BUILD YOUR OWN CONFERENCE!

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1 2ND ANNUAL CLINICAL FORUM L JUBLJANA 2008 BUILD YOUR OWN CONFERENCE! DATA DRIVEN DRUG DEVELOPMENT DECISIONS OCTOBER 20-23, 2008 EXHIBITION & CONVENTION CENTRE LJUBLJANA, SLOVENIA

2 DATA DRIVEN DRUG DEVELOPMENT DECISIONS Dear Participants, In its second year after a very successful first event in 2007, the DIA Clinical Forum will again provide broad learning, discussion and networking opportunities for clinical operations professionals. This time, clinical data will be in the focus of numerous tutorials, sessions and cross-functional workshops. New and experienced colleagues in the field of clinical and safety Data Management, Statistics, Medical Information, Pharmacovigilance, Information Technology and Validation will be able to attend a wide range of educational forums and discuss experiences and solutions. Besides established formats like tutorials and sessions dedicated to the different areas of interest, cross-functional workshops looking at a particular operations topic from different angles will provide the opportunity to meet colleagues from business partner functions to discuss new ideas, interfaces and data streams. We very much look forward to meeting you in Ljubljana. Jens Reinhold Head of Non-Interventional Studies Bayer Schering Pharma AG, Germany Programme Chairperson Jens Reinhold Head of Non-Interventional Studies, Bayer Schering Pharma AG, Germany Programme Committee Valdo Arnera General Manager Europe, PHT Corporation, Switzerland Joris Cauquil Consultant, Head of Training, Head of Quality Assurance, AMITIS/Effi-Stat, France Janet Davies Medical Information Director, Gilead, UK Brian Edwards Director, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK Eva Hammarström-Wickens Biostatistics & Data Management Programme Leader Urology & Oncology Manager, In- and Outsourcing, Orion Pharma, UK Jullianne Hull Senior Director, Global Development Data Operations, Wyeth Research, UK Steven Julious Senior Lecturer, Medical Statistics Group, University of Sheffield, UK Ingrid Klingmann President, Pharmaplex bvba, Belgium Pierre-Yves Lastic Senior Director, Standards Management & Data Privacy, sanofi-aventis, France Nick Lucas Vice President Global Data Management, INC Research, UK Breffni Martin Director, CanReg Ltd., Ireland Stéphane Marzabal Manager, Data Management, Merck Serono International SA, Switzerland Bryan McDowell Clinical Trial Head, Dermatology, Gastroenterology, Urology Therapeutic Area, Novartis Pharma AG, Switzerland Detlef Nehrdich Director Statistics, Data Management & EDC Project Office Europe, Abbott GmbH & Co KG, Germany Olaf Schoepke Managing Director, Extedo Ltd., UK WHO WILL ATTEND Professionals at all levels in the following disciplines: Clinical Data Management Statistics eclinical IT Clinical Research Medical Information & Communications Clinical Safety & Pharmacovigilance Validation Clinical Operations 2 DIA Europe 2008

3 SESSION FINDER Use the helpful session finder below to search for sessions relevant to your professional interest areas. Clinical Data Management / eclinical Monday, October 20, 2008 Tutorial: 1, 2, 3, 4, 5, 6, 7, 8 Tuesday, October 21, 2008 Session 1: Regulatory Session 1: PASS Session 1: Adaptive Trials Session 1: Computer Systems Validation Session 2: Efficacy Tools in Clinical Trials Session 2: Optimising Processes Session 2: Validation of EDC/eClinical Session 3: Standards/CDISC Session 3: Validation of epro Session 4: Signal Detection II Session 4: The Clinical Site / Inspections Session 4: Data Integration Session 4: Validation of other Clinical Systems Wednesday, October 22, 2008 Session 5: Optimisation of Safety Data Handling Session 5: Operations Role Evolution Session 5: Quality Management Session 5: Systems Security and Access Control Session 6: Efficiency of Investigator Meetings Session 6: PRO/ePRO I Plenary Debate Session Session 8: Outsourcing Session 8: PRO/ePRO II Thursday, October 23, 2008 The Participants Day - Workshops Clinical Research / Clinical Operations Monday, October 20, 2008 Tutorial: 2, 3, 4, 5, 6, 7, 8 Tuesday, October 21, 2008 Session 1: Regulatory Session 1: PASS Session 1: Adaptive Trials Session 1: Adaptive Dose Finding Studies Session 1: Regulations Update Session 2: Efficacy Tools in Clinical Trials Session 2: Site Management Session 2: Optimising Processes Session 3: Signal Detection I Session 3: Studies in Asia Session 3: Health Economics Session 3: Writing Skills Session 4: Signal Detection II Session 4: The Clinical Site / Inspections Session 4: 10 Years of ICH E9 Wednesday, October 22, 2008 Session 5: Optimisation of Safety Data Handling Session 5: Operations Role Evolution Session 6: Phase I Session 6: Efficiency of Investigator Meetings Session 6: PRO/ePRO I Plenary Debate Session Session 8: Paediatric Session 8: Outsourcing Session 8: PRO/ePRO II Thursday, October 23, 2008 The Participants Day - Workshops Clinical Safety & Pharmacovigilance Monday, October 20, 2008 Tutorial: 1, 2, 3, 5, 8 Tuesday, October 21, 2008 Session 1: Regulatory Session 1: PASS Session 2: Efficacy Tools in Clinical Trials Session 2: Optimising Processes Session 3: Signal Detection I Session 3: Standards/CDISC Session 4: Signal Detection II Session 4: Validation of other Clinical Systems Session 4: 10 Years of ICH E9 Session 4: Interface with Pharmacovigilance Wednesday, October 22, 2008 Session 5: Optimisation of Safety Data Handling Session 6: PRO/ePRO I Plenary Debate Session Session 8: PRO/ePRO II Thursday, October 23, 2008 The Participants Day - Workshops IT / Validation Medical Information & Communications Statistics Monday, October 20, 2008 Tutorial: 1, 2, 3, 4, 6, 7, 8 Tuesday, October 21, 2008 Session 1: Regulatory Session 1: Computer Systems Validation Session 2: Efficacy Tools in Clinical Trials Session 2: Optimising Processes Session 2: Validation of EDC/eClinical Session 3: Standards/CDISC Session 3: Validation of epro Session 3: Quality Management Session 4: Signal Detection II Session 4: The Clinical Site / Inspections Session 4: Data Integration Session 4: Validation of other Clinical Systems Session 4: Interface with Pharmacovigilance Wednesday, October 22, 2008 Session 5: Optimisation of Safety Data Handling Session 5: Quality Management Session 5: Systems Security and Access Control Session 6: Phase I Session 6: Efficiency of Investigator Meetings Session 6: PRO/ePRO I Session 6: Audits and Inspections Plenary Debate Session Session 8: Outsourcing Session 8: PRO/ePRO II Session 8: Website Technology Thursday, October 23, 2008 The Participants Day - Workshops Monday, October 20, 2008 Tutorial: 2, 3, 8 Pre-session 1: Current Issues in European MI Pre-session 2: MI in Central and Eastern Europe Tuesday, October 21, 2008 Session 1: Regulatory Session 1: Regulations Update Session 2: Site Management Session 2: Resource Management Session 2: Liasing with External Stakeholders Session 3: Quality Management Session 3: Writing Skills Session 4: Interface with Pharmacovigilance Wednesday, October 22, 2008 Session 5: Working with Internal Partners Session 6: Compliance Session 6: Field Medical Plenary Debate Session Session 8: Website Technology Thursday, October 23, 2008 The Participants Day - Workshops Monday, October 20, 2008 Tutorial: 1, 2, 3, 8 Pre-session 1: Surrogate Endpoints Pre-session 2: Using Re-Sampling in Clinical Trials Tuesday, October 21, 2008 Session 1: Regulatory Session 1: PASS Session 1: Adaptive Dose Finding Studies Session 2: Challenges in Early Phase Trials Session 3: Signal Detection I Session 3: Standards/CDISC Session 3: Health Economics Session 4: 10 Years of ICH E9 Wednesday, October 22, 2008 Session 5: Bayesian Methods Session 6: PRO/ePRO I Session 6: Multiple Endpoints Plenary Debate Session Session 8: PRO/ePRO II Thursday, October 23, 2008 The Participants Day - Workshops 3

4 CLINICAL FORUM 2008 Monday October 20, 2008 Half-day Tutorials 09:00-12:30 14:00-17:30 Tuesday October 21, 2008 Session 1 Session 2 Session 3 Session 4 09:00-10:30 11:00-12:30 14:00-15:30 16:00-17:30 Tutorial 1: CDISC Tutorial 4: Preparing Study Sites for Audit and Inspection of Electronic Source Data and Computerised Systems Regulatory Evolving Efficacy Tools in Clinical Trials Signal Detection I Signal Detection II Tutorial 2: Data Privacy in Clinical Trials and Pharmacovigilance Tutorial 5: Annual Safety Reports Current and Future Challenges Tutorial 6: Electronic Source Documents Used in Clinical Trials PASS, Present and Future Site Management Studies in Asia The Clinical Site - Collaboration, Support and Inspections Tutorial 7: EDC & epro Best Practices Adaptive Trials - Implication on Operations Optimising Processes Utilising Technology Standards/ CDISC Data Integration Tutorial 3: The EU Qualified Person for Pharmacovigilance - Exploring the Role and Sharing Current Experience Tutorial 8: FDA Computer Systems Validation Validation of EDC/eClinical Validation of epro Validation of other Clinical Systems Pre-session 1 Pre-session 2 14:00-15:30 16:00-17:30 Session 1 Session 2 Session 3 Session 4 09:00-10:30 11:00-12:30 14:00-15:30 16:00-17:30 Surrogate Endpoints Using Re-Sampling in Clinical Trials Adaptive Dose Finding Studies Challenges in Early Phase Trials Health Economics 10 Years of ICH E9 Current Issues in European Medical Information Medical Information in Central and Eastern Europe Regulations Update Resource Management Liasing with External Stakeholders Quality Management Writing Skills Interface with PV Tutorials Plenary Session 2nd Clinical Forum Programme Chairperson: Jens Reinhold IT/Validation Co-Chairs: Olaf Schoepke Breffni Martin Medical Information & Communications Statistical Methodology in Clinical R&D Workshops Chair: Janet Davies Co-Chairs: Joris Cauquil Stephen Julious 4

