco.

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 Monaco, 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 2010 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 6, 2009. 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 11, 2009

Call for Professional Poster Abstracts:A maximum of 40 abstracts from full-time professionals will be selected for the professional poster presentations to be held on Tuesday, March 9, 2010.

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 6, 2009. 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 11, 2009

If you require further information about Student or Professional Posters,

please contact Maureen McGahan at DIA Europe:

maureen.mcgahan@diaeurope.org

Call for StudentPoster Abstracts:Deadline:Friday, November 6, 2009

Call for ProfessionalPoster Abstracts:Deadline:Friday, November 6, 2009

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Student and Professional Posters

Would you like to receive complimentary admission to the 22nd Annual EuroMeetingin Monaco, March 8-10, 2010, featuring approximately 120 sessions, 350 speakersand numerous networking opportunities?

DIA Young Professional Fellowship: Application Deadline Friday, November 6, 2009

DIA Europe welcomes the involvement of young professionals in the EuroMeeting and isproviding complimentary admission to the EuroMeeting for 15 young professionals in full-

time employment under the age of 30.

DIA Student Fellowship: Application Deadline Friday, November 6, 2009

DIA Europe welcomes the involvement of students in the EuroMeeting and is providing complimentaryadmission to the EuroMeeting for 15 students in full-time education.

DIA Patient Fellowship: Application Deadline Friday, November 6, 2009The DIA Patient Fellowship, now in its fifth successful year, is a programme to promote the participation of patients’ organisation representatives in theEuroMeeting. In 2009 DIA supported 22 patient representatives’ participation in the EuroMeeting by covering their complete travel and accommodation costsplus complimentary admission to the EuroMeeting and offered 20 additional patients representative’s complimentary registration for the EuroMeeting, thusenabling a total of 42 patient representatives to participate in the EuroMeeting.

• Complimentary admission to conference• Specific DIA Patient Fellowship Booth to act as a focus point to network and to distribute information• Travel costs covered• Complimentary hotel accommodation provided• Targetted networking opportunities

Fellowship Application Process: To download an application form, please go to www.diahome.org and click on the EuroMeeting icon. If you have any questions, please contact MaureenMcGahan at DIA Europe: maureen.mcgahan@diaeurope.org

DIA EuroMeeting Fellowships 2010

Networking Events All Included in your Registration Rate!

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Monday Mediterranean Reception Join us at the Fairmont Hotel on Monday evening for a networking banquet reception. Located in the heart of the Principality of Monaco betweenthe Mediterranean Sea and the legendary Casino of Monte Carlo, it will provide the perfect opportunity to network with other conferenceparticipants in a relaxing environment with a backdrop of views of the Mediterranean Sea.

Other Networking Opportunities:

• On Tuesday, all attendees get together for a drinks reception on the Exhibition Floor at the Grimaldi Forum Convention Centre.

• Speed Networking Sessions

• Knowledge Cafés

• 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.

• 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.

• 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.

• New to the pharmaceutical industry? The EuroMeeting offers young professionals a specific networking programme which includes a special

session, a guidance programme with experienced professionals and a networking reception.

Networking Receptions, Coffee and Lunch BreaksEuroMeeting attendees tell us that the networking opportunities presented by the EuroMeeting are one of the key

reasons for attending. Each year, the EuroMeeting offers numerous opportunities to catch up with existing contacts andto make new ones in a relaxing setting. All networking events at the EuroMeeting are included in the registration fee:

food, beer, wine, non-alcoholic beverages and entertainment.

DIA Fellowships Networking Events

The Principality of Monaco may be one of the smallest countries inthe world but it has an incredible amount to offer. Accessible,glamourous, and with DIA’s specially negotiated hotel rates, veryaffordable, Monaco is one of the world’s most attractivedestinations. For three days in March 2010, Monaco’s 33,000inhabitants will be joined by 3,000 EuroMeeting participants. Asall hotels are within walking distance of the Convention Centre,the 2010 EuroMeeting will have an intimate feel that maximisesnetworking opportunities. With picturesque places to discover,sites to visit, museums, leisure facilities, shops and boutiques,and over 150 restaurants, you may be very tempted to extendyour trip.

An international hub, easily accessible by air, road and rail, theNice-Côte d’Azur International Airport is a 30-minute drive away,

providing flights to more than 80 destinations throughout theworld, and the new TGV railway centre is completely underground

and links the town centre to the whole European rail network.

Quick facts:Area: Approximately 2 square km (1 square mile)

Location: Between the French and Italian RivierasClimate: Sunny weather all-year round

Languages: The official language of Monaco is French but English, Italian, as well asMonégasque (local language) are also spoken.

Currency: the EuroGovernment: Constitutional monarchy. The Grimaldi family has ruled over Monaco since 1297.

Discovering Monaco

La Condamine is the port area. Monte Carlo is the main centre for business and entertainment where thefamous Monte Carlo Casino is located. Monaco-Ville, the old city built on a rocky promontory extending intothe Mediterranean, known as the Rock of Monaco, or simply Le Rocher (the Rock) is where the palace islocated. For more information, please go to www.visitmonaco.com

The Convention Centre

The EuroMeeting will take place at the state-of-the-art Grimaldi Forum on the waterfront. This daylight-filled buildingwith its stunning glass entrance is built on land reclaimed from the sea. It opened for conferences in September2000.

