SOURCE: Xtalks

Xtalks Webinars

November 28, 2016 07:30 ET

Upcoming Webinar to Examine Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites

TORONTO, ON--(Marketwired - November 28, 2016) - On Tuesday, December 13, 2016, Xtalks will host a complimentary webinar featuring presenters Andrew Mitchell, Life Sciences Lead at Intralinks and Dan Sfera, owner of multiple investigator sites, a CRA academy and renowned for his blog, The Clinical Trials Guru. This webinar will focus on how Investigator Sites are preparing for ICH-GCP E6(R2) especially with regards to remote monitoring, sponsor oversight and a risk-based approach to quality management at investigator sites.

For the first time in two decades, significant updates to the international guideline for clinical trials will soon be released. Slated for November 2016, the revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonisation (ICH) has major implication for stakeholders and reflects the industry's growing emphasis on risk-based quality management supported by expanded use of innovative technologies.

This guideline, known as ICH-GCP E6(R2), highlights the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for increased efficiency in quality management. Specifically, describing quality management as multi-faceted, with emphasis on re-imagining protocol design to minimize complexity, unnecessary procedures and related data collection key to better decision making.

Regulatory implementation is expected in mid-2017 and will be felt around the world with initial scope including both Canada and Switzerland beyond the tripartite of the EU, Japan and US.

Join this webinar to find out how this applies at investigator sites and hear directly from Dan Sfera about how sites are already today using Intralinks in making these process changes possible along with why it's critical for sites to embrace digital transformation to improve their efficiencies and facilitate remote monitoring.

For more information or to register for this free webinar visit: Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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