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Tuesday, June 18 • 3:15pm - 4:15pm
#275: Security the Chain: US Legislative Reforms, Regulatory Actions, and Recommendations to Mitigate Drug Shortages

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

There have been many legislative and regulatory efforts in the US to address drug shortages and address assurance of supply. This session will provide an overview of these legislative and regulatory actions and provide recommendations to support drug shortage mitigation and supply chain transparency. This session will also demonstrate why addressing the issue of drug shortages is so critical, by addressing the impact of drug shortages from the patient perspective.

Learning Objectives

Define various US legislative and regulatory actions to address drug shortages and understand their impact on assurance of supply and supply chain transparency; Understand the direct impact of drug shortages to the patient; Discuss themes and industry recommendations to address drug shortage prevention.

Chair

Demetra Macheras, MBA

Speaker

Patient Perspective
Laura Bray, MBA

Evidence-Based Policy Reforms to Reduce Drug Shortages Today and Into the Future
Tony Lakavage, JD

ISPE Drug Shortages Initiative: Where We Have Been and Where We Are Going
Demetra Macheras, MBA


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
LB

Laura Bray

Founder and Chief Change Maker, Angels for Change, United States
Laura Bray is Chief Change Maker and founder of Angels for Change. Founded 2019, Angels for Change is a global, volunteer-supported, non-profit organization on a mission to end drug shortages through advocacy, awareness, and a resilient supply chain. Laura has advocated for patients... Read More →
avatar for Tony Lakavage

Tony Lakavage

Senior Vice President, Global External Affairs, USP, United States
Anthony Lakavage is Senior Vice President, Global External Affairs, and Secretary, USP Convention and Board of Trustees. In his role, Mr. Lakavage oversees Global Communications, U.S. and International Public Policy and Regulatory Affairs, Global Stakeholder Engagement, Board and... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
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