Wednesday August 24, 2015

Transcription

1 32 nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management August 25-28, 2016 Convention Centre Dublin Dublin, Ireland PRELIMINARY AGENDA [TIMES AND CONTENT SUBJECT T0 CHANGE] All sessions will be held at the Convention Centre Dublin Wednesday August 24, :30-6:00pm 7:30-5:00pm 9:00-5:00pm Registration Speaker Ready Room ISPE Board of Directors Meeting Spencer Hotel (Open to ISPE members; notify ISPE staff if you would like to attend.)

2 PRE-CONFERENCE EDUCATIONAL SESSIONS* (*Registration required) ALL DAY COURSE 8:00am-6:00pm Pharmacogenetics for Pharmacoepidemiologists HALF-DAY SESSIONS 8:30-12:30pm Introduction to Pharmacoepi Pediatric Pharmacoepi Medical Devices Intro to Risk Management Adherence 12:30-2:00pm LUNCH ON YOUR OWN PRE-CONFERENCE EDUCATIONAL SESSIONS* (*Registration required) HALF-DAY SESSIONS 2:00-6:00pm Comparative Effectiveness Research Databases Newcomer/Early Stage Pharmacoepi Workshop Benefit Risk Assessment Protocol Writing & Programming

3 THURSDAY August 25, :30-6:00pm 7:30-5:00pm Registration Speakers Ready Room PRE-CONFERENCE EDUCATIONAL SESSIONS* (*Registration required) HALF-DAY SESSIONS 8:30am-12:30pm Intermediate Pharmacoepi Introduction to Drug Utilization Propensity Scores in Pharmacoepi Pharmacovigilance & Signal Detection Registries/Prospective Cohort Modern Pregnancy Pharmacoepi 12:30-2:00pm LUNCH ON YOUR OWN 12:30-2:00pm New Investigator/New Member Luncheon (By Invitation) PRE-CONFERENCE EDUCATIONAL SESSIONS* (*Registration required) HALF-DAY SESSIONS 2:00-6:00pm Advanced Pharmacoepi Advanced Drug Utilization Biosimilars Vaccines

4 Non-database Pharmacoepi Regulatory Pharmacoepi 6:00-7:00pm Welcome Reception/Academic Showcase/Regional Chapter Showcase 7:30-9:30pm Students/Young Professionals Night Out - Registration Required Limited Capacity - Organized by the ISPE Student Council

5 FRIDAY August 26, :00-6:00pm 7:00-5:00pm 7:00-8:15am 7:00-8:00am Registration Speakers Ready Room Poster Session A Set-up Guidelines for Cross-national Comparison of Drug Utilization DRAFT for Comment (OPEN TO ALL INTERESTED) Robert Vander Stichele This special session will present the draft guideline, produced by a group of experts from IMI-Protect, EuroDURG and WHO CC for Pharmaceutical Policy and Regulation. The project was selected and funded by the ISPE Strategic Planning Committee under the Society's Call for Manuscripts Initiative. Based on a literature search, a review template for CNC DU studies was built to address the main methodological issues, (standardize the information extraction, assess the risk of bias in the exposure estimation of each country or region compared, and evaluate the validity of the comparison between countries or regions). The information gathered was used to develop good practice guidelines for designing, conducting, analyzing and reporting CNC DU studies. The project leaders will present the results and discuss with the audience whether the following areas were well addressed: reliability and validity of population coverage; drug coverage; drug terminology issues; biases affecting accuracy and precision of exposure estimates. Comments will be collected and embedded in a final draft of the guidelines. Next steps will be discussed to ensure that standardized guidelines will enhance the validity and reliability of CNC DU studies, and facilitate their peer review, correct interpretation of CNC DU studies, and adequate translation into pharmaceutical policy decision-making. The final draft of the guidelines will be submitted to the ISPE membership for comments consistent with the ISPE Policy Manual and sent to the ISPE Board for action.

6 7:30-8:00am 7:30-6:00pm CHAPTER MEETINGS (OPEN TO ALL INTERESTED) Gulf Region Latin America FarmacoEpiEnRed Exhibits/Posters 8:00-8:30am WELCOME Mary Ritchey Chair, 2016 Scientific Program Committee Kathleen E. Bennett Chair, 2016 Local Host Committee Sonia Hernandez-Diaz, FISPE President, ISPE 8:30-10:00am 10:00-10:30am KEYNOTE SESSION: The Effect of Pharmacoepidemiology on Policy, Populations, And Individual Patients (preliminary) Robert Califf, MD, Commissioner for Medical Products and Tobacco, US Food and Drug Administration CANCELLED Break/Posters/Exhibits 10:30 -Noon CONCURRENT SESSIONS: CONTRIBUTED PAPERS Noon -1:30pm Lunch/Poster Session A/Exhibits Roundtable Discussions - TBA ISPE Committee/Council Meetings Open to all participants. Fellowship & Awards Committee Finance Committee Global Development Committee Membership Committee Public Policy Committee Student Council (open to all students) 12:15-1:15pm Spotlight Poster Session

