Over recent years, pre-filled syringes have become the primary container of choice for the majority of parenteral drug delivery systems. With pre-fillable syringe systems improving safety and increasing convenience, it is clear to see why there has been such a rapid growth of such syringes to treat a wide range of acute and chronic conditions.
This unique masterclass will consider factors effecting pre-filled syringe development and will provide the perfect opportunity for attendees to discuss design techniques and migration, extractables and leachables studies, with an expert in the parenteral field. This event will also focus on best practice strategies when working with regulatory authorities and producing an effective regulatory strategy.
- Analyse current regulatory guidance and strategy management
- Share insight with experienced specialists in the fields of leachables and extractables
- Learn about relevant cases studies in analysis and selection
- Develop solutions to challenges in the field
- Debate how best to develop a regulatory strategy with the authorities
- Network with key industry executives
About the Workshop Leader: Mr. Horst Koller started his professional career in 1994 to work for a large pharmaceutical company in Germany managing the Process Engineering Group. In 2000 he joined Schott in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the Schott TopPac® polymer syringe within Schott AG. He held different positions including Quality Manager, Head of R&D, Manager Scientific Advisory and Manager Global Regulatory Affaris and Quality R&D. In his current position he is responsible for the global Technical and Quality Support syringes for Schott Pharmaceutical Packaging. He is an active member as expert of ISO/TC 76/ working groups and a frequent speaker at extractables & leachables as well as Prefillable Syringe conferences. He holds a degree as Dipl. Ing (FH) in Biotechnology.
SCHOTT Pharmaceutical Systems is one of the world’s leading suppliers of glass tubing and primary packaging for the pharmaceutical industry. We provide our customers quality solutions while meeting their highest demands with our material expertise, specialized analytical lab services, and a broad product portfolio; including, syringes, cartridges, vials, ampoules, and special articles made of glass and COC polymer. With four glass tubing production sites and seventeen sites for pharmaceutical packaging spread over four continents, we offer safe supply and local service. Our state-of-the-art production facilities and our products comply with the highest international quality standards for pharmaceutical needs.