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Conference Overview

This European Annual Conference draws pharmaceutical and biopharmaceutical professionals at all levels of the industry - from students and emerging leaders to the most senior executives in drug manufacturing, supply chain, devices, equipment and services, and global regulatory agencies. We welcome you to participate at the 2024 ISPE Europe Annual Conference to learn and share progress, success stories, best practices and lessons learned.

Key Conference Takeaways

Keynotes

  • Progress and commercialization of new therapy concepts; example of autologous cell therapies
  • EMA's and FDA's view on the industry's preparedness, performance, and challenges for integrating innovation - QRM is in the center! 
  • Business roadmap
    • How top manufacturing companies organize the digital transformation: chances, opportunities, benefits, risks and obstacles
    • When reality meets theory in Pharma 4.0 environment.
  • Metaverse, a parallel universe of data: how and when can it help the pharmaceutical industry?

Regulatory Panels

  • Regulatory Panel 1 with FDA, EMA, WHO and INFARMED
    • This panel will focus on harmonization to break down barriers to robust supply chains. What can industry and regulators deliver in a collaborative approach?
  • Regulatory Panel 2 with EMA and Danish Medicines Agency on regulatory preparedness for Digital Transformation.
    • A dialogue between regulators and senior industry leaders.
    • Where is the pharmaceutical industry today on the digital transformational journey from an industry perspective?
    • What about the master data management framework and governance structure? 
    • QRM-based approach in the light of updated ICH Q9:  e.g. formality, subjectivity, risk-based decision making, product availability?

Case Studies

  • Digital Transformation: Use Cases, Key Benefits, and Lessons Learned
  • Learnings from GXP Inspections to Prepare for the Future
  • Regulatory Restrictions and Drug Availability
  • Good Engineering Practice and Efficient Investment Management
  • GAMP® 5, FDA CSA, cloud computing SAAS, eBatch records with Pharma 4.0

For more information, visit the 2024 ISPE Europe Annual Conference webpage.

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