Learn how Alcon, Baxter and Roche Diagnostics are transforming their regulatory operations models to remain agile and effective through the ever-changing global regulatory landscape.
Watch this on-demand webinar to hear Larry Litle, Sr. Director Global Strategy & Delivery at Baxter Healthcare, Roxane Bonner, QA/RA Program Director at Roche Diagnostics, and Lori Holder, Senior Director, Regulatory Affairs Operations at Alcon, discuss the current environment with COVID-19 and the impact on regulatory operations.
Gain insights and real-world evidence from MedTech industry leaders, including:
- Challenges and opportunities of our current environment
- Ensuring commercial continuity with global regulatory collaboration and transparency
- Addressing the "New Normal" regulatory model with a technology-based program
Panelists:
Larry Litle
Sr. Director Global Strategy & Delivery
Baxter Healthcare
Larry leads Baxter Healthcare’s Global Regulatory Affairs (GRA) Global Strategy and Delivery (GSD) organization, designed to create an aligned and unified approach to regulatory support across the GRA organization. His primary focus is on simplifying regulatory processes and providing strategic support to business partners to further enable efficiency and effectiveness on a global scale, while delivering with excellence through speed, courage, collaboration and simplicity across the Baxter portfolio. Prior to Baxter, Larry served in senior leader roles within Johnson and Johnson and Sanofi-Aventis spanning local, regional, and global functional areas, within and linked to Regulatory Affairs.
Lori Holder
Senior Director, Regulatory Affairs Operations
Alcon
Lori Holder is the Director of Global Regulatory Operations at Alcon Laboratories, Inc., a leading manufacturer of ophthalmic medical devices located in Fort Worth Texas. She has over 25 years of experience in the medical device industry through positions at Guidant Corporation, Sulzer Orthopedics, Sulzer Intermedics, and Cyberonics, Inc. She has held positions of increasing responsibility in clinical research, quality assurance, and regulatory affairs, and currently is the head of Alcon’s Regulatory Operations group. Lori has earned her Regulatory Affairs Certification (RAC) and has a B.S. in Biomedical Engineering from Texas A&M University.
Roxane Bonner
QA/RA Program Director
Roche Diagnostics
Roxane is the QA/RA Program Director for Roche Diagnostics managing varying responsibilities across regulatory affairs, quality systems, project management, product development and change management for in vitro diagnostics and medical devices. Prior to Roche, she spent fifteen years as a Molecular Biologist at the University of Arizona, Motorola Life Sciences and GE Healthcare.
Terri Howard
Director Strategy
Veeva MedTech
Terri Howard has more than 20 years of experience in life sciences, with the last decade focused on regulated content management technology for the medical device industry. She has worked with industry leadership teams to form and influence change in regulatory business practices, most recently at CareFusion, now BD. Howard joined Veeva Systems in 2015 as director of strategy to help medical device companies leverage cloud technology to bring products to market faster and more efficiently.