7 1:30-3:00pm 3:00-3:30pm 3:30-5:00pm CONCURRENT SESSIONS: CONTRIBUTED PAPERS Break/Posters/Exhibits PLENARY SESSION: Real World Effectiveness: How Effective is It? Health organizations, decision makers and regulators sometimes require information on real world effectiveness of medicines after authorization (post-authorization effectiveness studies, PAES). When evaluating real world effectiveness, observational evidence may be required as randomized controlled trials are inappropriate, impossible or inadequate. Delivering timely decision relevant data is essential, however, because of the potential for bias, it has been suggested that observational studies are only suitable for the study of adverse (non-predictable) effects of drugs and not for measuring their intended effects. Much ongoing research is focused on determining the value of observational studies in effectiveness evaluation and the inference that can be drawn from such analyses. The IMI GetReal initiative ( is one example that aims to show how robust new methods of RWE collection and synthesis could be adopted earlier in pharmaceutical R&D and the healthcare decision making process. This plenary session will focus on the real world effectiveness from different perspectives (decision makers, academics, regulators) and the challenges that are encountered as well as offering thoughts on the how research could and should evolve. Specific topics covered during this session include: Breadth/types of research aims/objectives across perspectives/countries Timely and relevant data for decision makers/regulators etc. Generating or retrieving data for effectiveness research (e.g. claims data for outcomes research, electronic health records) Methodological considerations of bias and confounding SPEAKERS Sarah Garner, Science, Policy and Research, National Institute for Health and Care Excellence Elizabeth B. Andrews, FISPE, VP, Pharmacoepidemiology and Risk Management, RTI-Health Solutions Tjeerd van Staa, Health eresearch Centre, Farr Institute for Health Informatics Research & University of Manchester

8 MODERATOR Almath Spooner, Pharmacovigilance and Risk Management Lead, HPRA & Vice Chair EMA's PRAC, Health Products Regulatory Authority, Ireland 5:00-6:30PM 6:30-7:15pm CONCURRENT SESSIONS: SYMPOSIA AND WORKSHOPS Special Interest Group (SIG) Meetings Open to all participants. Adherence SIG AsPEN SIG Biologics & Biosimilars SIG BRACE SIG Comparative Effectiveness Research SIG Database SIG Drug Utilization/Health Services Research SIG Medical Devices SIG Medications in Pregnancy SIG Molecular Epidemiology/Biomarkers/Pharmacogenetics SIG Pediatrics SIG Vaccines SIG 8:00PM PDS Editorial Board (By Invitation/Off site)

9 SATURDAY August 27, :00-6:00pm 7:00-5:00pm 7:00-8:00am 8:00-6:00pm 8:00-9:30am 9:30-10:00am 10:00-11:30pm Registration Speakers Ready Room Poster Session B Set-up Exhibits/Posters CONCURRENT SESSIONS: CONTRIBUTED PAPERS Break/Posters/Exhibits PLENARY SESSION: Patient Voice in Clinical and Pharmacoepidemiologic Research A number of patient-centered initiatives are adding the patients voice to clinical and pharmacoepidemiologic research platforms to better understand the benefits and risks of a pharmaceutical product. These initiatives include Patient- Centered Outcomes Research Institute (PCORI), FDA's Patient- Focused Drug Development Initiative, Canada s Strategy for Patient-Oriented Research (SPOR) and European Patients' Academy on Therapeutic Innovation (EUPATI). These organizations have found that including patients and other stakeholders in the research process, from topic selection through dissemination and implementation of results, will lead to more acceptable and usable information likely to be taken up in practice. This plenary session will focus on current efforts to include the patients voice in clinical and pharmacoepidemiologic research. Speakers will be asked to comment on patient engagement as it relates to benefit-risk, safety and pharmacoepidemiology studies. Specific topics covered during this session include: Evolving paradigm (including, how should pharmacoepidemiologists leverage patients voice in their research and how to increase patient awareness of the importance of the health data for research)

10 Patient engagement in study development (including, refinement of study objectives, selection of study design, outcome definitions and recruitment strategy) and implementation Patient engagement in interpretation, communication and dissemination of study findings SPEAKERS Evolving Paradigm and Lessons Learned Irene Petersen, Reader in Epidemiology and Statistics at University College London & Professor of Biostatistics at Aarhus University Overview of Patient Engagement in Clinical and PE Research Patient Advocacy Perspective Derick Mitchell, CEO, The Irish Platform for Patient Organisations, Science and Industry (IPPOSI) & Member of EUPATI Overview of Patient Engagement in Clinical and PE Research Patient Perspective TBD Patient Speaker EUPATI Trainee (from Ireland) OTHER PANELISTS Cindy Girman, FISPE, President, CERobs Consulting, LLC Adjunct Professor, Department of Epidemiology, UNC Chapel Hill & Member of the Methodology Committee for PCORI Patient Advocacy Representative (TBD, from another EU country) MODERATOR Ken Hornbuckle, FISPE, Research Fellow Pharmacoepidemiology, Global Patient Safety, Eli Lilly and Company 11:30-1:00pm Lunch/Poster Session B/Exhibits Roundtable Discussions - TBA

11 ISPE Committee Meetings Open to all participants. (Lunches will be available in meeting rooms) Bylaws & Policies Committee Development Committee Education Committee Publications Committee 11:45-12:45pm 1:00-2:30pm 2:35-3:30pm Spotlight Poster Sessions CONCURRENT SESSIONS: CONTRIBUTED PAPERS ANNUAL MEETING OF ISPE MEMBERS & AWARDS CEREMONY Open to all participants. Annual Meeting of ISPE Members Awards Ceremony The Ronald D. Mann Best Article Awards 32 ND ICPE Andrew McAfee Award John Snow Award Student Awards Stanley A. Edlavitch Award & Oral Presentation Induction of ISPE Fellows Induction of New Officers & Directors 3:30-4:00pm 4:00-5:30pm 5:30-6:15pm 7:30-11:30pm Break/Posters/Exhibits CONCURRENT SESSIONS: SYMPOSIA AND WORKSHOPS ISPE Council Meetings Open to all interested participants Academic Council Government/Regulatory Council Industry/Service Providers Council Social Evening at the Guinness Storehouse

12 SUNDAY August 28, :00-4:30pm 7:30-3:30pm 7:00-8:00am 8:00-1:45pm 8:30-10:00am 10:00-10:30am 10:30-Noon Registration Speakers Ready Room Poster Session C Set-up Exhibits/Posters CONCURRENT SESSIONS: CONTRIBUTED PAPERS Break/Posters/Exhibits HOT TOPICS SESSION: Representative Sampling in Pharmacoepidemiology: A Hot Topic or Hot Air? A recent, highly publicized paper, Perils and potentials of selfselected entry to epidemiological studies and surveys, published in the Journal of the Royal Statistical Society, put forth the argument that all epidemiologic studies should be based on representative samples of a specific patient population. For example, in a study of diabetes treatments, the target population might be all adult type 2 diabetes patients in the United States, and a representative sample could be formed either by randomly selecting patients from the target population into the study or by using a different sampling method, accompanied by sampling weights to adjust estimates for non-random sampling. While representative sampling is the norm in fields such as survey research, where the focus is on estimating measures that characterize a specific population, it is almost never used in research aiming to estimate causal effects, including both randomized trials and observational studies of treatments. Some argue that without representativeness the effects estimated from such studies are applicable only to the patients directly in the study and cannot be extrapolated to other populations, rendering the research essentially useless. Under this view, most pharmacoepidemiology studies conducted to date are invalid. This contentious issue is stirring an important

13 debate in the research community, as evinced by the more than 30 comments that were published alongside the paper. This session will explore the role of representative sampling in pharmacoepidemiology from different perspectives. Dr. Poole will present background on representative sampling, its main methods, and practical issues in its application to pharmacoepidemiology, providing a pharmacoepidemiologist s viewpoint. Dr. Evans will provide a statistician s perspective, challenging several of the epidemiologists viewpoints. Dr. Kurz will share the views and experience of regulators. SPEAKERS Charlie Poole, University of North Carolina, Chapel Hill Stephen Evans, FISPE, London School of Hygiene and Tropical Medicine Xavier Kurz, European Medicines Agency MODERATOR Jessica Franklin, Harvard Medical School and Brigham and Women s Hospital Noon-1: 30pm Lunch/Poster Session C/Exhibits ISPE Board of Directors Luncheon (Meeting open to all members; check with staff if you wish to attend) 12:45-1:30pm 1:30-3:00pm 3:00-3:15pm 3:15-4:45pm 4:45-5:30pm Spotlight Poster Walks CONCURRENT SESSIONS: SYMPOSIA AND WORKSHOPS Break CONCURRENT SESSIONS: CONTRIBUTED PAPERS The Final Word Spotlight Poster Awards 2017 Mid-Year/London 2017 ICPE/Halifax

14 Adjournment of ICPE :45-6:30pm 2017 ICPE Scientific Program Committee Meeting