5 AT A GLANCE Wednesday October 22, 2008 Session 5 Session 6 Plenary Session Session 8 09:00-10:30 11:00-12:30 14:00-15:30 16:00-17:30 Thursday October 23, 2008 Workshops 09:00-15:00 Optimisation of Safety Data Handling Operations Role Evolution Quality Management Systems Security and Access Control Phase I Efficiency of Investigator Meetings PRO/ePRO I Audits and Inspections PLENARY SESSION Welcome Address Jens Reinhold, Clinical Forum Chairperson 2008, Head of Non-Interventional Studies, Bayer Schering Pharma AG, Germany Brigitte Franke-Bray, Director DIA Europe, Switzerland "This House Believes that 90% of all Data Collected is Rubbish" Julianne Hull, Senior Director, Global Development Data Operations, Wyeth Research, UK Four brave debaters will present their arguments on the topic of data collection during clinical trials and the value it does or does not add. Prof. Andrew P. Grieve, Statisitician, Division of Health & Social Care Research, Department of Public Health Sciences, School of Medicine, King's College, UK Dr. Jane Barrett, The Barrett Consultancy, Consultant in Pharmaceutical Medicine, Medico- Legal Affairs and Medical Ethics, UK Session 5 Session 6 Session 8 09:00-10:30 11:00-12:30 Dr. Nick Lucas, Vice President, Global Data Management, INC Research, UK Mr. Joris Cauquil, Consultant, Head of Training, Head of Quality Assurance, AMITIS/Effi-Stat, France 16:00-17:30 Bayesian Methods Working with Internal Partners Multiple Endpoints Compliance Field Medical will explore all aspects of process, quality, timelines, volume and ultimately the value added by data collected during the running of clinical trials. The audience will have the opportunity to vote at the beginning and at the end of the debate, listen to seasoned professionals provide arguments for both sides and to ask questions of the debaters. These debates are designed to be entertaining and result in interesting facets of topics being aired in a safe way. Paediatric Outsourcing - from Tactical to Partnerships PRO/ePRO II Website Technology for Communications THE PARTICIPANTS DAY - LEARNING FOR YOURSELF AND FROM OTHERS On Thursday, conference attendees have the great opportunity to participate in a number of workshops. The workshops will provide expert knowledge from patients, regulators, physicians and industry specialists. An important key component of the workshops will be that participants are asked to share their opinions and experiences thus learning from each other. Topics on offer are: personalised medicine, including real life success stories and how technology may enable ethical aspects of studies, the changing landscape and growing role for non-interventional studies both locally and globally, personal education, training and development. Last, but not least, there will be events designed for your own personal development, showing how to manage international teams and how to cope with extreme workload situations avoiding personal and team member burnout. We look forward to this forum which is created specifically for the conference participants needs. You are cordially invited to join the lively discussions. CDM, eclinical Research, Clinical Safety & Pharmacovigilance, Clinical Operations Co-Chairs CDM: Julianne Hull Pierre-Yves Lastic Nick Lucas Stéphane Marzatal Detlef Nehrdich Chair Clinical Research: Ingrid Klingmann CDM, eclinical Research, Clinical Safety & Pharmacovigilance, Clinical Operations Chair Clinical Safety & Pharmacovigilance Brian Edwards Co-Chairs eclinical Valdo Arnera Eva Hammarström-Wickens Bryan McDowell 5

6 Monday, October 20, 2008 TUTORIAL 1 09:00-12:30 CDISC TUTORIAL 2 09:00-12:30 DATA PRIVACY IN CLINICAL TRIALS AND PHARMACOVIGILANCE This tutorial is currently in development. Please visit > click on the Clinical Forum icon for regular programme updates. Co-Instructors Pierre-Yves Lastic, Senior Director, Standards Management & Data Privacy, sanofi-aventis, France Anne Bahr, R&D France Data Privacy Coordinator, sanofi-aventis, France Overview The exponential growth of information technology in the health sector as well as the globalisation of work and data flows is raising concerns that the privacy of individuals involved in clinical trials and pharmacovigilance activities may be breached, with negative impacts on these individuals life. In order to face this challenge, Data Protection Authorities around the world are raising the privacy bar through new regulations or a stricter interpretation of existing ones. Additionally, other actors like Ethics Committees or Institutional Review Boards are requesting ever more safeguards to protect the privacy of study patients. Finally, different interpretations of the same rules in different countries make the life of clinical trial and data managers ever more difficult. This tutorial is aimed at improving the understanding of worldwide data privacy principles and regulations, as well as how to comply with them. 08:00-09:00 Tutorial Registration 09:00-12:30 Tutorial 1: CDISC TUTORIALS 09:00-12:30 Tutorial 2: DATA PRIVACY IN CLINICAL TRIALS AND PHARMACOVIGILANCE 09:00-12:30 Tutorial 3: THE EU QUALIFIED PERSON FOR PHARMACOVIGILANCE - EXPLORING THE ROLE AND SHARING CURRENT EXPERIENCE Morning Coffee will be served from 10:30-11:00 Lunch for Tutorial participants will be served from 12:30-14:00 12:30-14:00 Tutorial Registration 14:00-17:30 Tutorial 4: PREPARING STUDY SITES FOR AUDIT AND INSPECTION OF ELECTRONIC SOURCE DATA AND COMPUTERISED SYSTEMS Learning Objectives At the end of this tutorial participants should be able to: Understand the principles of Personal Data Protection in the European Union Understand the differences between European, US and Asian Data Privacy regulations Have a basic knowledge on how to comply with European and other worldwide regulations Tutorial Overview: Why is Personal Data Protection important? Principles of Personal Data Protection, based on the European Regulations Overview of worldwide regulations and the differences between them Specific regulations for biomedical research and pharmacovigilance and their consequences How to comply? Information & consent Communication & training IT security & validation Legal instruments (contracts, Safe Harbor, BCRs) Data Privacy organisation Target Audience: All individuals involved in the organisation and management of clinical trials and pharmacovigilance, or handling with data collected to perform these activities. 14:00-17:30 Tutorial 5: ANNUAL SAFETY REPORTS - CURRENT AND FUTURE CHALLENGES 14:00-17:30 Tutorial 6: ELECTRONIC SOURCE AND DOCUMENTS USED IN CLINICAL TRIALS 14:00-17:30 Tutorial 7: EDC & epro BEST PRACTICES 14:00-17:30 Tutorial 8: FDA Afternoon Coffee will be served from 15:30-16:00 REGISTRATION: Please indicate on the registration form which tutorial(s) you would like to attend. FEE: Fee for each tutorial is

