Pharmacovigilance (PV) is the science and process of monitoring the safety of medicines, taking action to reduce the risks and increase the benefits of medicines to patients and maintaining regulatory compliance. As biopharmaceutical companies increasingly seek to achieve global patient access, there is a need to develop PV procedures and systems that go beyond the strict confines of safety signal detection to provide for proactive benefit/risk management and optimized oversight.
In adapting to this changing landscape, biopharma PV capabilities must:
- Establish a process that ensures global consistency and compliance while maintaining flexibility to support local market requirements
- Support a wide variety of regulatory authority timelines and requirements, as well as partnership agreements
- Monitor quality and compliance, in near real-time, to address potential issues as quickly as they are identified
- Bridge data access and analytics between study-based safety and post-marketing safety to provide a holistic view of a product’s safety profile
- Incorporate ongoing learning and training to ensure staff are current on changing regulatory requirements and commitments
Technology is a key enabler for development of a global adverse event (AE) processing and reporting strategy. While commercially available software can effectively provide essential AE processing and reporting capabilities, there is an increasing need for the incorporation of technology integration, reporting and analytical components to deliver optimal outcomes for patients.
In this webinar, Quintiles’ experts will discuss guidance and best practices to help you:
- Create analytics and dashboards to monitor and track the quality and compliance of case processing
- Leverage operational and case processing data to maintain proper case routing, staff performance and efficiencies
- Track and manage partnership agreements to ensure reporting and inclusion commitments are maintained
- Contribute to the larger product development process and strategy with integrated safety data visibility
Improve your probability of success. Join the conversation by registering today.
Brian Guza, VP, Head of Infosario Safety, Quintiles
Brian Guza is a Vice President with a proven track record of successfully growing and developing large groups of IT professionals. Brian has over twenty five years of professional experience, with concentrations in IT Management, Pharmaceutical R&D, Pharmacovigilance, Business Process Outsourcing, and Financial Accountability. As Director, Senior Director, and Vice President of Quintiles IT, Brian transformed a 30-person internally focused IT organization into a 200-person professional services delivery firm with worldwide development and delivery capabilities on three continents. As Program Manager and Director at Johnson and Johnson, Brian was instrumental in transforming antiquated Pharmacovigilance IT systems into next-generation technologies and processes.
Brian holds a Bachelor of Science in Computer Information Systems from Kings College in Pennsylvania.
Brian currently lives in Wake Forest, North Carolina with his wife and two college-age children. Prior to 2011, Brian lived and worked in the Pennsylvania/New Jersey areas.
Annette Williams , Senior Director, Pharmacovigilance Services, Lifecycle Safety, Quintiles
Annette is responsible for leading the Pharmacovigilance Services (PV) team, which provides comprehensive project management oversight, adverse event case processing, Qualified Persons of Pharmacovigilance (QPPV) services and Safety Systems support to contracted clients. Annette joined Quintiles in late 2011 and led the establishment of Customer Safety Services, a team dedicated to the development and management of innovative drug safety solutions designed to address ever-changing global regulatory requirements. Annette is a member of Quintiles’ Lifecycle Safety’s Governance Committee which provides executive leadership and decision making for all of Lifecycle Safety.
Ms. Williams has more than 25 years of experience in both the clinical and commercial divisions of the Pharmaceutical sector, including Safety leadership. Ms. Williams provides a unique perspective to the drug safety space, through the building and scaling of outsourced safety solutions which deliver unprecedented levels of efficiency, compliance and quality, process optimization and personnel development.
Previously, Ms. Williams was Senior VP Operations, Drug Safety Alliance, Inc and has held positions with Teamm Pharmaceuticals, DAW Communications, and Glaxo Smith Kline. Ms Williams holds a B.S. in Pharmacy from the University of Rhode Island and an MBA from the University of Southern New Hampshire. She is also a Registered Pharmacist in the State of New Hampshire.
Who Should Attend?
EVPs, VPs, Directors, Heads, Managers, and Principal Scientists of:
Clinical Data Management
Clinical Project Management
Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 30,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.