ePROficiency Webinar Series
ePROficiency Webinar Series
invivodata’s ePROficiency Webinar Series on Patient Reported Outcomes
Proficiency: the advancement of knowledge or skill
Take advantage of the ability to advance your knowledge of patient reported outcomes measures by attending invivodata's upcoming complimentary educational webinars. These sessions will be presented by leading industry experts and will offer you the opportunity to participate in live Q&A sessions.
Final PRO Guidance Insight from invivodata
Based on regulatory guidance, invivodata and our PRO Consultants will provide analysis and insight into the final PRO Guidance to help you understand what you need to do differently moving forward in your clinical research programs.
Tuesday, January 19, 2010
Jean Paty, PhD, Founder and Senior Vice President, Scientific, Quality and Regulatory Affairs
invivodata, inc.
Download the Final PRO Guidance Insight from invivodata Webinar Replay
Improving Measure Sensitivity in Early Stage Research
Based on regulatory guidance, Phase II is the appropriate time to develop and validate PRO measures, making ePRO a logical fit earlier in the clinical development lifecycle. This session will cover the advantages of incorporating electronic PRO capture methods in Phase II or early stage development studies.
Original Date: Thursday, June 18
Saul Shiffman, PhD, Chief Science Officer
invivodata, inc.
Download Measure Sensitivity Webinar Replay
Case Study: Developing and Acting Upon a Conceptual Model in the Context of a Global Drug Development Program
This case study will discuss a project that was ongoing when the draft PRO guidance was published. We will review the process that was followed for development of a conceptual model, starting with a global workshop, and share how the conceptual model has been implemented for this development program.
Original Date: Thursday, July 30
Betsy Williams, PhD, Senior Director for Product Development, ePRO
Dainippon Sumitomo Pharma America, Inc. (DSP-A)
Download Conceptual Model Webinar Replay
Developing PROs: Common Pitfalls & Recent Experiences
The speaker will discuss some of the common pitfalls in developing PROs based on experiences over the last 3 years since the release of the guidance. Some examples will include: 1) lack of focus regarding specific claims in labeling, 2) getting in the game late - deciding to use a PRO late in the development of a medical intervention, 3) challenges in using previously published PROs starting with issues in content validity, and 4) approaches to determining the minimally important difference for a PRO.
Original Date: Thursday, September 10
John Powers, III MD, FACP, FIDS, Clinical Assistant Professor of Medicine, School of Medicine
George Washington University & University of Maryland (formerly of FDA)
Download Developing PROs: Common Pitfalls & Recent Experiences Webinar Replay
Supporting Regulatory Submissions and Inspections: the ePRO Perspective
This session will review the key areas of focus for ePRO submissions and inspections from the site, the sponsor, and the ePRO partner perspective. Topics will include lessons learned on how to successfully prepare for and participate in ePRO inspections at the site-level and sponsor-level based on real experience and how to collaborate with an ePRO partner to support the inquiries.
Original Date: Thursday, October 22 - 10 AM EST
Raymond Panas, PhD, MPH, Director of International Clinical Development
Sucampo Pharmaceuticals
Gretchen Craig, Manager of Quality Assurance
invivodata, inc.
Download Supporting Regulatory Submissions and Inspections Webinar Replay
Download information about invivodata's ePRO Inspection Support
eDiaries: From Clinical Proof-of-Concept Through to NDA Approval
Clinical, operational, and regulatory issues involved in the use of eDiaries in the Phase II and III trials will be discussed, with an emphasis on les¬sons learned during clinical development and the NDA submission and approval process.
Original Date: Thursday, December 3
Michael Hufford, PhD, Vice President, Corporate Development
Cypress Bioscience, inc.
Download eDiaries: From Clinical Proof-of-Concept Through to NDA Approval