RAPS Regulatory Intelligence Conference

Chris Whalley

Sr. Director & Head of Global Regulatory Intelligence & Analysis, Pfizer, RAPS Convergence Planning Committee Chair

No bio provided

: chriswhalley

Linda Bowen

Adjunct Professor, Temple University Pharmacy School

Linda is an accomplished regulatory professional with experience leading strategy, intelligence and policy teams, with a wide network built through active engagement and participation in discussions and negotiations with health authorities, trade associations, consortiums and professional organizations. She has spent the last 30+ years in regulatory strategy, policy, and intelligence roles at Pfizer (Seagen), Sanofi, Bayer, and GSK (Block Drug). She has been an Adjunct Professor in the Temple University RAQA graduate program since 1998.

Linda attained regulatory affairs certification for the US, Canada, and Europe, and was an inductee to the 2011 Class of RAPS Fellows. She was honored with the RAPS 2020 Founder’s Award as well as the Drug Information Association's 2012 Excellence in Volunteer Leadership, the 2019 Americas Inspire Awards, and the 2022 Global Inspire Award - Community Engagement.

She is a past two-term member of the RAPS Board of Directors, current chair of the RAPS Industry Board, and has been part of the leadership team of the NJ/NY RAPS Chapter since its inception (2003). Linda is past chair of the DIA Regulatory Affairs Community and founder of the DIA Regulatory Intelligence Working Group (2006). She sat on the planning committee for 2013-2017 DIA Annual Conference, the 2011-2017 RAPS Annual Convergence and was program chair for the 2018 & 2019 RAPS Annual Convergence. She is on the planning committee for the RAPS 2024-2027 Regulatory Intelligence Conference, an advisor for the RAPS Regulatory Intelligence Conference Europe, and hosts the RAPS Regulatory Intelligence Collaborative Community.

She is most proud of her role as an educator and mentor to those entering the regulatory affairs profession.

: linda-bowen-msc-rac-fraps-350b484

Geethapriya (Priya) Setty

Regulatory Intelligence & Strategy, Hologic

Geethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with a deep belief in purpose-driven innovation. With over a nine years of experience in global regulatory affairs and more than decade in healthcare, she brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology. Starting her career as an occupational therapist, Priya’s focus has always been on impact- adding life to years, not just years to life. Today, she leads regulatory intelligence and digital transformation initiatives at a global medical device company, where she designs scalable systems to track emerging regulations, accelerate compliance, and enable access to life-changing technologies. Her work includes spearheading the development of an AI-powered Regulatory Intelligence platform that cut manual effort by 94 percent and brought real-time insights to global regulatory teams. She has also led the enterprise-wide implementation of a global Regulatory Information Management platform, driving requirements gathering, process alignment, and change management to standardize regulatory data and submissions across her organization. She has supported cross-functional teams in advancing regulatory strategies for high-risk and breakthrough devices, contributed to early responses to policies like the EU AI Act and FDA's evolving digital health guidance, and partnered across R&D, clinical, and quality functions to help build compliance into innovation from day one. Priya holds dual MBAs and is certified in RAC (Devices), PMP, ISO 13485 auditing, and medical device compliance. She thrives at the intersection of technology, policy, and strategy, and is known for her ability to bring clarity to complexity. Her mantra "make a choice, and make it happen" guides how she leads, builds, and mentors. Whether supporting teams through regulatory change or architecting AI-enabled solutions, she remains grounded in the mission that first drew her to healthcare: to serve, to simplify, and to make healthcare innovation more human.

: geethapriyasetty