7 Monday, October 20, 2008 TUTORIAL 3 09:00-12:30 THE EU QUALIFIED PERSON FOR PHARMACOVIGILANCE - EXPLORING THE ROLE AND SHARING CURRENT EXPERIENCE Instructor Brian Edwards, Director, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK Overview The EU qualified person for pharmacovigilance (QPPV) is accountable to the European authorities for ensuring that their company's Pharmacovigilance system is adequate to meet the legal and regulatory requirements described in EU legislation. This role is expected to have a global public health focus that the role will need to have significant influence on decisions pertaining to drug safety in the organisation, including the US. Recent European legislation as well as Volume 9A requires all marketing authorisation holders to have one qualified person for pharmacovigilance (QPPV) with responsibility for establishing and maintaining all aspects of the company s global pharmacovigilance system. Although acknowledged to be a vital function, there is little practical guidance on how QP responsibilities should best be conducted, while maintaining compliance with regulatory requirements. The jurisdiction of the QPPV stretches to wherever there is an active license for a product authorised in the EU. Thus the role in many companies has a global impact. During this tutorial we will discuss and advise on current practice to help address issues such as: What does being qualified mean in practice for the QPPV and the organisation What are appropriate contractual obligations and job description to cover points such as 24 hour availability, workload, personal indemnity, delegation and adequate back up How QPPV activities should be documented to allow adequate quality assurance How inspectors and regulatory authorities regard the EU QPPV role and expectations for involvement in the entire PV system How to make the QPPV role work in practice using examples from both large and small companies, including CROs How to optimise interactions between the company as a whole and the QPPV to obtain adequate mutual oversight and support What should be QPPV input into post-authorisation commitments and risk management plans How should the interface between the QPPV and quality function work in practice How the QPPV function relates to national nominated individuals for safety The speakers will also update the audience about whether there should be an appropriate forum to allow QPPVs across the industry to interact and share best practice to the mutual benefit of both public health and industry alike. Learning Objectives At the end of this tutorial participants should be able to: Explain legal, regulatory and business implications surrounding the QPPV function to permit effective implementation of this role Define what would be reasonable expectations to have about the QPPV Understand the different approaches taken by other companies Have gained better insight into the expectations of regulators and inspectors Target Audience Professionals in companies who will shortly be setting up pharmacovigilance operations in Europe or with experience in post-marketing clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Medical product safety assessment Data analysis Epidemiology Labeling Quality assurance/quality control Compliance Qualified persons for pharmacovigilance (QPPV) Deputy QPPVs Contract research organisations and consultants TUTORIAL 4 14:00-17:30 PREPARING STUDY SITES FOR AUDIT AND INSPECTION OF ELECTRONIC SOURCE DATA AND COMPUTERISED SYSTEMS Instructor Teri E. Stokes, Director, GXP International, USA Overview What sponsor and site systems are used in your studies? Are you confident that they will all pass a QA audit or regulatory inspection? How can you show documented evidence for the trustworthiness of the source data in your trial? Come to this tutorial for a practical approach and tools to use to answer yes to these questions. Computerised systems and electronic data are now a major component in every clinical trial and study site. They often include interactive voice response systems (IVRS) to randomise patient treatment and manage study supplies, electronic patient records, electronic case record forms (ecrfs) and patient diaries (ediaries) to record study data, and the many diagnostic and laboratory analyses performed by computerised systems. The May 2007 Guidance from FDA on Computerised Systems Used in Clinical Investigations (CSUCI) includes in its scope sponsors, contract research organisations (CROs), data management centers, clinical investigators, and institutional review boards (IRBs). Site systems used for patient histories, laboratory analysis, and the creation or hosting of other source data in a trial can now come under FDA inspection with these guidance concepts in mind. This tutorial provides practical tips and tools for how to prepare your study sites to host such an inspection of the systems used in your trial. It also describes the ways and means for establishing an auditable electronic archive for study data at the site. Technology discussions will be strictly from a GCP end user view and will not require technical expertise. Learning Objective At the end of this tutorial participants should be able to: Apply the tools provided for hosting a site audit or inspection Document the system used in a study to support the trustworthiness of its source data Set up an auditable electonic archive for study records CME - This session will teach site personnel including physicians and nurses how to meet regulatory requirements for the trustworthiness of source data in a trial when it is generated by or stored on a computer system. Target Audience Clinical operations and data management professionals Site qualifiers and study monitors Clinical QA auditors Inspectors Principle investigators Study nurses and site coordinators Sponsor, CRO, and study site IT professionals deploying study systems 7

8 Monday, October 20, 2008 TUTORIAL 5 14:00-17:30 ANNUAL SAFETY REPORTS - CURRENT AND FUTURE CHALLENGES TUTORIAL 6 14:00-17:30 ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS Co-Instructors Véronique Basch, Head of Drug Safety, HPM SA Geneva, Switzerland Brian Edwards, Director, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK Overview The contents, structure and aim of the Annual Safety Reports (ASRs) will be discussed, taking into account the safety profile of a drug throughout its life cycle. The preparation of a scientifically sound ASR depends on the input, collaboration and expertise of different departments. Therefore, the operations and procedures for ASR preparation are of paramount importance. The required content of Annual Safety Reports (ASRs) is outlined by European Commission guidance, CT 3. This guideline does not provide any template or detailed instructions on how the document should be prepared, thereby leaving plenty of room for interpretation. The ASR, however, should not only focus on summarising and commenting on the serious adverse reactions from line listings and summary tabulations. The ASR has a much broader scope and should consider all relevant findings, including those from non-clinical studies, which may affect patients enrolled in a specific trial or the benefit-risk evaluation of the drug development programme. A flexible ASR template structured to include and evaluate all relevant safety findings will be proposed. The discussion on the template will take into account CIOMS VII and highlight the links between ASRs, PSURs, RMPs and benefitrisk analysis (If ICH E2F is in step 2 at the time of the presentation, it will also be taken into account). Since the understanding and development of the safety profile of a drug starts at the pre-clinical stage and continues throughout its life cycle (as pointed out by CIOMS VII), the owner of the ASR should be the Drug Safety Department. This would allow drug safety personnel to better identify, understand and assess potential and identified risks once the drug is on the market. The preparation of a scientifically sound ASR by the Drug Safety Department requires the input and collaboration of many other departments, such as discovery, pharmacology, pre-clinical and clinical. Therefore ASR operational and procedural aspects are of extreme importance and should be agreed upon by all stakeholders before starting to write this document. Instructor Pierre-Yves Lastic, Senior Director, Standards Management & Data Privacy, sanofi-aventis, France Overview During the past two decades clinical trial sponsors have been slowly moving from the paper to the electronic world. One of the reasons for the very low speed of adoption of new technologies in this area has been the fear that regulatory authorities may not accept electronic source documents as equivalent to paper documents. A recent EMEA guidance may help to bring some light in this complex area. This tutorial will cover the following topics: Basic requirements for electronic source documents, based on ICH, FDA, EMEA & CDISC guidelines Status of current regulations in Europe and the USA Review of the requirements for electronic source documents for different technologies Learning Objectives At the end of this tutorial participants should be able to: Understand the basic requirements for the acceptability of electronic documents as a reliable source of information Understand the current position of regulatory authorities in Europe and the USA Know which technologies can be used today under which conditions Target Audience Clinical trial managers Clinical data managers IT specialists Quality assurance staff Learning objectives At the end of this tutorial participants should be able to: Describe the ASR contents and objectives and to learn how to present them in a structured manner Understand that the ASR operational challenges require a thorough planning and to recognise which procedures and workflows should be in place before writing this document Target Audience Clinical Clinical data management Pharmacovigilance & drug safety Medical writing Regulatory affairs Clinical R&D Good clinical practices Project management 8

9 Monday, October 20, 2008 TUTORIAL 7 14:00-17:30 EDC & epro BEST PRACTICES TUTORIAL 8 14:00-17:30 FDA Co-Instructors Bryan McDowell, Clinical Trial Head, Dermatology, Gastroenterology, Urology Therapeutic Area, Novartis Pharma AG, Switzerland Jonathan Andrus, Vice President, Data Management and Regulatory Operations, SCDM and Phoenix Data Systems Inc., USA Overview Electronic Data Capture (EDC) and Electronic Patient Reported Outcomes (epro) tools are routinely used in hundreds of clinical trials each day. More sponsors are choosing EDC and epro as either an alternative or a complement to paper-based clinical Trials. Co-Instructors Armando Oliva, Deputy Director, Bioinformatics, Office of Critical Path Programs, OC, FDA, USA Stephen E. Wilson, Director, Division of Biometrics III, CDER, FDA, USA This tutorial is currently in development. Please visit > click on the Clinical Forum icon for regular programme updates. The session will be structured as an interactive tutorial that will look at the many aspects of EDC and epro that are particularly important from a data management viewpoint. From an interactive standpoint, tutorial participants will be provided with case studies that they will be asked to explore together in groups. The intention of these case studies is to help the participant better understand and apply best practice techniques using a real world case study. EDC and epro will be explored in terms of data management activities pertinent during the Study Start, Conduct, and Study Closeout Phases of a clinical trial. In particular: Deployment considerations Data integration of EDC and non-edc sources SOP considerations Planning for the unplanned How to prepare your organisation to execute a trial in EDC and epro Training considerations Managing change in EDC and epro studies Partnering with clinical research to get the most efficiency during data cleanup and lock from using EDC and epro Data archival considerations Learning Objectives At the end of this tutorial participants should be able to: Understand best practices related to the implementation, management and close out of EDC and epro studies Understand how to apply some of these best practices through interactive group exercises Be better prepared to effectively manage technology based clinical trials Target Audience All individuals involved in the organisation and management of clinical trials. This includes, but is not limited to: Clinical project managers Clinical data managers Clinical quality assurance professionals. 9

10 CLINICAL FORUM 2008 EXHIBITION DIA Europe would like to invite you to showcase your company's products and services at our 2nd Annual Clinical Forum which will be held in Ljubljana, the capital of Slovenia, from October 20-23, The Conference incorporates almost 20 years of industry-renowned DIA European CDM Conferences, as well as many years of groundbreaking DIA European eclinical, Clinical Research, Validation and IT Conferences. In 2008, after a very successful first event in 2007 which attracted 700+ delegates from over 20 countries, the DIA Clinical Forum will again provide a broad learning, discussion and networking opportunity for clinical research professionals. The Conference has now been expanded to include clinical and safety data management, clinical research and clinical operations, statistics, medical information, pharmacovigilance, information technology and validation. Looking at a particular operations topic from different angles will provide the opportunity for delegates to meet colleagues from business partner functions to discuss new ideas, interfaces and data streams. Your company's presence at this truly global conference will provide an ideal opportunity to reach your target audience! The Clinical Forum 2008 Exhibition will run from Tuesday, October 21 until Thursday, October 23. At any one time, 4-7 parallel sessions will be taking place and this year the Plenary will be held on Wednesday afternoon to encourage delegates to attend the conference on all three days. EXHIBITING COMPANIES AS OF JUNE 25, 2008 Company AEPODIA SA C3i, Inc. Cardinal Health Research Services CDISC ClinPhone Entimo AG eresearchtechnology i3 Statprobe Medidata Solutions Online Business Applications, Inc. PharmaForms GmbH Phase Forward PHT SGS Life Sciences Services XClinical GmbH Country Belgium USA USA USA UK Germany USA USA USA USA Germany UK USA France Germany 10

