In this free webinar, learn how the recent FDA & EMA regulations are helping advance and enhance electronic clinical outcome assessments (eCOA/ePRO). Attendees will gain an understanding how these new guidances have the potential to enhance and accelerate the use of eCOA/ePRO in clinical trials. The featured speakers will discuss the nuances of submission requirements for European Ethics Committees/IRB.
TORONTO, July 11, 2023 /PRNewswire-PRWeb/ -- In an effort to help advance and enhance electronic clinical outcome assessments (eCOA/ePRO), four esteemed professionals from the Clario's eCOA Science team will be conducting a free webinar on recent FDA & EMA regulations.
The past six months have seen the release of new guidance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regarding ethics committee (EC) submission, decentralized trials, patient-focused drug development and electronic systems and computerized systems. These guidelines, though some are still in draft format, are indirectly aiding in the progress and enhancement of the use of eCOA, such as maintaining data quality in decentralized trials or electronic submission to ethics committees.
The webinar will include a comprehensive overview of the new/changed guidances, an exploration of how the new guidance could potentially advance and enhance the use of eCOA/ePRO, and a deeper look into the intricacies of submission requirements for European Ethics Committees/IRB.
The presenters for the webinar are the following experts from Clario: Bryan McDowell, MSc, MBA, Vice President, eCOA Clinical Science & Consulting; Dr. Kelly Dumais, PhD, Director, eCOA Science and Consulting; Dr. Valdo Arnera, MD, Medical Scientific Advisor and General Manager, Geneva Office; and Dr. Thomas Moll, PhD, MBA, Scientific Advisor.
Clario is a global data and technology company that helps to minimize risk in clinical trials, leading the way in eCOA Science and Consulting. Clario has teamed up with Xtalks to offer this webinar, as part of their mutual commitment to provide valuable insights into the life sciences industry.
The live webinar, "How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA/ePRO)," is scheduled for Wednesday, July 26, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA/ePRO).
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Vera Kovacevic
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Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com
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