TMF Insights from TMF Experts

Phlexglobal Webinar Series

The Importance of Contemporariness and an Approach to Mitigate Audit Findings

Thursday, December 12, 2019 | 1pm EST (10am PST)

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Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first “C” in the ALCOA-C guidance, but recent regulatory guidance 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 an attempt to address the issue of contemporariness, sponsors and contract research organizations (CROs) have relied on resource-heavy and costly time-stamping of all incoming site correspondence to start the measure — but does this address regulatory concerns?

In this free webinar, the featured speakers will explore:

  • How contemporariness can be defined in operational SOPs
  • How contemporariness can be implemented in daily operations
  • How to measure and document contemporariness
  • Ensure audit readiness with regards to contemporariness

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Featuring...

Charity-150Charity Metz Schuller
Sr. Director Regulatory Affairs
PPD

 

molly-150Molly Brock
Sr. Director, Clinical Operations
PRA Health Sciences

karen-150Karen Roy
Chief Strategy Officer
Phlexglobal

 

elvin-150Elvin Thalund
Director, Industry Strategy
Oracle Health Sciences

 

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