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New Options for Avoiding a Dedicated TQT Study -- The Impact of the New ICH E14/S7B Revisions, Upcoming Webinar Hosted by Xtalks


News provided by

Xtalks

Sep 12, 2022, 08:30 ET

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In this free webinar, learn about the recent changes to ICH E14 & S7B revisions. The featured speakers will discuss the practical implications of these ICH E14 changes and the advantages of new pathways for drug developers. From a clinical point of view, attendees will understand S7B revisions and how it will need to be reviewed with in vitro and in vivo cardiovascular (CV) safety data.

TORONTO, September 12, 2022 /PRNewswire-PRWeb/ -- In this webinar, the featured speakers will be discussing the impact of the new ICH E14 and S7B revisions and how they impact clinical trials. Dr. Darpo will be discussing the new E14 material and will share the practical implications and use cases. Dr. Kleiman will discuss the S7B changes from the view of a clinician, rather than as a nonclinical safety pharmacologist. They will then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.

Join this webinar to understand the recent changes to ICH E14 & S7B revisions.

They will then share their impressions on the new opportunities that these revisions provide for drug development, as well as some thoughts on the as yet unresolved issues that will only become clarified over the next few years as regulators become more familiar with nonclinical data.

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Join experts from Clario, Robert Kleiman, MD, Vice President, Cardiology & Chief Medical Officer; and Borje Darpo, MD, PhD, Chief Scientific Advisor, Cardiac Safety, for the live webinar on Friday, September 30, 2022, at 11am EDT (4pm BST/UK).

For more information, or to register for this event, visit New Options for Avoiding a Dedicated TQT Study — The Impact of the New ICH E14/S7B Revisions.

ABOUT CLARIO

Clario is a leading technology company that generates the richest clinical evidence in the industry for our pharmaceutical, biotech and medical device partners. Across decentralised and site-based trials, our deep scientific expertise, global scale and the broadest endpoint technology platform in the industry allows our partners to transform lives. Clario's Trial Anywhere™ solutions have been powering hybrid and decentralized clinical trials (DCT) for over 20 years, enabling sponsors to collect high-quality endpoint data from any modality or location, all while improving the patient experience and diversity. Clario has the only technology platform that combines eCOA, cardiac safety, medical imaging, precision motion, and respiratory endpoints. With 30 facilities in nine countries, Clario's global team of science, technology and operational experts has helped deliver over 19,000 trials and 870 regulatory for over 5m patients in 120 countries. Our innovation has been transforming clinical trials for 50 years.

For more information, go to Clario.com or follow us on LinkedIn and Twitter.

Clario Media Contact
Duncan Cantor
Sr. Director, Corporate Communications
[email protected]

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, 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.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

Media Contact

Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, [email protected]

SOURCE Xtalks

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