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 supporting systems for the most relevant dosage forms for innovative drugs to come in the next years, which need to be produced in 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

Rolf Sopp photo
Rolf W. Sopp
ISPE D/A/CH Affiliate e.V. / Secretary
DACH Afflilate
Gunter Baumgartner photo
Gunter Baumgartner
"Head of Global Engineering VP Global Manufacturing and Supply"
Takeda Pharmaceuticals International AG
Josef Kriegl photo
Josef Kriegl
Managing Director
Chemgineering International GmbH
Jean Francois Duliere photo
Jean Francois Duliere
Pharmacy Senior Consultant
Consultant
Michelangelo Canzoneri photo
Michelangelo Canzoneri
Digital Operations Leader, Corporate Industrial Affairs
Sanofi
Paul Fiorio photo
Paul Fiorio
Global Pharma Compliance and Inspection Head
Novartis
Gert Moelgaard photo
Gert Moelgaard
Senior Consultant
Moelgaard Consulting
Charlotte Enghave Fruergaard photo
Charlotte Enghave Fruergaard
Partner, Front End
NNE
Richard Denk photo
Richard Denk
Head Sales Containment
SKAN AG
Viktor Mettler photo
Viktor Mettler
Global Quality Lead REFS
Novartis Pharma AG
Oliver Kurz photo
Oliver Kurz
VP Quality Assurance
Vetter Pharma
Joerg Zimmermann photo
Joerg Zimmermann
Vice President Vetter Development Service
Vetter Pharma Fertigung GmbH & Co KG
Volker Storn photo
Volker Storn
Head Project Engineering and Execution
F Hoffmann-La Roche AG
Martin Kern photo
Martin Kern
Site Director
Merck