Philadelphia Chapter In Person Event: Navigating Evolving Topics in Combination Products: Human Fact

Registration Fees & Deadlines

Speakers

Heather Guerin, Ph.D.
Global Program Regulatory Director, Novartis

Heather Guerin is Global Program Regulatory Director for Medical Devices at Novartis, where she is responsible for regulatory strategy for drug‑device combination products. She has extensive experience spanning medical devices and combination products including delivery systems for biologics, small molecules, and cell and gene therapies, as well as in diagnostics used in drug clinical trials. Heather has worked across therapeutic areas such as oncology, immunology, ophthalmology, maternal‑fetal medicine, and infectious disease. She holds a PhD in Mechanical Engineering from the University of Pennsylvania, a BS from Villanova University, and is a licensed Professional Engineer in Pennsylvania.

Becky Leibowitz, Ph.D.
Senior Director, CMC Regulatory Affairs, Combination Products – Johnson & Johnson Innovative Medicine

Becky Leibowitz is a Senior Director in Global CMC Regulatory Affairs at Johnson & Johnson Innovative Medicine, specializing in drug–device combination products.  She leads a team responsible for interpreting and informing new product and lifecycle management teams of evolving global health authority regulations and guidance for combination products and stand-alone devices used with drug products.  She and her team have contributed to clinical trial and marketing applications worldwide, Human Factors Validation study protocol submissions to FDA, and EU MDR Article 117 submissions to Notified Bodies, and are active in external industry organizations, collaborating with global health authorities and contributing to the advancement of the regulatory landscape for drug–device combination products. Becky holds both a B.S. and Ph.D. in Mechanical Engineering.

Regan Lawson, Ph.D.
Managing Scientist – Exponent

Regan Lawson is a Managing Scientist in Human Factors at Exponent. She specializes in evaluating how human capabilities and limitations, perceptual, cognitive, and developmental, in conjunction with environmental factors, affect decisions, actions, and behaviors when interacting with medical devices. She has extensive experience advising manufacturers on product safety compliance and usability in alignment with FDA guidelines. Dr. Lawson has worked with multiple medical device manufacturers, providing practical, data-driven advice on hazard identification for both patterns of expected use and misuse. She is skilled in diverse methodologies, including heuristic evaluations of labeling, use-related risk analyses, identification of critical tasks, and usability assessments to evaluate how users interact with medical devices, including combination devices. She also holds specialized AAMI training for conducting human factors validation testing and preparing HFE validation study reports for regulatory submissions.

Marta Villarraga, Ph.D., RAC (Moderator)
Principal – Exponent

Marta Villarraga is a Principal in Biomedical Engineering & Sciences at Exponent. She has expertise in evaluation of medical device performance during the premarketing and postmarketing stages. She has experience with orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, and diagnostic medical devices.

Dr. Villarraga has provided technical support for due diligence, regulatory submissions, regulatory compliance, risk management, postmarketing surveillance, product development, government investigations, product liability, and intellectual property matters. Dr. Villarraga uses her knowledge of the U.S. FDA regulations to develop regulatory strategies for novel products, contribute or prepare regulatory submissions, and to support identifying and justifying technical evaluations for pre-market assessments and postmarket compliance matters. She holds a Ph.D. in Biomedical Engineering from Tulane University and RAC in US and Devices.

Location

Exponent (One uCity Square)
25 N 38th St
Ste. 700
Philadelphia, PA 19104

Sponsor

Exponent

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions