DIA
Drug Information Association Logo
« Back to Listing

Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2)

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 17, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
295

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2)

Chair(s):
Ann Meeker-O'Connell, MS
Senior Director, QA Clinical Strategy Team Lead
Janssen, United States

Description:
Emerging technologies have the potential to dramatically increase the efficiency and quality of clinical trials. Significant attention has been given to technology that may benefit both sponsor and investigator sites, such as electronic data capture (EDC) systems and eSource systems; these are technologies that may streamline data collection at the site-level, change data quality control paradigms, and provide sponsors with real-time insight into the accumulating data about an investigational product. This session will turn the focus to emerging technologies that may facilitate patient participation in clinical trials, such as electronic informed consent forms (eICF) and electronic patient reported outcome (ePRO) tools. FDA, industry, and patient advocate speakers will discuss the potential benefits of adopting patient-centric technology, the potential challenges in implementation, as well as compliance considerations in meeting applicable laws and regulations.

Part 1 will take place on Tuesday at 1:30 pm (Session #271).

Learning Objective(s):
Discuss emerging technologies including the potential benefits of adopting patient-centric technology; Explain the potential challenges in implementation as well as compliance considerations in meeting applicable laws and regulations.

Presentation(s) & Speaker(s):
Regulatory Perspective
Sean Y. Kassim, PhD
Acting Office Director, OSI, OC, CDER
FDA, United States

Industry Perspective
Coleen M. Glessner
Vice President, Clinical Trial Process and Quality
Pfizer Inc, United States

Patient Perspective
Marcia K. Horn, JD
President and Chief Executive Officer
International Cancer Advocacy Network (ICAN), United States