ISPE Expert Xchange: Distributed & Decentralised Manufacturing – Moving the Conversation Forward

Learning Level: Intermediate
Session Length: 1.5 hours

Innovation in the pharmaceutical industry doesn’t stop with the medicines themselves. Manufacturers must also examine processes, facilities, and the supply chains for opportunities to ensure the most efficient production and delivery of drugs to patients. One such innovation that sparks the imagination of regulators and industry alike is Distributed/Decentralized Manufacture (DM). In DM the traditional model of a single, large capacity manufacturing site with a large complex distribution network, is transformed to encompass multiple, highly similar manufacturing sites, across different locations or regions. In this Expert Xchange we bring together all who have a stake, to share the latest regulatory positions and pathways to enable DM, and discuss the remaining challenges, including proposals for how one might take a risk-based approach to DM.

First-hand Strategic Insights & Actionable Takeaways

  1. Describe the current regulatory environment for distributed/decentralized manufacturing
  2. List ongoing challenges to implementation
  3. Discuss, or propose, solutions to further enable DM
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!

ISPE Expert Xchange Session Speakers & Panelists

Vered Caplan
Evdokia Korakianiti
Head of Quality and Safety of Medicines
Celeste Frankenfeld Lamm
Director, Global Regulatory Affairs-CMC
Merck & Co Inc
Riley Myers
Chief, Advanced Pharmaceutical Manufacturing Laboratory


ISPE Expert Xchange Rates


Member $99
Nonmember   $149 
Academia/Emerging Economy/Government $49
Student   $15 

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ISPE Membership Benefits

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Benefits include:

  • Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
  • Member-only discounts on Guidance Documents, Conferences, and Training
  • Pharmaceutical Engineering® magazine
  • Communities of Practice access to pharma professionals in specific topics from around the world
  • And more
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