11 Showcase your products and services to more than 700 key decision makers - all in the one place, at the one time! The Clinical Forum 2008 Exhibition will feature the innovations below, to ensure an optimal networking environment for exhibitors and delegates: All delegates must enter and exit via the exhibition area to reach all facilities and sessions. Delegate refreshments will be served inside the exhibition hall during all breaks and before sessions. Exhibition hours will be adjusted to reflect this. Catering, coffee stations, seating and tables will be situated around the exhibition hall to further encourage the flow of delegate traffic. Attendee, Speaker and Exhibitor Registration Desks, the Information Desks and the DIA Booth will be situated in the exhibition hall. The Meeting Point will be located in the exhibition hall. Relaxation areas will be situated around the exhibition hall. The close proximity between the session rooms and the exhibition area will allow delegates sufficient break time to explore the exhibition floor. Networking events will be held in the exhibition hall on both Tuesday and Wednesday evenings. The Clinical Forum 2008 Exhibition opening hours: Tuesday, October 21, 2008, from 7:30-18:30 There will be a networking reception from 17:30-18:30 in the exhibition hall and a networking dinner in a nearby restaurant from 19:00-21:00 Wednesday, October 22, 2008, from 8:00-18:30 There will be a networking reception from 17:30-18:30 in the exhibition hall Thursday, October 23, 2008, from 8:00-14:00 Over the past years, the exhibit hall has reached full capacity early. Booth space is sold on a first-come, first-served basis. The fee is EUR , including 20% Slovenian VAT, for a 3x3m space, standard electrical supply, a table, two chairs, one fullmeeting registration (which allows access to all scientific sessions) and up to two exhibit booth personnel registrations. Sign up now to assure the space of your choice. Download an application form today at > Click on the Clinical Forum icon > Exhibits For demographic information on the senior level professionals that attended last year's Clinical Forum, or for further information, please contact Phyllis Suter, DIA Europe Exhibits Manager, on or phyllis.suter@diaeurope.org 11

12 Monday, October 20, :30- WELCOME COFFEE AND 14:00 REGISTRATION STATISTICS 14:00-15:30 Pre-session 1 SURROGATE ENDPOINTS IN DRUG DEVELOPMENT AND APPROVAL: ISSUES AND OPPORTUNITIES Kevin J. Carroll, Chief Statistician, AstraZeneca, UK Drug development is not getting any easier. Development times, costs and regulatory demands for ever more data continue to increase. Surrogate endpoints (and biomarkers) may offer opportunities to shorten development times and bring important, new and effective medicines to patients and physicians sooner than otherwise might be the case. However, many issues remain. Despite there being many accepted surrogate endpoints, the use and validation of new surrogates remains both difficult and controversial, especially in terms of substituting for conventional clinical endpoints in pivotal trials to support drug approval. The aim of the session is to review the issues and opportunities for the use of surrogate endpoints in drug development. Industry and regulatory views will be provided. Biomarkers to Aid Decision Making in Early Drug Development Glen Clack, Clinical Development Director, Discovery Medicines, AstaZeneca, UK The Need for and Place of Surrogate Endpoints in Drug Development Simon Day, Statistical Expert, Roche Products Ltd., UK Qualification of Biomarkers and Surrogates by CHMP/SAWP Kristina Larsson, Scientific Administrador, EMEA, EU MEDICAL INFORMATION & COMMUNICATIONS Testing hypotheses and assessing uncertainty are the focus of most statistical data analyses. In clinical trials, where settings may be complicated and the samples may have small to moderate sizes, asymptotic methods are not always satisfactory or even tractable. Re-sampling methods may offer a valid alternative that performs equally well or better. This is illustrated in three contexts typical in clinical trials with new drugs. Accuracy Bands for Curves Using Re-Sampling in Clinical Trials Gerard Derzko, Statistician, sanofi-aventis R&D, France Bootstrap Methods for Dose Response or Concentration Response Problems Guenter Heimann, Global Head Biostatistics ED, Novartis Pharma AG, Switzerland Using Bootstrap Tests in a Combined Superiority and Non-Inferiority Approach to Multiple Endpoints Pascale Tubert-Bitter, Director, Research Department, INSERM U780, France MEDICAL INFORMATION & COMMUNICATIONS 16:00-17:30 Pre-session 2 MEDICAL INFORMATION IN CENTRAL AND EASTERN EUROPE Alexander Bedenkov, Head of Medical Affairs, Schering-Plough Central East AG, Ukraine and CIS This session will include presentations from a variety of perspectives on the practice of Medical Information within countries in Central and Eastern Europe. The integration of Central and Eastern European countries into broader European or Global Medical Information activities will be discussed. Russian Model for Medical Information Natalia Kakitelashvili, General Director, Almedis, Russia Integrating CEE With EU and Global Medical Information Jin Vermaat, Medical Affairs Europe, Centocor B.V., The Netherlands 14:00-15:30 Pre-session 1 CURRENT ISSUES IN EUROPEAN MEDICAL INFORMATION Janet Davies, Medical Information Director, Gilead, UK This session will provide an update on current issues relating to Medical Information in Europe. This will include the results of a recent survey of the Medical Information function across Europe. Key Issues Relating to Medical Information in Europe Janet Davies, Medical Information Director, Gilead, UK Results of European Medical Information Survey Sharon Leighton, Consultant, Sharon Leighton Consultancy, UK 15:30-16:00 COFFEE BREAK STATISTICS 16:00-17:30 Pre-session 2 USING RE-SAMPLING IN CLINICAL TRIALS Gerard Derzko, Statistician, sanofi-aventis R&D, France Tuesday, October 21, :30- WELCOME COFFEE AND 09:00 REGISTRATION CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 09:00-10:30 Session 1 REGULATORY SESSION Pierre-Yves Lastic, Senior Director, Standards Management & Data Privacy, sanofi-aventis, France Data Standards and the Future of Clinical Study Data Submissions to FDA Armando Oliva, Deputy Director, Bioinformatics, Office of Critical Path Programs, OC, FDA, USA Additional confirmed speakers are: Stephen E. Wilson, Director, Division of Biometrics III, CDER, FDA, USA David Verbraska, Vice President, Global Head, Worldwide Regulatory Policy & Intelligence, WRAQA, Pfizer Inc., USA 12

13 09:00-10:30 Session 1 PASS: POST AUTHORISATION SAFETY STUDIES Gary Coward, Senior Director and Strategic Consultant, Peri-Approval Clinical Excellence, PAREXEL International, UK In January 2007, an update on the guidance for Post Authorisation Safety Studies was issued in Chapter 7 of Volume 9A of the Rules Governing Medicinal Products in the European Union. Although the updated chapter clarifies some of the ambiguities of the previous version, there are still questions around definition, categorisation and scope that are the subject of much debate. This session reviews the current guidance and industry best practice as well as sharing experience of some of the practical challenges of designing and implementing a non-interventional PASS as part of a post-authorisation commitment programme, thereby opening up the debate as to how to increase Market Authorisation Holders confidence and compliance to this guidance. Risk Management Plan to Patient Recruitment; Facing the Challenges of Implementing a Post Authorisation Study Study Janine Collins, Head of Risk Management, Celgene International, Switzerland 09:00-10:30 Session 1 ADAPTIVE TRIALS - IMPLICATION ON OPERATIONS Bryan McDowell, Clinical Trial Head, Dermatology, Gastroenterology, Urology Therapeutic Area, Novartis Pharma AG, Switzerland The advent of innovative adaptive trial designs has provided a much welcomed opportunity to improve the effectiveness of drug development and shorten the submission timelines. However, enthusiasm for such designs must be coupled with a realistic assessment of the present ability to implement them with integrity. This session will focus on the challenges of implementing a successful adaptive trial along with discussing the logistical and operational considerations of flexible trial designs. The Operational Implications of Using Dynamic Randomisation Methods to Conduct Adaptive Trials Andrew James O'Callaghan, Solutions Architect, Medidata Solutions, UK Implementation of Adaptive Design Clinical Trial - The Vendor s Perspective Sheila Rocchio, Vice President, PHT Corporation, USA Great Adaptations: A Novel Approach to Clinical Trial Design Graham J. Nicholls, Product Manager, ClinPhone plc, UK IT/VALIDATION 09:00-10:30 Session 1 COMPUTER SYSTEMS VALIDATION Breffni Martin, Director, CanReg Ltd., Ireland Computer validation requirements and perceptions have been on something of a rollercoaster in recent times. This session will cover practical down to earth approaches to computer validation and will specifically cover risk-based approaches Executing a Successful Validation Programme Incorporating Risk Chris Frost, Solutions Consultant, Qumas Ltd., Ireland Best Practices in Computer System Validation Result of a Survey Kjeld Wetlesen, Managing Director, Scott/Tiger Life Science AG, Switzerland Senior Management View: How Computer Validation Supports the Business and Is Not a Necessary Evil Soeren Stroeh, CEO, acronordic A/S, Denmark 09:00-10:30 Session 1 ADAPTIVE DOSE FINDING STUDIES Frank Bretz, Biostatistics & Statistical Reporting, Novartis Pharma AG, Switzerland Motivation: Poor understanding of the dose response profile (safety and efficacy) of drugs in development has been indicated by both regulatory agencies and industry as one of the leading causes of the pipeline problem currently facing the pharmaceutical industry. In addition, failed Phase III trials are often associated with inappropriate dose selection. Understanding and proper characterisation of dose response profiles is thus critical for both drug developments as well as for post marketing use. This session will focus on adaptive dose finding studies that can generate information to efficiently and reliably characterise the benefit/risk of a drug over a range of doses, leading to better dose selection for the confirmatory stage of development. This information would ideally include a characterisation of the uncertainty in the dose response as well. These ideas all pertain to a better definition and understanding of the therapeutic window of the drug. Adaptive Dose Ranging Studies José Pinheiro, Senior Biometrical Fellow, Novartis Pharmaceuticals Corporation, USA Adaptive Dose Finding Strategies - Technical Side Frank Miller, Senior Statistician, Biostatistics, AstraZeneca R&D, Sweden Panel Discussion with David Wright, Senior Statistical Assessor, MHRA, UK 09:00-10:30 Session 1 REGULATIONS UPDATE Sharon Leighton, Consultant, Sharon Leighton Consultancy, UK This session will discuss existing and future regulations that impact on Medical Information practice. Recent changes to the EFPIA codes will be explained. EFPIA Codes Andrew Robson, Consultant, UK Corporate Compliance Industry representative invited STATISTICS MEDICAL INFORMATION & COMMUNICATIONS European Regulations and EU Commission Plans EMEA representative invited 10:30-11:00 COFFEE BREAK 13

