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Wednesday, June 22 • 2:00pm - 3:00pm
#353: Planning for the Worst: Approaches for Drug Shortage Avoidance

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-630-L04-P ; CME 1.00; RN 1.00

Drug shortages have been a long-standing challenge globally and while progress has been made through various regulatory measures and industry initiatives, the COVID-19 pandemic and the pressure it has placed on the drug supply, continues to demonstrate there is more work to be done. This session will provide a contemporary view of the drug shortage avoidance landscape and insight into existing and evolving regulatory requirements. Advanced industry and regulator experts will demonstrate risk evaluation practices and approaches for drug shortage avoidance at different altitudes through discussions regarding how: • Governments, manufacturers, distributors, and providers may reduce the frequency and duration of drug shortages through transparency, • Manufacturers may evaluate product availability risks in alignment with ICH Q9 and establish effective mitigation strategies, and • How risk-based sampling may mitigate interruption of critical drug product supply during disruptive events related to an FDA Import Alert 66-40. Join the DIA Regulatory Affairs Community for a follow up round table discussion (session #356 RT) on Wednesday, June 22, 3:00pm - 4:00pm.

Learning Objectives

Describe drug shortage avoidance topics and related pressures generated from COVID-19; Describe the importance of risk evaluation and mitigation approaches;industry-wide opportunities, manufacturer best practices, and challenges experienced during specific disruptive events; Identify the current and potential future state for risk analysis, manufacturing reliability, supply chain resiliency and regulatory requirements for uninterrupted supply of critical drug products for patients.


Diane Hustead, MS


Risk Assessments for Drug Availability
Christine Moore, PhD

Risk-Based Mitigation of Quality Issues to Alleviate Drug Shortages
Diane Bruce, PharmD, RAC

Risk and Resilience in the Upstream Medicine Supply Chain
Michael Levy, MBA, MSc

Drug Shortage Outlook in 2022
Erin Fox, PharmD

avatar for Diane Bruce

Diane Bruce

Senior Advisor to OMQ - Drug Shortages, OC, CDER, FDA, United States
Diane Bruce is the Senior Advisor to OMQ - Drug Shortages in CDER's Office of Compliance. She has been with CDER's Office of Compliance for nine years and is responsible for overseeing and developing drug shortage management within the Office of Manufacturing Quality. Prior to working... Read More →
avatar for Erin Fox

Erin Fox

Senior Pharmacy Director, University of Utah Health Care, United States
Erin has lead University of Utah’s national drug shortage work since 2001 providing content for the ASHP Drug Shortage Resource Center. She is nationally recognized for her expertise in drug shortages and she serves as a media resource and advocate to improve the ongoing drug shortage... Read More →
avatar for Diane Hustead

Diane Hustead

Executive Director, Regulatory Affairs, Merck & Co., Inc., United States
Diane Hustead is an advanced regulatory affairs expert and drug shortage industry leader with enthusiasm and dedication to pharmaceutical manufacturing excellence. With a diverse career path and continuously increasing responsibility over her 25 years at Merck, she has developed expertise... Read More →

Michael Levy

Senior Vice President, Digital and Innovation, US Pharmacopeia, United States
Michael Levy is Senior Vice President, Digital and Innovation. In this role, Mr. Levy oversees several forward-looking pillars of activity, including Research and Innovation, Digital & Informatics, and the Pharmaceutical Supply Chain Center. His diverse background includes shaping... Read More →
avatar for Christine Moore

Christine Moore

Executive Director, External Advocacy and Standards, Organon & Co., United States
Christine Moore is a founding member of Organon where she leads Global External Advocacy and Standards, with oversight for new GMP-related policy, analytical standards and compendial affairs. Christine started her career as a process development engineer, after which she moved to... Read More →

Wednesday June 22, 2022 2:00pm - 3:00pm CDT
Room 183 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Session