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Thursday, June 23 • 10:00am - 11:00am
#404: Combination Product Safety: A Journey of Organizational Transformation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-647-L04-P ; CME 1.00; RN 1.00

Panel discussion representing industry, FDA representation from OCP, and MHRA for global impact perspective.

Learning Objectives

Describe the impact of the combination product postmarket safety reporting rule by the FDA on industry; Discuss how its implementation has played out over the last two years and how FDA wants industry to modify its approach to the data being sent.

Chair

Khaudeja Bano, DrMed, MD, MS

Speaker

Moderator
Meredith Smith, PhD, MPA, FISPE

FDA Update
John Barlow Weiner, JD

Industry's Post-Implementation Journey Focused on PMSR Reporting of Malfunctions
Khaudeja Bano, DrMed, MD, MS

MHRA Update
Jenifer Hannon


Speakers
avatar for Khaudeja Bano

Khaudeja Bano

Vice President, Combination Product Quality, Amgen, United States
Dr. Bano is the Vice President of Combination product Quality at Amgen. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s... Read More →
JH

Jenifer Hannon

Head of Benefit Risk Evaluation Team II: Gastrointestinal, Nutrition, Endocrine, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Jenifer Hannon provides strategic leadership and management within the gastrointestinal system, nutrition, endocrine and fertility therapy areas within the Risk/Benefit function at MHRA. Her overarching objective is to ensure that safe and effective medicines and medical devices... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →
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 →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum |   09: Regulatory, Forum