14 CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 11:00-12:30 Session 2 EVOLVING EFFICACY TOOLS IN CLINICAL TRIALS Session Chairperson invited Practical Use of Pharmacoepidemiology in Clinical Drug Development David Neasham, Epidemiologist, i3 Drug Safety, UK Telemedicine: What Can it do for the Pharmaceutical Industry? Scottie Kern, Assistant Director, Wyeth Research, UK Integrating EDC and Medical Imaging Industry representative invited 11:00-12:30 Session 2 SITE MANAGEMENT Session Chairperson invited Drug Accountability: The Site Perspective Nikki Dowlman, Product Manager, ClinPhone Limited, UK Operational Modelling and Simulation in Clinical Trials: Aiding and Enhancing Site Performance Industry representative invited Developing Capabilities at Investigative Sites in Emerging Countries Nermeen Y. Varawalla, Vice President, Investigator Relations, Scientific and Medical Affairs, PRA International, UK 11:00-12:30 Session 2 OPTIMISING PROCESSES UTILISING TECHNOLOGY Stéphane Marzabal, Manager Data Management, Merck Serono International SA, Switzerland For almost ten years now, new technologies have brought a new way of working in Data Management and clinical monitoring. After an initial implementation, many companies have been entering into a second phase of implementation that aims to really use the technology at it's full potential. This session will show example of how the implementation of new processes could help making the new technology most beneficial to R&D. Knowledge Innovation Reduces Time to DBR Liselotte Hyveled, Vice President, Clinical Operations, Novo Nordisk A/S, Denmark Impact of EDC on Clinical Database Finalisation: Advantages and Drawbacks of Different Technologies François Aubin, Medical and Methodology Director, Cardinal Systems, France Challenges for Decentralised Global EDC Implementation Rinske M. Sieders Stoelinga, Manager Data Management, Astellas Pharma Europe R&D, The Netherlands IT/VALIDATION 11:00-12:30 Session 2 VALIDATION OF EDC/ECLINICAL Session Chairperson invited Emerging Validation Techniques in eclinical Trial with Risk Based Strategy - A Case Study James Huang, Director, Quality Assurance and Regulatory Compliance, Almac Clinical Technologies, USA How to Stay Validated after Go-live of a GCP System Teri E. Stokes, Director, GXP International, USA STATISTICS 11:00 12:30 Session 2 CHALLENGES IN EARLY PHASE TRIALS Lisa Squassante, Clinical Pharmacology, Statistics and Programming, Biomedical Data Sciences, GlaxoSmithKline SpA, Italy Early Phase Clinical Trials carry the responsibility of being the first clinical trials to test new chemical entities in human beings. For the first time in drug development subjects will be exposed to a new drug to enable appropriate drug dose selection and to facilitate a first insight of potential drug response. The optimisation process that leads an effective Early Phase Development is driven by scientific objectives and can be facilitated by using relevant tools, such as biomarkers, PK/PD models and clinical trial simulation. Many statistical tools presented in text-books are in the context of late phase clinical trials development that are run in a regulatory environment. These might not be the best suited tools to explore data collected in the Early Phase Trials, where often we are investigating hypotheses and not testing them. This session will focus on some of the statistical challenges that Early Phase Trials have and will offer insights in going beyond the standard pre-defined. Are Confirmatory Tools the Best Tools to Apply to Early Exploratory Trials? Graeme Archer, Director, Psychiatry Discovery Biostatistics, GlaxoSmithKline, UK From Phase I to PoC: Optimising Early Development Heinz Schmidli, Statistical Methodologist, Novartis Pharma AG, Switzerland From Phase IIa to Phase IIb: Pragmatic Optimal Dose Selection and Sample Size Patrick Johnson, Associate Director, Parmacometrics, Pfizer, UK MEDICAL INFORMATION & COMMUNICATIONS 11:00-12:30 Parallel Session 2 RESOURCE MANAGEMENT Sarah Dunnett, Medical Affairs Manager, Baxter Healthcare, UK This interactive session will provide insights into a variety of aspects of managing resources. This will include the use of assessment centres in recruitment and options for outsourcing. Workshop on Resource Management Sharon Leighton, Consultant, Sharon Leighton Consultancy, UK Recruitment and Design of Assessment Centres Liz Clark, Head of Global Medical Affairs, Norgine Ltd., UK Benefits and Pitfalls of Outsourcing Medical Information Services Sophie Graham-Godet, Manager, Accenture, UK Validation of EDC Charles Lankford, CEO, PharmaSys Inc., USA 14

15 11:00-12:30 Parallel Session 2 LIAISING WITH EXTERNAL STAKEHOLDERS John Barber, Director Scientific Affairs, Alliance Pharmaceuticals Ltd., Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK This session will be run by PIPA (Pharmaceutical Information and Pharmacovigilance Association) and will discuss the opportunities to work with external partners. An external stakeholder will give their perspective and an innovative reverse survey of Medical Information perspectives on key customer interactions will be presented. Working with External Stakeholders John Barber, Director, Scientific Affairs, Alliance Pharmaceuticals Ltd., Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK A Stakeholder Speaks Joanne Shaw, Chairman, Datapharm Communications Ltd., UK Reverse Survey Results Janet Taylor, Consultant, Janet Taylor Consultancy Services, UK 12:30-14:00 LUNCH BREAK CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 14:00-15:30 Session 3 SIGNAL DETECTION I Brian Edwards, Director Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK Early signal detection with prompt and effective action is essential to safe clinical development programme and reassuring clinical trial subjects in the safety of their trial. This session will examine different perspectives of achieving this. The Role of the Statistician in Data Monitoring Committees Fritz Schindel, Head, Biostatistics Marburg, Accovion GmbH, Germany Detecting Safety Signals from Clinical Trials Janet E. Scott, Director, Safety Evaluation and Risk Management, GlaxoSmithKline R&D Ltd., UK Methodical Signal Management (MsM): Best Practices for Efficient and Effective Pharmacovigilance Sanket Agrawal, President, CEO, Briskvantage, Inc., USA What Clinical Forum 2007 delegates had to say: The speakers gave excellent and very practical presentations Lots of shared practical experience from expert speakers. good mix of pharma, contractors, regulators What Clinical Forum 2007 delegates had to say: Great sessions and meeting, please continue! Especially information sharing across companies best pracice sharing 14:00-15:30 Session 3 STUDIES IN ASIA Nermeen Y. Varawalla, Vice President, Investigator Relations, Scientific and Medical Affairs, PRA International, UK The three key clinical development regions in Asia namely India, China and South East Asia offer similar attractions and pose similar issues with respect to the placement of international clinical trials. The key attraction remains timely, cost effective patient recruitment; driven by large patient populations with huge unmet medical need and the opportunity to enrol highly productive clinical trial sites. The nascent clinical trial environment with limited experience and lengthy regulatory approval processes is a concern. However as these regions build a track record and enjoy rapid growth in the number of international clinical trials being conducted, the capacity constraints at clinical sites and shortage of trained personnel need to be urgently addressed. Sponsors perspective on working throughout the region Industry representative invited Conducting Multinational Trials in China James D. Fan, Associate Medical Director, Asia Pacific Region, ICON Clinical Research Ltd., Singapore Fast Changing Clinical research sector in India Nermeen Y. Varawalla, Vice President, Investigator Relations, Scientific and Medical Affairs, PRA International, UK 14:00-15:30 Session 3 STANDARDS/CDISC Pierre-Yves Lastic, Senior Director, Standards Management & Data Privacy, sanofi-aventis, France General Update on CDISC Pierre-Yves Lastic, Senior Director, Standards Management & Data Privacy, sanofi-aventis, France Evaluation of CDASH From an EDC Vendor Perspective Philippe Verplancke, CEO, Xclinical, Germany Industry representative invited IT/VALIDATION 14:00-15:30 Session 3 VALIDATION OF epro Teri E. Stokes, Director, GXP International, USA Validation of epro - Comparing Electronic Data Capture with Paper Brian Tiplady, Senior Clinical Scientist, invivodata, Inc., UK Validation of epro Industry Perspective Industry representative invited Validation of epro System Jean Paty, Founder and Senior Vice President, Quality and Regulatory Affairs, invivodata Inc., USA 15

