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Thursday, June 18 • 5:00pm - 6:00pm
#546 OD: ON DEMAND - Quality Oversight of Pharmacovigilance Processes

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Component Type: Session
Level: Intermediate

Oversight is essential to assure that pharmacovigilance processes remain in a state of control, responsibilities are being performed as assigned, and that the quality management system supporting pharmacovigilance is effective. Effective oversight is an ongoing monitoring activity that looks at processes end-to-end, verifying that they are designed well and executed in a consistent and systematic way. Feedback loops from oversight activities are essential to drive continuous improvement. Oversight approaches must advance to keep up with the ever-increasing complexity of pharmacovigilance activities as well as the new opportunities presented by technology. Quality assurance auditing, the classic oversight tool, is evolving to leverage technology to be both more effective and efficient. Continuous evaluation of process performance, end-to-end through communication of safety information via labeling, is critical to assuring the correct linkages and that the process is always completed as expected. Assessing the external landscape and using the intelligence obtained provides and important way to check that the pharmacovigilance system is complete and stanards are aligned with current expectations. This session will cover how different approaches can contribute to a robust oversight model across the continuum of pharmacovigilance activities.

Learning Objectives

Recognize innovations in quality oversight through remote audit techniques; Describe how regulatory intelligence can be leveraged as a strategic compliance advantage; Identify how the Company Core Data Sheet (CCDS) can be manage to assure that safety information is consistent and complete globally.

Chair

David William Fryrear, MS

Speaker

Robust Regulatory Intelligence: A First Step Towards Compliance
Marina Suvakov, MS

Quality Oversight of Pharmacovigilance Processes by Technology Driven Remote Audits
Gaurav Shah, PharmD, PhD

CCDS or Local Labeling, a Chicken-and-Egg Situation? The Dilemma of the Product Reference Information Across the Consistency
Luca Cariolato, PhD, MSc



Speakers
avatar for David Fryrear

David Fryrear

Executive Vice President and Head of Quality Assurance, Astellas, United States
David Fryrear, M.S., is Executive Vice President and Head of the Quality Assurance for Astellas and has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development, and... Read More →
avatar for Marina Suvakov

Marina Suvakov

Director, GPV, Otsuka
A PV professional with over 12 years’ experience ranging from start up’s to big pharma. I graduated with a degree in Medical Biochemistry and have a Masters in Pharmaceutical Sciences. I have spent time working in Switzerland, the USA and the UK and am passionate about the work... Read More →
LC

Luca Cariolato

Senior Safety Scientist, UBC
I had obtained my master in pharmaceutical biotechnology in 2004 and my Ph.D. in Life Sciences in 2011. After a postdoc in cancer immunology, I joined UBC in 2013, where I started my career in Pharmacovigilance. For more than five years, I am involved in medical writing, in particular... Read More →
avatar for Gaurav Shah

Gaurav Shah

Vice President and Head, Global Quality and Compliance, APCER Life Sciences
Gaurav Shah (Mpharm, MBA, PhD) is a dynamic professional with over 16+ years of cumulative experience in Pharma and clinical service industries. He has vast experience as a Global Auditor and Project Director. Gaurav has extensive experience in undertaking GVP/GCP Inspections from... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044