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Exhibit at theEuroMeeting 2010

Showcase your company’sproduct or service to over3,000 drug developmentprofessionals at theEuroMeeting 2010 in Monaco.

Join over 200 exhibitors to interact with professionals from thepharmaceutical, biotechnology, devices, government, academia,healthcare delivery and related industries, from over 50countries.

For further information, please contact Phyllis Suter at the DrugInformation Association in Europe:phyllis.suter@diaeurope.org or call +41 61 225 5154

Join us in Monaco: Welcome to the EuroMeeting 2010 Global Village

Getting to MonacoBy roadThe European motorway network which passes only 8km from the centre of town links the Principality toFrance, Spain, Italy, Switzerland, Germany, the Benelux countries, Austria and the UK. On leaving Nice airport,this network enables you to reach the Principality of Monaco, 22km away in less than 30 minutes, thanks toits own junction on one of the departmental coastal roads.

Between Nice and Monaco, you can also take three highly attractive roads, the “Basse Corniche” (N98), alongthe coast, the “Moyenne Corniche” (N7), passing through Eze Village and the “Grande Corniche”, passingthrough La Turbie and Col d’Eze at an altitude of 512m.

By railAll trains stop at the Monaco/Monte Carlo station. The TGVs to and from Paris (journey time 5.5 hours). Trains to Milan, Genoa or Basel during the day.Overnight trains to Strasbourg, Paris, Toulouse, Irun, Port-Bou, Milan, Venice, Pisa and Rome. Regional Express Trains which connect the towns on the Côted’Azur.

By planeThe Nice Côte d’Azur International Airport links the Principality of Monaco to more than 86 worldwide destinations. The highlight of the Côte d’Azur, thePrincipality of Monaco, via Nice airport (25 minutes by road, or 6 minutes by helicopter transfer) is linked daily to major European capitals and beyond to allcontinents.

Bus from Nice Côte d’Azur International Airport to MonacoDIA will provide a complimentary direct shuttle between Nice Côte d’Azur International Airport and DIA’s conference hotels in Monaco.

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Special Hotel Rates for your EuroMeeting 2010Accommodation in Monaco

Monaco - Surprisingly Affordable Hotel Rates!Monaco hotels are ranked as some of the best in the world. DIA has negotiated special conference rates which are very competitive in comparison to manyother major cities in Europe. All rates include breakfast, service and all taxes. Double and single room rates are the same.

Rooms can be reserved via the EuroMeeting 2010 website from July 6, 2009.

Please be advised that DIA has only one contracted and exclusive hotel agent for the EuroMeeting 2010: 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.

Hotel Name Room Rate incl. breakfast Distance from hotel to Convention Centreand complimentary DIA airport shuttle to hotel

4 Star Palace

Hôtel de Paris 265.00 € Walking distance

Hôtel Metropole Monte-Carlo 270.00 € Walking distance

4 Star Deluxe

Hôtel Hermitage 209.00 € Walking distance

Fairmont Monte-Carlo 203.00 € Walking distance

Port Palace 213.00 € Walking distance

Le Méridien Beach Plaza 203.00 € Walking distance

Monte-Carlo Beach Hotel 199.00 € Walking distance

Monte-Carlo Bay Hotel 199.00 € Walking distance

3 Star Deluxe

Columbus Monaco 203.00 € 10 minutes by bus (complimentary hotel shuttle to

the Convention Centre in the morning and evening)

3 Star

Hotel Ambassador 170.00 € 5-10 minutes by bus

Novotel Monte-Carlo 185.00 € Walking distance

Book your hotel room through the EuroMeeting website and you

may have a good reason to come back in May! The Grimaldi

Forum Convention Centre, in partnership with the Monaco

Convention Bureau, is offering you the chance to win the

fantastic and exclusive prize of two tickets in their Monaco Grand

Prix VIP private stand, including a welcome cocktail and lunch, if

you book your hotel room through the EuroMeeting website by

December 4, 2009 (17:00 CET). All conference participants who

have booked their room by that date will be automatically entered

into the draw.

Book your hotel room by

December 4, 2009

and get the chance to win two VIP

tickets for the Monaco Formula One Grand Prix

(Sunday, May 24, 2010)

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Have you seen the EuroMeeting 2010 website? Simply go to www.diahome.org and click on the EuroMeeting icon.

You will be able to:

• Register for the meeting

• Get information on being an exhibitor

• Find out more about student and youngprofessional activities

• Submit a student poster or professionalposter

• Take advantage of specially-negotiatedaffordable hotel rates in Monaco

• Learn more about Monaco

• Get more information about networkingopportunities

• Search for sessions and speakers

DIA has created a group on the social networking site, LinkedIn:

DIA 22nd Annual EuroMeeting, March 8-10, 2010,Monaco

• 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

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

• Latest news on the conference programme and confirmed speakers

• Updates on the conference networking events, hotels, travel and transport information

Visit www.linkedin.com > search groups > DIA 22nd Annual EuroMeeting

Registration isnow open!