全球治療效驗實施設施之選定、可實現的評估、業務、設施管理

COUNTRY SELECTION, SITE SELECTION AND STUDY PLANNING CONSIDERATIONS
-國家選定、治療效驗實施設施選定和治療效驗計劃檢討-

Optimizing Protocol Development and Site Selection: Getting it Right in the Beginning

Joseph Kim, M.B.A., Clinical Operations Director, Shire

Driving Innovation in Study Start-Up: Optimizing Site Performance through Evidence-Based Site Selection

Daphne Van, Global Trial Optimisation Manager, Centre for Project & Study Excellence, GlaxoSmithKline

Co-Presentation

Modeling the Country and Site Selection for Shortening the Clinical Development Timeline

Feng Li, Manager, Stakeholders Office, sanofi-aventis

Jaap Hoek, Vice President, Clinical Sciences & Operations, sanofi-aventis

OPTIMIZING THE FEASIBILITY PROCESS
-可實現評價過程最適化-

Importance of Site Feasibility Process: First Critical Step to a Successful Study Outcome

Sudeesh Tantry, Ph.D., Associate Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc.

Co-Presentation

A Collaborative Approach Looking at Feasibility: Plans to Reduce Time, Cost and Percentage of Non-Active Sites from Both the Sponsor and Site Perspective

Nye Pelton, Clinical Operations Portfolio Management, (COPM)USMD, Eli Lilly

Deena Bernstein, Director, Clinical Research, Sheridan Clinical Research

OVERCOMING CHALLENGES IN CLINICAL OPERATIONS,
SITE MANAGEMENT AND RETENTION
-克服治療效驗業務、治療效驗實施設施管理及確保的課題-

Understanding and Planning for the Increased Incidence of Non-Compliant Patients, Inappropriate Patients and Financially Motivated Patients

Ellis Wilson, Senior Director, Project Coordination, AstraZeneca

Improving Performance and Relationships with International Investigative Sites: Evaluating Relationships with Sponsors and CROs and Vice Versa

Joan Chambers, COO, CenterWatch

Sponsored by
TalkTitle to Be Announced

Trifecta (Speaker to be Announced)

Improving Operational Efficiencies within the Sponsor Organization: A Device Perspective

Kathi Durdon, Manager, Clinical Operations, Welch Allyn

OPERATIONAL CHALLENGES IN PHASE IIIb-IV
-第3b相∼第4相業務上的課題-

Shared Session with Managing Post-Marketing Studies (Phase IIIb-IV) and Registries

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, Associate Director, Patient and Physician Services, United BioSource Corporation (UBC)

Operational and Organizational Challenges of Post-Marketing Requirements

Speaker to be Announced

分科委員會discussion group 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: Site selection and study planning considerations: Understanding regional issues, regulatory landscapes, and local ethical processes Optimizing country selection: Strategies for positioning trials for success using a global footprint Optimizing the site feasibility process: Improving global site feasibility assessment to identify sites that will recruit on time and within budget Cost-effective techniques for finding high performing sites: High-tech and low-tech solutions to avoid uninterested and low enrolling parties Overcoming challenges in clinical operations and site management: Linking sponsors, service providers and investigative sites and positioning sites for success by anticipating their needs Improving operational efficiencies in Site, CRO, and sponsor interactions: Implementing strategic relationships and other forms of partnerships Driving innovation in study start-up: Optimizing processes, training leaders and leveraging technology

推薦星期一下午的短期課程 Social Media and Mobile Technology in Supporting Patients in Studies and Registries -為了在治療效驗•登記時支援接受試驗者的社會媒體和行動技術-