16 STATISTICS 14:00-15:30 Session 3 HEALTH ECONOMICS John William Stevens, Lecturer, Deputy Director of the Centre for Bayesian Statistics in HE (CHEBS), University of Sheffield, UK Reimbursement authorities such as the National Institute for Health and Clinical Excellence (NICE) in the UK are interested in maximising health for patients under their care using interventions that provide value for money. Generating the necessary evidence to be able to make a decision involves many statistical issues and process that are relatively new to many statisticians who may be more familiar with issue in drug registration. In this session, we will present some some statistical issues arising from an indirect comparison between interventions in hypertension, consider some issues in the identification of subgroups in Health Technology Assessment (HTA), and hear about some experiences and lessons learnt from the perspective of a statistician involved in NICE submissions. Statistical Issues Arising from an Indirect Comparison in Hypertension Richard Nixon, Statistician, Novartis Pharma AG, Switzerland NICE Submission and Case Study Examples - Lessons Learnt Christine Fletcher, Director and Head of International Biostatistics, Amgen, UK Identification of Subgroups in HTA Dominic Muston, Technical Lead, Heron Evidence Development Ltd., UK MEDICAL INFORMATION & COMMUNICATIONS 14:00-15:30 Parallel Session 3 QUALITY MANAGEMENT Yvelise Schwartz-Dizier, Head of Global Medical Information Services, Global Medical Affairs, MerckSerono International S.A., Switzerland This session will address the importance of managing quality in Medical Information services. Quality management will be discussed as a key principle in Medical Information and practical examples will be presented of quality initiatives in action. Importance of Quality Management in Global Medical Information Lillian Auberson, Director Global Medical Information, Actelion Pharmaceuticals Ltd., Switzerland SOP s, Training for Quality Sarah Dunnett, Medical Affairs Manager, Baxter Healthcare, UK Qualitative Market Research of Medical Information Standard Responses Sabine Lischka-Wittman, Senior Manager Medical Information, Lilly Deutschland GmbH, Germany 14:00-15:30 Parallel Session 3 WRITING SKILLS Instructor: Jayne Packham, Consultant, Jayne Packham Consultancy Ltd., UK This workshop will provide practical advice on improving writing skills to enhance clear communications with healthcare professionals and patients. 15:30-16:00 COFFEE BREAK CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 16:00-17:30 Session 4 SIGNAL DETECTION II Brian Edwards, Director, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., UK Given that signal detection is the prime purpose of pharmacovigilance, we should strive to continuously improve our processes. This forward-looking session provides insight into what future innovations will help us and what industry best practices should look like. Annual Safety Reports - Current and Future Challenges Véronique Basch, Head of Drug Safety, HPM SA Geneva, Switzerland Evolving CDISC Standards Enable New Safety Data Analysis Tools Sally Cassells, Vice President of Clinical Systems, Phase Forward Inc., USA 16:00-17:30 Session 4 THE CLINICAL SITE - COLLABORATION, SUPPORT AND INSPECTIONS Nick Lucas, Vice President, Global Data Management, INC Research, UK The clinical site is a critical component to any trial - it is essential that the relationship between the site and all other participants is supported so that the clinical trial runs as successfully as possible. Considering the technologies used to support clinical trials, the relationship with sites and the multiple participants, the delivery of the trial can be extremely challenging. This session is designed to highlight differing challenges faced in working with and supporting clinical sites. We will examine challenges as diverse as 'Investigator Payments Across Europe', 'Preparation of Sites for e-source related Inspections' and Multilingual EDC Site Support'. The topics in this session are broad - and focus on providing effective support to clinical sites. Challenges with Paying Investigators in Europe Pamela Howard, VP Clinical OPS, ICON Clinical Research, Ireland Preparing Study Sites for Audit and Inspection of Electronic Source Data and Computerised Systems Teri E. Stokes, Director, GXP International, USA Multilingual EDC Support - A Case Study David W. Hanaman, Chief Sales & Marketing Officer, Co Founder, C3i, USA 16:00-17:30 Session 4 DATA INTEGRATION Stéphane Marzabal, Manager Data Management, Merck Serono International SA, Switzerland The burden of external data is currently increasing to a level that makes their management even more time consuming than the CRF data themselves. We are now receiving data for even more centralised reader (Laboratory, MRI, ECG, PETSCAN,...) plus a new set of data coming these days from academics laboratories ( biomarkers...) that are not familiar to data export. This session will show some approach to integrate or centralise directly these data to overcome and decrease the workload coming with these tasks. Integration EDC and Medical Imaging Gunter Bellaire, Director Operations, Medical Imaging, Perceptive Informatics, Germany 16

17 Virtual Central Laboratory in Phase III Oncology Trials from a Sponsor Perspective Marc-Ulrich Haeusler, Senior Clinical Data Manager, Merck KGaA, Germany Rising to the Ever-Increasing Integration Challenge Theuns Bouwer, Principle Consultant, Phase Forward Europe Ltd., UK IT/VALIDATION 16:00-17:30 Session 4 VALIDATION OF OTHER CLINICAL SYSTEMS Jean Paty, Founder and Senior Vice President, Quality and Regulatory Affairs, invivodata Inc., USA Experience with Validation of a Pharmacovigilance Database in a Global Company Solveig Blomvik, Director Pharmacovigilance, Lindeq A/S, Norway Validation of Pharmacovigilance Systems Andy G. Cochrane, Senior Project Analyst, MHRA, UK Validation of an Electronic Regulatory Submissions System Ted Hanebach, Director, Regulatory Standards & New Technologies, CanReg Inc., Canada MEDICAL INFORMATION & COMMUNICATIONS 16:00-17:30 Parallel Session 4 INTERFACE WITH PHARMACOVIGILANCE Stephen Grogan, Manager, Strategy and Regional Integration, Global Medical & Scientific Affairs, Takeda Pharmaceuticals Europe, UK This session will provide practical examples of successful interactions between the Medical Information and Pharmacovigilance functions. Literature Screening Process run by Medical Information to Support Pharmacovigilance Jeroen Dumon, Director Medical Affairs Europe - Scientific Information, Astellas Pharma GmbH, Germany MedicaI Information Pharmacovigilance Interface Rajinder Johal, Medical Information and Drug Safety Executive, Norgine Pharmaceuticals Ltd., UK Outcome of Internal Johnson & Johnson Pharmacovigilance Quality Assurance Audit Jin Vermaat, Medical Affairs Europe, Centocor B.V., The Netherlands 17:30-18:30 RECEPTION 19:00-21:00 NETWORKING DINNER STATISTICS 16:00-17:30 Session 4 10 YEARS OF ICH E9 David Wright, Senior Statistical Assessor, MHRA, UK The ICH harmonised tripartite guideline Statistical Principles for Clinical Trials, more commonly referred to as ICH E9, was adopted by the regulatory bodies of the European Union, Japan and the USA in This document united related guidance documents on statistical methodology from each of the three ICH regions, and meant that for the first time clear consistent guidance on statistical principles was available to those conducting and reviewing clinical trials. On the 10th anniversary of the guideline s adoption, this session will explore what were the key issues when the document was written and given a current regulatory and industry perspective on how approaches to some aspects of clinical trial design, conduct and analysis have changed in the last ten years in the context of regulatory submissions in the European Union. The Development of ICH E9 Guideline - Challenges and Achievements Bernhard Huitfeldt, Independent Advisor, BH Statistical Consulting, Sweden Has ICH E9 Improved the Methodological Quality of Regulatory Submissions? David Wright, Senior Statistical Assessor, MHRA, UK Industry Perspective of ICH E9 and Future Challenges Christine Fletcher, Director and Head of International Biostatistics, Amgen, UK What Clinical Forum 2007 delegates had to say: Presentations were very well documented and can be used as a starting point to search for more info Wednesday, October 22, 2008 CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 09:00-10:30 Session 5 OPTIMISATION OF SAFETY DATA HANDLING Yves Tellier, Head of Data Management, GlaxoSmithKline, Belgium While new technologies claim they can fasten data collection, minimise manual operations and optimise resources utilisation, the one area where they haven't succeeded so far is definitely the SAE (Serious Adverse Events) domain: most companies still rely on the classical paper collection and manual reconciliation processes. Can obstacles be overcome? What are the benefits and the underlying pitfalls? Here are three case studies where companies have explored different technological paths to improve the way SAE are handled. Application of EDC to SAE Collection: Case Study Yves Tellier, Head of Data Management, GlaxoSmithKline, Belgium EDC - Challenges in SAE-Intensive Studies Harri T. Paakkulainen, Senior Data Manager/EDC Trainer, Orion Pharma, Finland Process Improvement to Automate SAE Reconciliation Industry representative invited What Clinical Forum 2007 delegates had to say: Everything was interesting and valuable! Very interesting to have a safety session 17

18 CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS STATISTICS 09:00-10:30 Session 5 OPERATIONS ROLE EVOLUTION Detlef Nehrdich, Director Statistics, Data Management & EDC Project Office Europe, Abbott GmbH & Co KG, Germany Most organisations have managed the shift or are on their way to the post eclinical environment. With new technologies and adjusted processes in place the focus of most the roles in clinical development has shifted. This session evaluates which opportunities and challenges are emerging with this ongoing role evolution. The speakers, who all have their very specific and partially provocative perspective, will consider site personnel, the field monitor and the data manager. Heads-up! A new Approach to Site Management Rudi Ladenius, Senior Director, Clinical Operations West & South Europe, PAREXEL, The Netherlands Data Managers Why the Future Looks Good (and How) Joe Anderson, Principal Associate, Waife & Associates, Inc., USA What the Numbers Tell us - New Roles and More Fun! Detlef Nehrdich, Director Statistics, Data Management & EDC Project Office Europe, Abbott GmbH & Co KG, Germany 09:00-10:30 Session 5 QUALITY MANAGEMENT Session Chairperson invited This session is currently in development 09:00-10:30 Session 5 BAYESIAN METHODS IN CLINICAL TRIALS Session Organiser: Peter F. Thall, Professor, Department of Biostatistics, M.D. Anderson Cancer Center, USA Thomas M. Braun, Assistant Professor, Department of Biostatistics, University of Michigan, USA Bayesian methods are being used with increasing frequency in clinical trials, both in their design and in the statistical analysis of final results. The speakers in this session will cover several new methods for early phase trials based on time to toxicity, rather than the more conventional binary indicator, including a method for optimising treatment schedule and two methods for determining an optimal dose while guarding against late onset toxicities. Additionally, a general discussion of data-dependent methods will be presented, including an example. Parametric Approaches for Optimising Treatment Schedules in Adaptive Early-Phase Clinical Trials Thomas M. Braun, Assistant Professor, Department of Biostatistics, University of Michigan, USA The Time-to-Event Continual Reassessment Method Ying Kuen Cheung, Associate Professor, Department of Biostatistics, Columbia University, USA Monitoring Late Onset Toxicities in Phase I Trials Using Predicted Risks Yuan Ji, Assistant Professor, Department of Biostatistics, University of Texas, M.D. Anderson Cancer Center, USA Data-Dependent Designs in Clinical Trials: Their Context and an Example Chris Palmer, Director, Centre for Applied Medical Statistics, University of Cambridge, UK IT/VALIDATION MEDICAL INFORMATION & COMMUNICATIONS 09:00-10:30 Session 5 SYSTEMS SECURITY AND ACCESS CONTROL Session Chairperson invited Steganography as a Means of Applying Digital Signatures Glen Watt, Global Information Security and Privacy, Corporate Security Office, Medidata Solutions Worldwid, USA Signatures and Authentication for Everyone (SAFE) - How Digital Identities and Signatures Support Clinical Trials and esubmissions Richard Furr, Head, Global Regulatory Affairs and Chief Compliance Officer, SAFE BioPharma Association, USA Why System Backups Stored Offsite and Files in SourceSafe are not an Electronic Archive Teri E. Stokes, Director, GXP International, USA What Clinical Forum 2007 delegates had to say: 09:00-10:30 Session 5 WORKING WITH INTERNAL PARTNERS Aaron Cockell, Head of Medical Operations and Information, Pfizer Ltd., UK This interactive session will explore the opportunities to partner with internal colleagues to advance the impact of the Medical Information service. Visibility of Medical Information in a Global Structure Sangeetha Srinivasan, Global Medical Information Senior Specialist, Fertility Global Medical Information, Global Medical Affairs, Merck Serono International S.A., Switzerland Interaction of Medical Information with Internal Departments Aaron Cockell, Head of Medical Operations and Information, Pfizer Ltd., UK 10:30-11:00 COFFEE BREAK 18 A medical information and communications conference has been long overdue in Europe. Thanks to DIA for finally hosting it - yearly updates needed!

19 CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 11:00-12:30 Session 6 PHASE I Rob Nichols, Rob Nichols, Director Commercial Development, Phase Forward Europe Ltd., UK The unique challenges of running Phase I trials have intensified with a refocus on safety after TeGenero, increasingly complex trial designs being utilized, and the need for near real time data from one stage of a trial to inform another stage of the same trial or another trial. This session outlines approaches to adapt to this new environment. These include confirming participants understand the complex studies that they are entering, ensuring multifaceted trials are appropriately planned and managed, and assisting clinical staff conduct these trials with automated solutions. Improving the Readability of the Participant Information Sheet for Phase I Trial by User Testing Peter Knapp, Senior Lecturer, School of Healthcare, University of Leeds, UK Complexity of Planning and Managing Exploratory Clinical Trials Dominique Demolle, Director, Aepodia, Belgium The Power of Automation at Phase I Sites Rob Nichols, Director, Commercial Development, Phase Forward Europe Ltd., UK 11:00-12:30 Session 6 EFFICIENCY OF INVESTIGATOR MEETINGS Ingrid Klingmann, President, Pharmaplex bvba, Belgium Applying Web Training Technology to Investigators' Meetings Darren McDaniel, CEO, Managing Officer, Coast IRB, LLC, USA Additional speakers for this session are invited 11:00-12:30 Session 6 PRO/ePRO I Valdo Arnera, General Manager Europe, PHT Corporation, Switzerland The Use of epro Technology to Support Trial Site Procedures Rainer Richter, Clinical Data Manager, Grünenthal GmbH, Germany Implementing an ediary Solution in a Large Pivotal Phase III Trial - Benefits Thierry H. Escudier, Director, International Clinical Operations,Institut de Recherche Pierre Fabre SAS, France Success Factors to Implement Patient Reported Outcomes Concepts in Clinical Studies Heike Schoen, Managing Director, CSG Clinische Studien GmbH, Germany IT/VALIDATION 11:00-12:30 Session 6 AUDITS AND INSPECTIONS Session Chairperson invited This session is currently in development Update on European Inspections Regulatory representative invited Clinical QA Auditor's View of Computer Validation - Internal and External Systems Marie Lassen, Clinical Auditor, CQA, H. Lundbeck A/S, Denmark Peach Update Glen Watt, VP, Global Information Security and Privacy, Corporate Security Office, Medidata Solutions Worldwide, USA STATISTICS 11:00-12:30 Session 6 MULTIPLE ENDPOINTS: MODERN APPROACHES TO THE PROBLEM FROM A PRACTICAL PERSPECTIVE Sue Todd, Co-Director, Quantitative Biology and Applied Statistics, The University of Reading, UK This session will consider the topic of dealing with multiple endpoints in clinical trials. It will focus on methodology for dealing with multiple endpoints which has clear practical implementation. Special consideration is given to discussion of the relative merits of available methods and new innovations. Using Interim Analyses in Clinical Trials When More Than One Endpoint is of Interest Sue Todd, Co-Director, Quantitative Biology and Applied Statistics, The University of Reading, UK On Testing Simultaneously Non-Inferiority in Two Multiple Primary Endpoints and Superiority in at Least One of Them Christoph Gerlinger, Senior Director Statistics, Bayer Schering Pharma AG, Germany Multiplicity in Adaptive Design Aiming for Biomarker Sensitive Patient Selection Sue-Jane Wang, Associate Director, Adaptive Design and Pharmacogenomics, OB/OTS/CDER, FDA, USA MEDICAL INFORMATION & COMMUNICATIONS 11:00-12:30 Parallel Session 6 COMPLIANCE Françoise Hanotte, Associate Director Medical Information, Global Medical Affairs, UCB S.A, Belgium This session will include discussions of the handling of compliance and legal issues, such as copyright and data privacy, in the provision of Medical Information services. The challenges in reviewing promotional materials for use in multiple countries will also be discussed. Copyright Issues from Perspective of a European Library Service Sascha Hoening, Abbott GmbH & Co. KG, Germany Data Privacy Issues with Global Medical Information System Victoria Vowles, Medical Information Manager, Global Medical Information, Global Medical Affairs, Merck Serono International S.A., Switzerland Promotional Material Review with Single Global Marketing Strategy Joëlle Goffinet, Associate Director, Global Communications Processes & Systems, Head of GPSRC, Global Medical Affairs, UCB Pharma SA, Belgium 19

