The Importance of Contemporariness and an Approach to Mitigate Audit Findings, Upcoming Webinar Hosted by Xtalks

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Contemporariness in clinical operations is not new for professionals striving for compliance with Good Clinical Practice, however, new guidance from the MHRA and EMA have created new challenges and uncertainty within the industry. Contemporariness not only presents a challenge to the trial master file, but it also affects multi-country studies spanning multiple regulatory agencies. In this free webinar, learn how contemporariness can be implemented, measured and documented to ensure audit readiness.

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The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.

Contemporariness is an important component of clinical operations that is outlined in global regulatory guidance. However, recent changes from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) has created new challenges and uncertainty within the industry with regard to its implementation in a trial master file.

Contemporariness is not just isolated to the trial master file; it presents a problem to multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.

In a live webinar on Thursday, December 12, 2019 at 1pm EST, expert speakers will discuss contemporariness in daily operations and describe ways for sponsors and contract research organizations (CROs) to be audit-ready.

Featured speakers include:

  • Charity Metz Schuller, Sr. Director Regulatory Affairs, PPD
  • Molly Brock, Sr. Director, Clinical Operations, PRA Health Sciences
  • Karen Roy, Chief Strategy Officer, Phlexglobal
  • Elvin Thalund, Director, Industry Strategy, Oracle Health Sciences

This webinar will include a live Q&A session with the speakers.

For more information or to register for this event, visit The Importance of Contemporariness and an Approach to Mitigate Audit Findings.

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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Candice Tang
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