Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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42 This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 14:00-15:00 Session 1504 STUDENT SESSION in partnership with European Pharmacy Students Association (EPSA) & International Federation of Medical Students' Associations (IFMSA) DIVERSE CAREER PATHS – LOOKING BEYOND THE HOSPITAL/PHARMACY: A PANEL DISCUSSION Co-Chairs: Fokion Sinis, Vice President European Affairs, EPSA IFMSA Representative TBC The DIA in partnership with the European Pharmacy Students Association (EPSA) and the International Federation of Medical Students Associations (IFMSA) are hosting a panel discussion with experienced professionals who studied medicine/pharmacy and subsequently forged a successful career in the pharmaceutical profession. Each panellist will outline their career path into the pharmaceutical world and will discuss their current roles and responsibilities as well as how they see the profession changing in the future. This session aims to present to students the diverse range of options that the pharmaceutical profession can offer medical and pharmacy students. Brigitte Franke-Bray, European Director, Drug Information Association, Switzerland Truus Janse-De Hoog, Staff Member European Cluster, Medicines Evaluation Board, The Netherlands June Raine, Director, Division of Risk Management of Medicines, MHRA, UK Dagmar Stara, Faculty of Pharmacy, Comenius University in Bratislava, Slovakia VARIATIONS Session Chair: Keith Pugh, Assessor, MHRA, UK Session under development Hot Topics/Stand-Alone Sessions Session 1604 16:00 Session 1405 REGULATORY IT STRATEGIES & STANDARDS BODIES- IS THERE A COALESCENCE? WHAT SHOULD THE NEXT INNOVATION BE TO ENHANCE PATIENT SAFETY? Session Chair: John Balian, Senior Vice President, Head of Global Pharmacovigilance & Epidemiology, Bristol-Myers Squibb, USA "Drug safety is a foundation of drug regulation," stated CDER Director, Dr. Janet Woodcock. Recent FDA guidances, press releases, and public pronouncements have made a point of making public its commitment to drug safety. The European Medicines Agency and the FDA have a broader vision for safety standards and surveillance. From potential changes in coding to SnoMed to the adoption of the HL7 (RIM) Reference information model, to the imposition of steep fines when REMS not implemented, an innovative model is needed for the industry to meet the increasingly challenging environment. REMs and RMPs in the Current Environment Amrit Ray,Chief Safety Officer, Johnson and Johnson, USA Drug Safety and Personalised Medicine: The role of Interoperability and Enterprise Architecture Charles Mead, Senior Director, Healthcare and Life Sciences Strategy, Booz Allen Hamilton, Chief Technology Officer, NCI, USA Signal Prediction in Early Development, Integrated Signal Detection throughout the Lifecycle Philippe Van der Auwera, Global Head of Safety Risk Management & EEA-QPPV, F. Hoffmann-La Roche AG, Switzerland Session 1605 SUBMITTING A QUALITY DOSSIER (MODULE 2 & 3) / E-SUBMISSION Session Chair: Christa Wirthumer-Hoche, Head, Unit for Marketing Authorisation and Lifecycle Management of Medicinal Products, AGES PharmMed, Austria Submitting Quality data, especially for QbD, in CTD is discussed. Specific guidance on e-CTD, in order to avoid pitfalls is given, as well as a general overview on the current situation on e-submissions in Europe from a regulatory point of view is presented. Concepts of CMC-Document Structure – Where to put QbD data Speaker invited Avoiding Pitfalls When Choosing CMC Attributes for eCTD Submissions (Module 2 & 3) Phyllis Thomas, CMC Documentation Advisor, Pharmaceutical & Analytical R&D, Astra Zeneca, UK e-Submissions – Where do we stand? Regulatory point of view Christa Wirthumer-Hoche, Head, Unit for Marketing Authorisation and Lifecycle Management of Medicinal Products, AGES PharmMed, Austria Wednesday, March 10, 2010 09:00 Session 1406 META-ANALYSIS FOR EVALUATION OF RISKS IN NEW TREATMENTS Session Chair: Joachim Vollmar, Executive Consultant, International Clinical Development Consultants LLC, USA Recently, the FDA issued a Guidance for Industry on "Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes". It is requested that sponsors perform a meta-analysis of cardiovascular events across phase 2 and 3 controlled clinical trials and explore similarities and/or differences in subgroups. Before submission of the NDA/BLA the incidence of important cardiovascular events occurring with the investigational agent and with the control group are to be compared. This session will describe the basic statistical concepts and implications, present the FDA's and European Agency's view and have a panel discussion with clinicians, pharmacovigilance experts and statisticians. Industry Perspective Jürgen Kübler, Global Head Integrated Safety & Health Economics Biostatistics, Novartis, Switzerland Evaluating Risks in New Treatments FDA speaker invited STUDY ENDPOINTS Session Chair: To be confirmed Session 1606 11:00 Session 1407 HOW DO YOU ENSURE THERAPEUTIC EQUIVALENCE WITH SUFFICIENT CONFIDENCE? Session Chair: Jan Müller-Berghaus, Division of Immunology, Paul-Ehrlich-Institut, Germany Session under development
