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.
TORONTO (PRWEB) November 20, 2019
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.
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