The Impact of COVID-19 on Early Clinical Development - What the New Landscape Will Look Like, Upcoming Webinar Hosted by Xtalks
In this free webinar, the featured speakers will discuss virology, immunology and epidemiology of COVID-19 as well as virus detection tests and anti-SARS-CoV-2 antibody tests. Attendees will learn about COVID-19 infection risk in early clinical drug development and the impact of COVID-19 on FDA, EMA and MHRA regulatory guidances.
TORONTO, June 22, 2020 /PRNewswire-PRWeb/ -- With the emergence of SARS-CoV-2, we all have 'lost our innocence' by learning that an unexpected, novel infectious agent has a dramatic and, for today's generations, unprecedented impact on lives, society, economy and as a consequence, on the domain of clinical drug development. Clearly, the world 'post-COVID-19' will be different from the world where we came from, but what impact can we expect, and what changes may last?
This webinar will start exploring clinical drug development in the setting of SARS-CoV-2 being a new entity to deal with, by addressing the questions:
- What is known about SARS-CoV-2, its epidemiology and how it compares to earlier coronaviruses? What is known about COVID-19, the unexpected variation in its clinical presentation, in adults and in children, and the short- and long-term effects?
- How can active infection with SARS-CoV-2 be reliably measured and how can previous infection be proved by measuring immune response? How can we find our way in a myriad of tests that are becoming available in a rapid response setting, with limited, if any, regulatory oversight?
- Now that SARS-CoV-2 is amongst us, how should groups proceed with early clinical development programs, including first-in-human studies, whilst minimizing risk to study participants, maximizing informative value of the study and in compliance with all rules and regulations?
- COVID-19 has pressure tested clinical drug developers and regulators, and has brought about ad-hoc changes in regulatory approaches. What COVID-19 imposed regulatory changes can be expected to be long-lasting and here to stay?
Join Radboud van Trigt, PhD, Director of Bioanalytical Science – Biomarkers, PRA Health Sciences, Gregory P. Licholai, MD, MBA, Yale School of Management, Chief Medical Officer, PRA Health Sciences and Arwa Shurrab, Senior Director, Regulatory Strategy, PRA Health Sciences in a live webinar on Monday, July 13, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit The Impact of COVID-19 on Early Clinical Development – What the New Landscape Will Look Like.
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/
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