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme. 11:00 Session 1507 JAPANESE REGULATORY SESSION: PMDA UPDATE - INITIATIVES AND CHALLENGES FOR PROMOTING GLOBAL DRUG DEVELOPMENT Session Chair: Kyoichi Tadano, Director, Division of Planning and Coordination, PMDA, Japan In this session, you will hear a detailed review of the past year at PMDA as well as an overview of initiatives, milestones and current trends for the next year. You will hear directly from senior-level PMDA representatives on issues that may significantly affect your organisation’s regulatory operations Future Directions and Challenges of PMDA Tatsuya Kondo, Chief Executive, PMDA, Japan Current Status of New Drug Reviews and Challenges to Promote Global Drug Development Satoshi Toyoshima, Executive Director and Director, Center for Product Evaluation, PMDA, Japan Current Projects for Promoting Global Drug Development including Japan Yoshiaki Uyama, Review Director, Office of New Drug III, PMDA, Japan 11:00 Session 1607 PRODUCT INFORMATION MANAGEMENT – PROGRAMME TO MOVE ALL PRODUCT INFORMATION IN THE CENTRALISED PROCEDURE TO PIM Session Chair: Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline, UK The European Medicines Agency has issued a Statement of Intent regarding the migration of all product information to PIM format by the end of 2011. The use of PIM is strongly recommended for new products from mid-2010 and for authorised products from when the product information is migrated. A programme of work to achieve these goals is underway. European Medicines Agency Plans to Transition PIM to the Standard Way of Working Olivier Simoen, Head of Programme and Project Management, European Medicines Agency, EU The Process for Migration to PIM Mo Gould, Project Manager, FIT Consortium at the European Medicines Agency, EU Practical Experience of Migrations Lynsey Flitton, Senior Regulatory Labelling Manager, Global Regulatory Affairs, Wyeth Europa, UK 14:00 Session 1408 DRAWING THE BORDERLINE BETWEEN MEDICINES AND OTHER CATEGORIES OF SELF-CARE PRODUCTS: A NEVER-ENDING TASK FOR REGULATORS IN EUROPE? Session Chair: Christelle Anquez-Traxler, Regulatory and Scientific Affairs Manager, AESGP, Belgium The session will review the regulatory requirements which apply in order to clarify certain borderline issues between medicinal products and other product categories, namely medical devices used in self-care, food supplements and cosmetics. Despite the provisions introduced by Directive 2004/27/EC to bring clarification in the area, differences in assessment between EU Member States remain frequent, resulting in a regulatory framework potentially uncertain for both industry and consumers. Latest Developments in the Borderline between Medicines and Food Lucca Battistini, Manager, Food Related Issues, AESGP, Belgium Hot Topics/Stand-Alone Sessions Borderline Medical Devices - Medical Products Peter Lassoff, Vice President, Europe, PAREXEL Consulting, UK Borderline Medical Products vs. Cosmetics Speaker invited 14:00 Session 1508 PHARMACEUTICAL MEDICINE (IN COLLABORATION WITH IFAPP) Session Chair: Jean-Paul Deslypere, Business Development Manager, Life Sciences - Asia Pacific, SGS Life Sciences Services, Singapore Pharmaceutical Medicine (PM) can be defined as the discipline of medicine that is devoted to the discovery, research, development and support of ethical promotion and safe use of pharmaceuticals, vaccines, medical devices and diagnostics. Thanks to its important role in overseeing the process of developing new therapeutics it will greatly contribute at improving the standards of health and the quality of life within society. Although PM already has existed for more than 30 years it is still not well known within the medical profession and even amongst the clinical research community. This session aims to familiarise DIA participants with the specialisation of PM, and its professional representative groups: IFAPP and CEPM. The past and future achievements of IFAPP and CEPM will be highlighted as well as the major targets of these organisations: recognition of PM as a separate medical specialty and training of all involved in PM. For this, courses need to be set up and accredited, while participants who successfully finish the courses need to be certified. The experience with PM in the different continents will be discussed with contributions not only from very experienced countries but also from countries were PM is just organising itself. Last but not least some important future projects co-sponsored by the European Union authorities will be presented. IMI 16 Fritz Buehler, European Center of Pharmaceutical Medicine, ECPM Executive Office, University Hospital Basel, Switzerland Pharmaceutical Medicine in Japan Stewart Geary, Vice President, Eisai Co. Ltd., Japan Pharmaceutical Medicine in China Frank Fan, Medical Director, Wyeth Ltd., China Session 1608 THE FUTURE OF TELEMATICS IN EUROPE Session chair: Raun Kupiec, Senior Director regulatory Affairs – Process Management, Genzyme, Netherlands The importance of electronic interchange between applicant and regulator and between regulators increases month by month but where is it heading overall. The direction of the European Medicines Agency is laid out in the Telematics Master Plan but this needs to be regularly redefined as new drivers are identified. Industry is a key stakeholder in this but what direction does it feel should be taken and does it align with those defined by the regulators? The eCTD specification is under redevelopment and in time this may have a major impact on all stakeholders. Progress will be reported and future directions defined. The European Medicines Agency Telematics Master Plan – Continuing Progress Tim Buxton, Head of Sector, Project Management, European Medicines Agency, EU The Industry Vision for Telematics support for European Regulatory Procedures Steve Hasler, Vice President, Global Regulatory Operations, GlaxoSmithKline, UK eCTD Next Major Version – The European perspective Stan van Belkum, Programme Manager, Medicines Evaluation Board, The Netherlands 43
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Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

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