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Monday, June 28 • 4:00pm - 5:00pm
#151 SL: Next Generation of Combination Products: Insights from the FDA Office of Combination Products and Industry Expert Application

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-555-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will present FDA regulatory insights and discuss examples of current trends in the space of combination products. A panel of FDA representatives will provide updates on FDA policy and industry experts will share practices on application.

Learning Objectives

Discuss and analyze the latest FDA regulatory expectations and challenges; Recognize current topics the FDA is observing and what industry should continue to do and what is causing challenging circumstances.

Chair

James Wabby, MHS

Speaker

FDA Update
John Barlow Weiner, JD

Panelist
Susan Neadle, MS

Panelist
Kate Gillespie, BSN, MBA



Speakers
avatar for John Weiner

John Weiner

Associate Director for Policy, Office of Combination Products, OCPP, OC, FDA, United States
John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, Abbvie, United States
James Wabby is the Executive Director of Regulatory Affairs (Emerging Technologies and Combination Products) at AbbVie in Irvine, California. He has over 20 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
KG

Kate Gillespie

Senior Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson, United States
SN

Susan Neadle

Executive Director & Head, Combination Products, Devices, Diagnostics & Digital, Amgen, United States
Susan Neadle, MS, BS, FAAO, a DEx and PE Black Belt, is now Executive Director, Combination Products, Devices , Diagnostics & Digital Health RA, at Amgen. This follows a very successful career of 25+ years at Johnson & Johnson, where she held integral leadership roles in R&D and QA/QE... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum