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Pharmacovigilance Reporting and Quality
Session Chair(s)
Matthew Krumrai
Director, Clinical Quality Assurance
AbbVie, United States
Expectations for quality and compliance in pharmacovigilance process and systems continues to rise Having a comprehensive quality system, including a robust CAPA process, is now essential for both good quality management and to drive continuous improvement. CAPA is also a focus of inspection by many key regulatory authorities.
Meanwhile, the global expansion pharmacovigilance and evolving safety requirements continue to add complexity, increasing the challenge of executing consistently in a compliant manner. This is exemplified in the challenges presented by assuring proper distribution of safety report to the right person at the right time as well as in the management of Reference Safety Information (RSI) and Investigator's Brochures (IBs) according to the EU requirements.
This session will explore these hot topics in pharmacovigilance quality and compliance and provide insight on current expectations.
Learning Objective : o Trending of audit findings and how to detect systemic issues before the proliferation of conflicting or redundant CAPA o Constructing CAPA hygiene – how to develop a CAPA at the right level of detail, with reasonable timelines and root cause classifications o Defining the difference between a CAPA and a correction o Providing tips for managing cross-functional ownership of CAPA
Speaker(s)
CAPAs, CAPAs Everywhere: How Effective are They and How Can they be Improved?
Kelly Traverso
Deloitte, United States
Vice President - R&D Business Development and Sales
Optimizing Global Safety Reporting in Clinical Trials Using Local Laws
Steven Beales
WIRB-Copernicus Group (WCG), United States
Senior Vice President, Scientific and Regulatory Review
Global Clinical Trials and the Complexities of Reference Safety Information (RSI)
Andrea Best, DO, MPH
AbbVie, United States
Executive Medical Director
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