2018 ISPE Europe Aseptic Conference

Innovation in Aseptic Processing with Focus on New Regulation & Pharma 4.0

The ISPE 2018 Europe Aseptic Conference will focus on manufacturing technologies and support systems for the most relevant dosage forms for innovative drugs to come in the next years, which need to be produced in a sterile and aseptic environment. 

The globally relevant Regulation, the EC Guide Annex 1, drafted by the European Medicines Agency and widely commented by a number of industry stakeholders will be one major focus. The common understanding of the right approach in Quality Risk Management has become a hot topic in the conversation with the regulators. Data science workflows will lead to different ways to come to good management decisions in Quality Management. 

Innovation in technology of aseptic processing, such as isolators, barriers and robotics will eliminate operators impact on process and product and also protect operators from product as more and higher toxic compounds need to be handled. 

Aging facilities will create more and more questions about the right decision making to build new factories or update the existing ones. As always the answer is „it depends“.  There will be industry business cases presented for both ways to cope with the challenges of investment and delivering fast to the market needs. 

Technical challenges for decontamination, sterilisation, all kinds of transfers from materials between various hygienic zones will be addressed as well. Where „Ready-To-Use“ equipment or spare parts are advantageous, where not? What can automation support to keep good environmental conditions during production? 


Learning Objectives

  • Learn about the critical discussion topics between industry and regulators in sterile processing
  • See innovation in technology and automation
  • Look at industry best practise in applying data science and process science
  • See the business relevance of modern approaches to Quality Risk Management

Who should attend?

  • Engineering Managers & Directors
  • Engineers
  • Middle and Senior Management
  • Operations
  • PAT specialists
  • Pharmaceutical Executives
  • Plant Directors & Managers
  • Process Engineers
  • Production Managers
  • Project Leads
  • Project Managers
  • Project Managers
  • Regulators
  • Senior Scientist
  • Validation Specialists

Programme Committee

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Oliver Kurz
VP Quality Assurance
Vetter Pharma-Fertigung GmbH & Co. KG
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Volker Storn
Head Project Engineering and Execution
F Hoffmann-La Roche AG
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Martin Kern
Managing Director
MSD Animal Health Danube Biotech GmbH
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