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Tuesday, June 18 • 3:15pm - 4:15pm
#275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation

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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

With efforts in the US and Europe to increase supply chain transparency and prevent drug shortages, this forum focuses on recent and pending regulatory updates. We examine actions taken to mitigate product shortages following an unpredicted event impacting product shortages and lack of supply predictability.

Learning Objectives

Define the impact of US and European legislation updates on supply chain integrity and efforts to promote domestic manufacturing; Recognize how regulatory actions to prevent and mitigate product shortages are aimed at improving patient access and transparency across the supply chain; Discuss a case study on how the partnership between industry and regulatory can mitigate unpredictability.

Chair

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 →

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