New Strategies for the Post-Marketing Monitoring of Medical Products
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ISP E 201 1Mid-Year Meeting FFlloorreennccee,, ITALY > APRIL 9-11, 2011 JOINTLY SPONSORED BY ISPE • International Society for Pharmacoepidemiology SIF • Italian Society of Pharmacology SIMG • Italian College of General Practitioners PRELIMINARY Meeti ng V enue agenda Grand Hotel Baglioni Symposium April 9, 2011 ******** New Strategies for the Post-marketing Monitoring of Medical Products Piazza Unità Italiana, 6 07 :30 REGISTRATION AFTERNOON SESSION 1 16 :35 Federation of databases to evaluate the arrhythmogenic 50123 - Florence, Italy 09 :00 INTRODUCTION TO PROGRAM NEW APPROACHES IN DRUG SAFETY potential of drugs: Giampiero Mazzaglia, Program Co-Chair, Health Search, SIGNAL DETECTION The ARITMO project Italian College of General Practitioners, Italy Co-chairs Fabrizio De Ponti, Gianluca Trifirò, Program Co-Chair, Erasmus University Giovanni Corrao, University of Milan Bicocca, Italy University of Bologna, Italy Medical Center, The Netherlands & University of Messina, Italy Marie Lindqvist , WHO Collaborating WELCOME ADDRESSES Centre for International Drug Monitoring, Sweden 17 :00 A network of long-term care facilities: Scientific Committee Achille Caputi, Italian Society of Pharmacology Experience from Europe and USA Past-President , University of Messina, Italy 13 :30 From individual case report assessment to Giovanni Gambassi, Sacro Cuore University CO -CHAIR Claudio Cricelli, Italian College of General Practitioners quantitative signal detection using spontaneous of Rome, Italy Giampiero Mazzaglia President , Italy ADR reporting: What are the lessons learned? MD, PhD - Florence (Italy) Stephen J.W. Evans, FISPE, ISPE President, School of Stephen J.W. Evans, FISPE, London School of Hygiene 17 :30 FINAL COMMENTS CO -CHAIR Hygiene & Tropical Medicine London, United Kingdom and Tropical Medicine, UK Giampiero Mazzaglia, Health Search, Gianluca Trifirò Italian College of General Practitioners, Italy MD, PhD - Rotterdam (The Netherlands), Messina (Italy) MORNING SESSION 13 :55 Data driven discovery-case studies Gianluca Trifirò, Erasmus University Medical Center, The from patient records and spontaneous reports Netherlands & University of Messina, Italy POST-MARKETING MONITORING OF MEDICAL Niklas Noren , WHO Collaborating Frank Andersohn Stephen J.W. Evans PRODUCTS: EXPECTATIONS AND FUTURE Centre for International Drug Monitoring, Sweden 17 :45 ADJOURNMENT MD - Berlin (Germany) BA, MSc, Stat, FISPE DIRECTIONS FROM REGULATORY AGENCIES, London (UK) INDUSTRY, AND ACADEMIA 14 :20 Does data mining on healthcare database add to safety monitoring: Results from the EU-ADR project Roberto Bernabei Co-chairs University of Messina, Italy Miriam Sturkenboom, FISPE, Erasmus University Medical MD - Rome (Italy) Nicholas Moore Achille P. Caputi, COURSES April 10, 2011 MD, PhD, FRCP, FISPE Nicholas Moore, FISPE, University of Bordeaux, France Center, The Netherlands Bordeaux (France) Achille P. Caputi 09 :15 KEYNOTE ADDRESS 14 :45 The Observational Medical Outcomes Partnership 07 :30 REGISTRATION MD - Messina (Italy) Evaluating drug effect in the post-Vioxx world: (OMOP): Results and future perspectives Alessandro Mugelli There must be a better way Patrick Ryan, Johnson and Johnson , USA MORNING INTRODUCTION TO MD - Florence (Italy) Jerry Avorn, FISPE, Harvard Medical School/Brigham & PHARMACOEPIDEMIOLOGY Claudio Cricelli Women’s Hospital, USA 15 :15 BREAK MD - Florence (Italy) Pharmacovigilance Sebastian Schneeweiss Q & A DISCUSSION Mauro Venegoni, Regional Health Authority of Lombardy, Italy MD, ScD, FISPE AFTERNOON SESSION 2 Boston, MA (USA) Cohort studies Giovanni Corrao 10 :00 Active monitoring of medical product safety: PhD - Milan (Italy) Charité University of Berlin, Germany A viewpoint from the Italian Medicines Agency PROMOTING DISTRIBUTED NETWORKS Frank Andersohn , FOR HYPOTHESIS TESTING STUDIES: Miriam Sturkenboom Daniela Melchiorri , Italian Medicines Agency & Committee Case-control studies CURRENT INITIATIVES IN EUROPE Mark H. Epstein PharmD, PhD, FISPE for Human Medicine Products, EMA Giuseppe Traversa, Italian Health National Institute, Italy ScD - Bethesda, MD (USA) Rotterdam (The Netherlands) Co-chairs 10 :30 Issues driving the European regulatory agenda Roberto Bernabei, University Cattolica del Sacro Cuore Confounding Rome, Italy on drug risk-benefit management: The importance Corinne de Vries, FISPE, University of Bath, UK of risk minimization activities Miriam Sturkenboom, FISPE, Erasmus University Medical Center, The Netherlands Almath Spooner , Irish Medicines Board & Pharmacovigi - AFTERNOON ADVANCED TOPICS lance Working Party, EMA Organizing Secretariats 15 :45 The European Network of Centres IN PHARMACOEPIDEMIOLOGY ACCOMMODATION 11 :00 BREAK for Pharmacoepidemiology (ENCePP): REGISTRATION Code of conduct for multicentre Conducting hypothesis testing research SPONSORSHIP & EXHIBITION in healthcare databases: Workflows in single observational studies 11 :30 Post-marketing drug safety monitoring and multiple database studies and risk minimization activities: Stella Blackburn, Pharmacovigilance and Risk Manage - Miriam Sturkenboom, FISPE, Expectations and proposals from drug industries ment, European Medicines Agency, UK Erasmus University Medical Center, The Netherlands ISPE AIM GROUP INTERNATIONAL Philippe Van der Auwera, Risk Management Strategies, 5272 River Road, Suite 630 Florence Office Hoffmann-La-Roche, France 16 :10 The future of vaccine safety assessment in Signal detection in electronic medical record and Bethesda, MD 20816 USA Viale G. Mazzini, 70 Europe: The perspective from VAESCO project claims databases versus spontaneous Ph.: +1-301-718-6500 50132 Florence, Italy 12 :00 Making sense of safety monitoring data: Bringing Jan Bonhoeffer, University Children's Hospital Basel, reporting databases epidemiology and decision sciences together Basel, Switzerland & Brighton Collaboration Fax: +1-301-656-0989 Ph.: +39-055-23388.1 Kevin Haynes, University of Pennsylvania, USA Sebastian Schneeweiss, FISPE, Harvard Medical School/Brigham www.pharmacoepi.org Fax: +39-055-3906908 & Women’s Hospital, USA Update on effectiveness research using [email protected] www.aimgroup.eu/2011/ispe observational databases [email protected] 12 :30 LUNCH Tobias Gerhard , Rutgers University, USA Quality of evidence of observational studies in drug safety: the work in progress of GRADE Nicola Magrini, CEVEAS Bologna, Italy Multiple-treatments meta-analysis www.pharmacoepi.org Corrado Barbui, University of Verona, Italy.