Events

Prev Month	View Month	Search	Go to Month	Next Month

2024-05 Spring Symposium_Combination Products_S. Neadle

DoubleTree by Hilton Hotel Raleigh-Durham Airport at Research Triangle Park
4810 Page Creek Lane
Durham, NC 27703

View additional information

Monday, May 20, 2024, 5:30 PM - 9:00 PM EDT

Category: Events

Regulatory Strategy for Drug-led Combination Products

Speaker: Susan Neadle, MS, BS, FRAPS, FAAO; Principal Consultant at Combination Products Consulting Services LLC

DESCRIPTION:

The regulatory strategy for the combination product is critical for guiding activities from development through lifecycle management of combination products. This presentation focuses primarily on the development and refinement of the regulatory strategy and submission planning and execution for drug Primary Mode of Action (PMOA) combination products, which combine a drug or biological product with a medical device. Many of the concepts discussed can also be applied for device PMOA combination products and for drug-biologic combination products. This presentation outlines the key considerations for developing the strategy, including (i) product designation and jurisdiction, (ii) implications of the commercial presentation and identification of the regulatory design inputs, and (iii) combination product regulatory strategy execution.

SPEAKER BIOGRAPHY:

Susan Neadle, MS, BS, FRAPS, FAAO is a recognized international Combination Products expert with over 30 years industry experience. Susan is well networked and highly active in numerous industry groups with links to
multiple teaching institutions. Her leadership, innovation, and best practices have been recognized with several awards, including Fellowship in the Regulatory Affairs Professional Society (RAPS), the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; a 2021 TOPRA Awards Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development. She has recently published FDA-peer reviewed and AAMI-endorsed “The Combination Products Handbook: A Practical Guide” through CRC Press (www.routledge.com/9781032291628).

Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, applying her extensive leadership,
technical skills and experience to provide international quality, regulatory affairs, executive advisory and design excellence services, to the pharmaceutical, biotech, and medical device industries. She
continues to fulfill her passion in this space as Chair of the AAMI Combination Products Steering Committee, and Lead Author in Combination Products Working Groups, e.g., AAMI TIR 48:2023. She is
also transitioning from her multi-year role serving as Chair of the ISPE Combination Products CoP. Susan teaches at multiple venues, including UMBC, AAMI and through her consulting firm. She is also active in
multiple industry working groups and steering committees including AFDO/RAPS, CPC, TOPRA, and MediPhorum, and enjoys speaking at a variety of industry forums. Susan can be reached at [email protected].

EVENT DETAILS AND REGISTRATION:

The event features a networking reception from 5:30-6:30 pm, followed by buffet dinner and seminar presentation from 6:30 - 8:30 pm.
This event will be in-person only.

REGISTER BELOW by May 10 for the best rate! Through May 10, registration for the public is $75; NCRAF standard members $50; NCRAF student/postdoc/unemployed job-seeker members $25.

After May 10, all registration fees increase by $10 ($85 public / $60 member / $35 student etc.)