市販後調査（第3b相〜第4相）および登録管理

ELECTRONIC HEALTH RECORDS AND CLINICAL TRIALS
-電子健康記録と治験-

Shared session with Electronic Data in Clinical Trials

Clinical Innovation and Pfizer's Virtual Trial

Craig Lipset, Head, Clinical Innovation, Pfizer Worldwide Research & Development

Beyond the Primary Endpoint: Optimizing Learning from Clinical Trials

Eric Perakslis, Ph.D., Vice President, Research & Development IT, Johnson & Johnson Pharmaceuticals Research and Development

A Full System Approach to Electronic Data and Integration with the Patients' EHR

John Parkinson, Ph.D., Head, GPRD, MHRA Medicines & Healthcare Products Regulatory Agency

REGISTRIES AND OBSERVATIONAL STUDIES
-登録および観察調査-

Current Challenges in Comparative Effectiveness Research (CER) and Future Directions in Registries and Observational Studies

Charlie Barr, M.D., Medical Director and Head of Patient Registries, Medical Affairs, Genentech (tentative)

Strategic and Operational Challenges in Late Phase Research and Observational Studies

Carmen Bozic, M.D., Senior Vice President and Global Head, Safety and Benefit-Risk Management, Biogen Idec

Are They Different?: PASS and Registries in the EU and US

Eleanor Segal, M.D., former Vice President & Head, Global Drug Safety, Actelion; Independent Biopharmaceutical Consultant

Orphan Disease Registries and Post-Marketing Commitments

Emma James, Senior Project Manager, Evidence-Based Medicine Center of Excellence, Genzyme

BALANCING POST-MARKETING REQUIREMENTS
OF IN-HOUSE AND POLICY STAKEHOLDERS
-社内および政策ステークホルダーの市販後要件調整-

Balancing the Post-Marketing Requirements of Key Stakeholders

Christopher Milne, Ph.D., Professor, Associate Director, Center for the Study of Drug Development, Tufts University Medical School

Multiple Stakeholders: Challenges and Best Practices in Managing Program Scope in Long Term, Observational Registry Programs

Catherine Koepper, Director, Global Registry Operations, Evidence Based Medicine, Genzyme, a Sanofi Company

Global Regulatory Strategy for Phase III/IV Post-marketing Studies

Helen Edelberg, M.D., Vice President, Regulatory Affairs (Consultant), Aptalis Pharma

Overcoming Key Challenges in Post-Marketing Commitments

Sean Zhao, M.D., Ph.D., Vice President, Global Safety, Amylin Pharmaceuticals, Inc.

OPERATIONAL CHALLENGES IN PHASE IIIb-IV
-第3b相〜第4相における業務上の課題-

Shared session with Global Site Selection, Feasibility Assessment, Operations and Site Management

Sponsored by
When Enrollment is the True Priority, Which Feasibility, Site Selection and Site Support Methods Apply Equally in Registration and Post-Approval Studies?

Jaime Cohen, Strategic Planning, BBK Worldwide

Unique Challenges of Site Management, Project Management and Ops in Post-Marketing Studies

Speaker to be Announced

Sponsored by
Is There Patient Recruitment in a Post-Marketing Study?

Tess Drahzal, Director, Patient Recruitment Strategies, United BioSource Corporation (UBC)

Operational and Organizational Challenges of Post-Marketing Requirements

Speaker to be Announced

UTILIZATION OF PATIENT-LEVEL DATA/PATIENT
REPORTED OUTCOMES (PROs) IN TRIALS
-治験における患者レベルのデータ／患者報告アウトカム（PRO）の利用-

Creating a Novel PRO to Measure Patient Perspective

Elsie Matthews, Director, Global Data Operations, Bristol-Myers Squibb Co.

Generate, Analyze and Interpret PRO Data to Support Drug Development and Achieve Commercial Objectives

Speaker to be Announced

Maximizing the Use of IT and Tools for Registries and Non-Interventional Observational Studies

Speaker to be Announced

BREAKOUT DISCUSSION GROUPS -分科会ディスカッショングループ- Interactive Breakout Discussion Groups: Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest to them and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Topics may include: Properly designing and managing patient registries to produce a wealth of valuable data in a cost-effective manner Effective tools for registries and non-interventional observational studies: Leveraging IT and tools for improved data capture, tracking, reviewing and processing Risk-based monitoring: Is statistical monitoring sufficient for an observational study with sufficient power to provide for good statistical analysis? How do I choose the right partner to support my study? Overcoming recruitment challenges: Recruiting patients to join studies that are focused on an already approved drug Outcomes research and disease management: Understanding the role and management of health economic studies Site selection and site management for an observational study: How to do proper site selection and management in Phase III vs. IV Optimizing use and management of patient-reported outcomes (PROs) in clinical research: When are they most useful and what are current limitations; what is next generation capabilities in PRO Meeting regulatory requirements for post-authorization in various countries and regions Safety or marketing...do you have to choose?

お勧めの月曜午後のショートコース EMR/EHRs: Utilization of Electronic Health Record (EHR) Data for Clinical Research -EMR/EHR：臨床研究のための電子健康記録（EHR）データの活用-