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Sunday, June 24, 8:30 am - 12:00 pm
Tutorial 20: Overview of the Japan Regulatory Environment: Overview of the Organization, Processes, Systems, and Changes Affecting Pharmaceutical Development
Alberto Grignolo, PhD, Corporate Vice President, Global Strategy and Services
Sunday, June 24, 8:30 am - 12:00 pm
Tutorial 24: A Device Primer: 510(k)s, PMAs, IDEs
Barry Sall, Principal Consultant
Monday, June 25, 10:00 am - 11:30 am
Maximizing Supply Chain Efficiency During the Course of a Study Through Use of Systematic Monitoring
Andrey Gurachevsky, Associate Clinical Logistics Leader
Monday, June 25, 10:00 am - 11:30 am
IVDs as companion diagnostics in personalized medicine; A medical device perspective
Barry Sall, Principal Consultant
Monday, June 25, 1:30 pm - 3:00 pm
The Stare of the 510(k) pathway post-IOM Report
Barry Sall, Principal Consultant
Tuesday, June 26, 10:00 am - 11:30 am
Optimizing Project Performance in a Matrix Environment: CRO Perspective in Asia
JingPing Yeo, Senior Portfolio Director
Tuesday, June 26, 1:30 pm - 3:00 pm
Collaborative Partnerships in Drug Development: A CRO CEO Roundtable Discussion
Josef von Rickenbach, Chairman and CEO
Tuesday, June 26, 1:30 pm - 3:00 pm
Implementing Bayesian Response Adaptive Trials
Bill Byrom, Senior Director, Product Strategy
Wednesday, June 27, 10:00 am - 11:30 am
CTA Requirements in Europe
Beate Roder, Director
Thursday, June 28, 9:00 am - 10:30 am
The vital role of patient-reported data for monitoring study compliance and overall performance
Session Chair: Keith Wenzel, Senior Director, Global Alliances
Thursday, June 28, 10:45 am - 12:15 pm
The holy grail of CTMS – paying investigators on clean data
John Humphreys, Product Manager
Thursday, June 28, 9:00 am - 10:30 am
Nonclinical and Translational Development/Early Phase Clinical Development
Session Chair: Cecil Nick, FTOPRA, Vice President (Technical)
Please visit PAREXEL and Perceptive Informatics in booths 2224 & 2125 in the exhibit hall.
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