20 MEDICAL INFORMATION & COMMUNICATIONS CLINICAL DATA MANAGEMENT, eclinical, CLINICAL RESEARCH, CLINICAL SAFETY & PHARMACOVIGILANCE, CLINICAL OPERATIONS 11:00-12:30 Parallel Session 6 FIELD MEDICAL Liz Clark, Head of Global Medical Affairs, Norgine Ltd., UK This session will discuss trends in the development and expansion of field medical roles in Europe. Field Medical Roles Serkan Oray, Associate Director Medical Information & MSL, Global Medical Affairs, UCB Pharma SA, Belgium Field Medical Topic Ed De Jong, Head, Medical & Regulatory Affairs, GlaxoSmithKline BV, The Netherlands 12:30-14:00 LUNCH BREAK 14:00-15:30 PLENARY SESSION Welcome Address Jens Reinhold, Clinical Forum Chairperson 2008 Head of Non-Interventional Studies, Bayer Schering Pharma AG, Germany Brigitte Franke-Bray, Director DIA Europe, Switzerland "This House Believes that 90% of all Data Collected is Rubbish" Julianne Hull, Senior Director, Global Development Data Operations, Wyeth Research, UK Four brave debaters will present their arguments on the topic of data collection during clinical trials and the value it does or does not add. Prof. Andrew P. Grieve, Statistician, Division of Health & Social Care Research, Department of Public Health Sciences, School of Medicine, King's College, UK Dr. Jane Barrett, The Barrett Consultancy, Consultant in Pharmaceutical Medicine, Medico-Legal Affairs and Medical Ethics, UK Dr. Nick Lucas, Vice President, Clinical Data Management, INC Research, UK 16:00-17:30 Session 8 PAEDIATRIC SESSION Thomas Severin, External Affairs Head Pediatrics, Novartis Pharma AG, Switzerland EU Guidance: Ethical Considerations for Paediatric Clinical Trials to Assist Completion of Paediatric Investigation Plans Jane Lamprill, Paediatric Research Consultant/Specialist Paediatric Medical Writer, Paediatric Research Consultancy, UK Additional speakers for this session are invited 16:00-17:30 Session 8 OUTSOURCING - FROM TACTICAL TO PARTNERSHIPS Julianne Hull, Senior Director, Global Development Data Operations, Wyeth Research, UK Outsourcing has changed significantly in the 21st century from a tool to fill an immediate resource need to a visionary strategy. The ultimate goal to create and maintain stable partnerships that mutually strive for reduced drug development cycle times. Companies do not define their core strengths equally and thus there are multiple facets to these alliances and partnerships. This session will include two case studies of partnerships from the pharmaceutical companies. To maintain balance it will also include a presentation from a CRO describing how they continually strive to keep ahead of ever increasing market demands. In-Licensing, Alliances and Clinical Data Management Best Practices Soeren Kristiansen, Senior Director, Data Science, Nycomed GmbH CRO Responses to Changing Market Demands - Novel Models in Vendor Outsourcing Strategy Suzanne Gagnon, Senior Vice President and Chief Medical Officer, ICON Clinical Research Wyeth and Accenture, Five Years for this Novel Clinical Data Management Alliance Julianne Hull, Senior Director, Global Development Data Operations, Wyeth Research, UK Kort Schickfus, ACE Head, Accenture, USA 16:00-17:30 Session 8 PRO/ePRO II Session Chairperson invited This session is currently in development Mr. Joris Cauquil, Consultant, Head of Training, Head of Quality Assurance, AMITIS/Effi-Stat, France will explore all aspects of process, quality, timelines, volume and ultimately the value added by data collected during the running of clinical trials. The audience will have the opportunity to vote at the beginning and at the end of the debate, listen to seasoned professionals provide arguments for both sides and to ask questions of the debaters. These debates are designed to be entertaining and result in interesting facets of topics being aired in a safe way. What Clinical Forum 2007 delegates had to say: I very much liked the session on electronic submissions 15:30-16:00 COFFEE BREAK 20

21 MEDICAL INFORMATION & COMMUNICATIONS 16:00-17:30 Session 8 WEBSITE TECHNOLOGY FOR COMMUNICATIONS Janet Davies, Medical Information Director, Gilead, UK What Clinical Forum 2007 delegates had to say: This session will include real-life examples of the use of website technology to communicate Medical Information to healthcare professionals and business partners. Medical Information Oncology Website for HCPs Cynthia B. Trimboli, Director, Medical Services Operations, Bristol-Myers Squibb, USA I like the integration of different disciplines Presentations were very clear and well organised Secure Website for Sharing Documents with Worldwide Commercial Partner Jeroen Fakkeldij, Medical Affairs Europe, Centocor B.V., The Netherlands Medical Information Websites for Consumer Ozgur Yuksel, Medical Information & Communications Manager, Novartis Products, Turkey 17:30-18:30 RECEPTION Thursday, October 23, :00-15:00 WORKSHOPS THE PARTICIPANTS DAY - LEARNING FOR YOURSELF AND FROM OTHERS On Thursday, conference attendees have the great opportunity to participate in a number of workshops. The workshops will provide expert knowledge from patients, regulators, physicians and industry specialists. An important key component of the workshops will be that participants are asked to share their opinions and experiences thus learning from each other. Topics on offer are: personalised medicine, including real life success stories and how technology may enable ethical aspects of studies, the changing landscape and growing role for non-interventional studies both locally and globally, personal education, training and development. Last, but not least, there will be events designed for your own personal development, showing how to manage international teams and how to cope with extreme workload situations avoiding personal and team member burnout. We look forward to this forum which is created specifically for the conference participants needs. You are cordially invited to join the lively discussions. The workshops are currently in development. Please visit and click on the Clinical Forum icon for further details 15:00 END OF CONFERENCE The Drug Information Association (DIA) has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA DIA is authorized by IACET to offer up to 2.3 CEUs for this programme. If you would like to receive a statement of credit, you must attend the programme, return your evaluation form and complete the online credit request process through My Transcript at Participants will be able to download a statement of credit upon successful submission of the credit request. Disclosure Policy It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the programme audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabelled or unapproved uses of drugs or medical devices. Faculty disclosures will be included in the course materials. 21

22 HOTEL INFORMATION DIA Europe has blocked a number of rooms at special rates and conditions in the hotels mentioned below. Attendees must make their own hotel reservations trough our contracted travel agent: Kompas d.d. Prazakova 4 SI Ljubljana Slovenia / info@kompas-online.net Tel: Demand for hotel accommodation in Ljubljana during the conference dates is high. As such we encourage delegates to book their hotel room as soon as possible by using the link below: Reservation Deadline: September 5, 2008 All rates are per room/night including breakfast, service, taxes and VAT. Hotel Name Single room Double room for single use Double room incl. breakfast incl. Breakfast incl. Breakfast 5-Star Hotels Hotel Lev Star Hotels Austria Trend Hotel (Comfort Rooms) Austria Trend Hotel (Executive Rooms) Best Western Premier Hotel Slon Grand Hotel Union - Garni Grand Hotel Union - Executive Grand Hotel Union - Business Hotel Mons Star Hotels City Hotel Boutique Hotel Antiq Hotel SOCIAL AND NETWORKING EVENTS The Clinical Forum will offer delegates the opportunity to build business relationships and expand their professional contacts at social and networking events each night, while enjoying excellent local food, wine and entertainment. Gain new perspectives, exchange ideas, and generate new clients from one-on-one discussions with speakers, exhibitors and fellow delegates from various industry sectors and 20 countries. Explore the latest technologies on the exhibit floor and connect with colleagues from the industry, government and academia. From refreshment and coffee breaks to interactive working lunches, evening receptions, an optional networking dinner at a unique venue, the Clinical Forum s planned schedule of social and networking events will offer something for everyone. For more information, visit and click on the Clinical Forum icon. 22

23 GENERAL INFORMATION About Ljubljana Slovenia held the EU Presidency for the first time until the end of June 2008, being the first of the twelve new member states that joined the EU between 2004 and Ljubljana Ljubljana, the capital of Slovenia, is a dynamic Central European city, situated 298 m above sea level in a broad basin between the Alps and the Adriatic Sea. The region s climate is continental, with a pleasant average temperature of 19 C during October. The Adriatic coast, the mountains, the wine-growing regions, spas and many historic towns are all within a two-hour drive. In addition, Ljubljana is also just a 2.5 hour drive or train ride to Venice, Italy. Ljubljana is a charming and vibrant city with a high quality of life, featuring a beautiful green city centre with many parks and forest areas. DIA looks forward to welcoming you and your colleagues to Slovenia for the 2nd Clinical Forum! CONFERENCE & VENUE INFORMATION The event will take place at the: The Ljubljana Exhibition and Convention Centre Gospodarsko razstavisce, d.o.o. Dunajska cesta 18, SI Ljubljana, p.p Slovenia The Ljubljana Exhibition and Convention Centre is located in the city centre close to excellent hotels, restaurants and attractions. PASSPORT & VISA REQUIREMENTS Delegates from countries within the European Union will only need a valid passport or ID to travel to Slovenia. All other delegates should contact the nearest Slovenian Embassy or Consulate for visa requirements. PUBLIC TRANSPORTATION & TAXIS Ljubljana is a small town and unless you need to travel outside of the city centre, you can manage easily without using public transportation. Taxis are reasonably priced and there are taxi stands in front of the railway station as well as the bus station. TRAVEL Ljubljana airport is situated 20 kilometres north of Ljubljana in the direction of Kranj. The international airport code is LJU. Previously known as Brnik Airport, it has recently been renamed The Joze Pucnik Airport, after a contemporary Slovenian statesman. Adria Airways flights connect Ljubljana with major European cities: Amsterdam, Athens, Barcelona, Birmingham, Brussels, Bucharest, Copenhagen, Dublin, Frankfurt, Istanbul, Kiev, London-Gatwick, Manchester, Moscow-Sheremetyevo, Munich, Ohrid, Oslo, Paris-Charles de Gaulle, Podgorica, Pristina, Sarajevo, Skopje, Stockholm, Tirana, Vienna, Warsaw and Zürich. Adria Airways offers a 20% discount (economy, business) on the designated applicable fare to the participants and accompanying persons. The number of seats for special fares are limited and might not be available on all flights/dates/days. Reservations can be made at your nearest Adria Airways branch office. For further details, please visit and click on the Clinical Forum icon > Travel/Accommodation section Discount can only be obtained for Adria Airways flights and cannot be included in any other travel cost calculations. Discount may be granted only against presentation of the code CLINICAL FORUM 2008 at the time of ticketing. Applicable dates of travelling: OCTOBER 17-26,