PROficiency 2010 Webinar Series and Conference

invivodata’s PROficiency 2010: Educational Series on Patient Reported Outcomes

pro-fi'-cien-cy:  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 and PRO conference. These sessions will be presented by leading industry experts and will offer you the opportunity to participate in live Q&A sessions.

UPCOMING EVENTS IN SERIES

webinarHow do you know your drug works?  The Role of Patient Reported Outcomes (PROs) in Drug Development Strategy

Date: 
Thursday, September 30 at 11:00 AM Eastern 

In this session, Dr. Paty will discuss:

  • How PRO instrument selection is strategic in drug development
  • Essential considerations in developing a successful PRO strategy
  • How your PRO measurement strategy can help differentiate your product

Presented By:
Dr. Jean Paty, Founder and Chief Regulatory and Scientific Advisor, invivodata, inc.

Click here to register for this webinar

PAST EVENTS IN SERIES

ePRO Regulatory Inspection Expectations - Be ready, be agile, be precise!

Origianal Date: June 24, 2010

Based on real-world ePRO experiences with regulatory inspectors, this webinar will identify the inspectors’ key areas of interest during an ePRO inspection. We will highlight a case study of an inspection along with recommendations on preparing for and supporting site and system inspections.

Presented By:
Gretchen Craig, Manager of Quality Assurance, invivodata, inc.
Raymond Panas, PhD, Director of International Clinical Development, Sucampo Pharmaceuticals

Click here to register for the replay of the ePRO Regulatory webinar

Implementing PROs in Clinical Trials

Original Date:  April 13, 2010
This webinar is the third part of invivodata's 2010 PROficiency webinar series which focuses on the FDA's final PRO Guidance.  In this session, Dr. Jean Paty will review specific considerations that biopharma researchers need to keep in mind when implementing PROs in clinical trials. The webinar will focus on specific elements of PRO trial design, including blinding and randomization, missing data, and clinical interpretation of the PRO data.  This will be followed by a detailed discussion on methods of PRO administration in the context of trial execution. 

Click here to register for the Implementing PROs in Clinical Trials webinar replay

ePRO Industry Best Practice and Regulatory Considerations: An Update on Issues that Affect your Clinical Trials

Original Date:  March 23 & March 25, 2010
Two important documents that directly impact the ePRO arena have recently been released: ePRO: Electronic Solutions for Patient Reported and the FDA's final guidance on the use of patient-reported outcomes for labeling claims. In this seminar, scientists from invivodata and Perceptive Informatics will focus on several important ePRO topics discussed in these documents, including measurement equivalence for ePRO, reducing sample size via ePRO data integrity, migrating clinician instruments to ePRO, and user interface design issues for ePRO. 

Click here to register for the ePRO best practices webinar replay

How to Effectively Incorporate PROs into Clinical Trials

Original Date:  March 4, 2010
In this webinar, PRO Consulting's Dr. Jean Paty will focus on specific implications of the final PRO Guidance and what it means for your clinical development program, including the design of your PRO measures. 

Register now for Effectively Incorporating PROs webinar replay

Final PRO Guidance Insight from invivodata

Original Date:  January 19, 2010
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.

Download the Final PRO Guidance Insight from invivodata Webinar Replay

eDiaries: From Clinical Proof-of-Concept Through to NDA Approval

Original Date:  December 3, 2009
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 lessons learned during clinical development and the NDA submission and approval process.

Download eDiaries: From Clinical Proof-of-Concept Through to NDA Approval

Presented by:  Michael Hufford, PhD, Vice President, Corporate Development, Cypress Bioscience, Inc.

Supporting Regulatory Submissions and Inspections: the ePRO Perspective

Original Date:  October 22, 2009
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.

Download Supporting Regulatory Submissions and Inspections Webinar Replay

Presented by:  Raymond Panas, PhD, MPH, Director of International Clinical Development,Sucampo Pharmaceuticals
Gretchen Craig, Manager of Quality Assurance, invivodata, inc.

 Download information about invivodata's ePRO Inspection Support

Developing PROs: Common Pitfalls & Recent Experiences

Original Date:  September 10, 2009 
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.

Download Developing PROs: Common Pitfalls & Recent Experiences Webinar Replay.  

Presented by:  John Powers, III MD, FACP, FIDS, Clinical Assistant Professor of Medicine, School of Medicine, George Washington University & University of Maryland (formerly of FDA)

Case Study: Developing and Acting Upon a Conceptual Model in the Context of a Global Drug Development Program

Original Date:  July 30, 2009 
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. 

 Download Conceptual Model Webinar Replay.

Presented by:  Betsy Williams, PhD, Senior Director for Product Development, ePRO, Dainippon Sumitomo Pharma America, Inc. (DSP-A)

Improving Measure Sensitivity in Early Stage Research

Original Date:  June 18, 2009 
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.

Download Measure Sensitivity Webinar Replay

Presented by: Saul Shiffman, PhD, Chief Science Officer, invivodata, inc.

Sign up below for ePRO Pulse™, invivodata's industry newsletter