Pre-filled Syringes and Injectable Devices
SMi Reports: Renowned industry experts to present on the Pre-Filled Syringes and Injectable Drugs Pre-Conference Workshop Day taking place in January 2020.
SMi Group presents Europe’s Pre-Filled Syringes and Injectable Drug Devices conference on the 15th – 16th January 2020. The event will assess innovations in device engineering and components, enhancement of human factors, and optimizing packaging and containment. There will also be a Pre-Conference Workshop Day commencing on 14th January 2020.
Highlights of the event:
- Explore design controls, life cycle management and risk management strategies for PFS
- Understand the current regulatory environment of PFS from leading advisors
- Delve into formulation and container interaction considerations and best practices
- Learn from industry experts in an interactive pre-conference workshop day
The Workshop day will consist of 3 workshops led by industry experts Amanda Matthews, Senior Director, Pfizer; Horst Koller, CEO, HK Packaging Consulting and Carsten Worsøe, Principal Scientist, Novo Nordisk Raphael Nudelman, Director of Chemical and Computational Toxicology, Teva Pharmaceuticals.
There will be an early bird saving of £400 for registrations made by 30st September available here www.pre-filled-syringes.com/pharmapr2
Workshop A: ‘A Roadmap to Regulation Quality Management Systems and Technical Standards’ led by Amanda Matthews, Senior Director, Pfizer
Aiming to provide regulatory considerations to navigate and prepare for implementing the upcoming changes in the management systems and technical standards for the medical device and combination product development. With the implementation of new regulatory requirements and standards such as the EU MDR, Article 117, post marketing safety reports, the ISO change management standard and the revision to ISO 14971, it is increasingly important for companies to prepare for this paradigm shift
Workshop B: ‘Testing Requirements of Pre-Filled Syringes led by Horst Koller, CEO, HK Packaging Consulting GmbH’ led by Horst Koller, CEO, HK Packaging Consulting
The Workshop will describe the regulatory testing requirements of pre-filled syringes. It will give an overview of materials used for PFS as well as the need for testing throughout the different stages of a PFS.
Workshop C: ‘Extractables and Leachables: Considerations for PFS Platforms’ led by and Carsten Worsøe, Principal Scientist and Novo Nordisk Raphael Nudelman, Director of Chemical and Computational Toxicology, Teva Pharmaceuticals.
When developing a successful combination product, the examination of risk of extractable and leachable contamination and container interaction is key to ensuring correct and safe drug delivery. The topic of extractables and leachables is a key consideration in many fields of pharmaceuticals. This workshop will focus on the challenges and regulations within combination products and pre-filled syringes, discussing how we can improve as an industry to provide a comprehensive roadmap for successful and effective testing.
View the full agenda and speaker line-up online: www.pre-filled-syringes.com/pharmapr2
Pre-Filled Syringes and Injectable Drug Devices
15th – 16th January 2020
Proudly sponsored by:
- Harro Hofliger
- Mitsubishi Gas Chemical
- Nelson Labs
- phc Corporation
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About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk