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ISPE EU Conference: Innovation in Aseptic Processing – with Focus on New Regulation and Pharma 4.0
28. Nov 2018 - 29. Nov 2018
ISPE Europe Aseptic Conference
ISPE D/A/CH supports the EU Conference ‘Innovation in Aseptic Processing – with Focus on New Regulation and Pharma 4.0’ in Vienna.
The conference includes the ISPE D/A/CH affiliate 25th anniversary party, a social evening event in the Palais Ferstel / Vienna.
By the year 2025, every second new biopharmaceutical product will be considered highly potent and/or toxic with the oncology sector driving the growth. Highly potent/toxic products are a new generation of combined products like antibody drug conjugates (ADCs) or cell, immune, or gene therapies found in regenerative medicine. This new generation of products demands more stringent requirements for cleaning in multi-product facilities to prevent cross-contamination and provide occupational safety for the operators.
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?
– 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
– Middle and Senior Management
– PAT specialists
– Pharmaceutical Executives
– Plant Directors & Managers
– Process Engineers
– Production Managers
– Project Leads
– Project Managers
– Senior Scientist
– Validation Specialists
The conference adresses 4 Tracks:
Track 1: Quality and Regularity – Annex 1, Quality Risk Management and Data Science
Track 2: Isolator/Barrier/Robotics and Manufacturing High Potent Drugs
Track 3: Aging Facilities – the way to Facilities of the Future
Track 4: Decontanimation, Sterilisation, Transfers, E-Beam, Stoppers, RTU and Disposables
28th to 29th of November, 2018
Marriot Vienna Hotel
Could we spark your interest?
Contact: ISPE D/A/CH Secretary Rolf Sopp (rolf.sopp(at)ispe-dach.org)