Regulatory Opportunities and Challenges for Portable Manufacturing

Extended Learning
Learning Level: Beginner/Intermediate
Session Length: 1.5 hours

Portable manufacturing is a new paradigm that advances patient access through the speed and local accessibility of essential medicines. This presentation defines portable manufacturing and its potential use cases, explains the state of the industry, and explores the quality and regulatory challenges and opportunities that are afforded by applying location flexibility to manufacturing.

Learning Objectives

  1. Understand what is meant by portable manufacturing and its advantages
  2. Learn the state of the industry and the modalities that would benefit most from the technology
  3. Understand the quality and regulatory challenges that the approach creates and opportunities to advance the approval of technology from a regulatory perspective
Regulatory Opportunities & Challenges for Portable Manufacturing


Dennis Powers
Vice President of Business Development & Design Consulting
G-CON Manufacturing
Rosemary Orciari
Director Quality Operations
Pfizer, Inc.
Celeste Frankenfeld Lamm
Director, Global Regulatory Affairs-CMC
Merck & Co Inc

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