Continuing Education credits are not available for the archived offering.

This archived webinar is available for purchase through February 1, 2016.
Broadcast time: 1 hour 25 minutes

Series Overview:
Providing greater access to clinical trial data has a number of benefits including facilitating further research to advance medical science and improve patient care. To deliver these benefits and respond to calls for greater transparency regulators, industry professionals, and academics have looked to create and frameworks for data sharing. These initiatives raise questions around appropriate mechanisms for improved openness and transparency, new data-use, privacy, and operational and infrastructure challenges.

DIA is presenting a three-part webinar series on Clinical Trial Transparency, which will begin with “Paving the Way for Greater Access to Data” a discussion focused on the benefits and concerns surrounding  greater access to clinical trial data such as how to facilitate further research and address concerns around privacy and legitimate re-use..  In our second installment, the focus will shift to “Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy Groups”.  This discussion will place an emphasis on the opportunities and challenges to providing access to data from clinical trials conducted outside of industry. This will include the potential for developing a bridge between academia and industry frameworks for data access.   Finally, this series will conclude with, “Understanding the Legislative Landscape: Regulatory Updates from the FDA, EMA, and Health Canada”,   taking a closer look at US, European, and Canadian legislative requirements to include perspectives from the FDA, EMA, and Health Canada on current and future initiatives.

Part 3 Overview:
In addition to efforts made by trial sponsors to open up access to data, international legislators have focused on policies to progress greater disclosure of information. In recent years, the FDA, EMA, and Health Canada have considered how policy could be developed further to expand access to trial data and documents. This third and final webinar within the Clinical Trials Transparency series will focus on the US, European, and Canadian legislative requirements to include perspectives from the FDA, EMA and Health Canada on current and potential future initiatives.

Featured Topics

• FDA Policy and Perspective on Data Sharing
• EMA Policy and Perspective on Data Sharing
• Health Canada Policy and Perspective on Data Sharing

View Series Part 1 and Part 2

Part 1 - Paving the Way for Greater Access to Data

Part 2 - Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy