Pre-Filled Syringes West Coast Reports New Updates in Regulation, Biologics, Device Design and ManufacturingSMi's 2nd annual show on Pre-Filled Syringes in San Diego, California to provide critical updates in five key areas surrounding the PFS industry.
By: SMi Group REGULATION AND STRATEGY: Allergan and Regeneron will navigate through the global regulatory ecosystem by discussing topical issues surrounding safety assessments, human factor considerations, product safety and complaint handling in both the commercial landscape and clinical trials. BIOLOGICS - CHALLENGES AND OPPORTUNITIES: Direction will be given to overcome challenges in large volume subcutaneous infusion devices. This session will also offer guidance on leveraging pre-existing data and provide further insight into combination product data bridging. Presenters will include Genentech, Nemera, Amgen and Terumo. DESIGN CONSIDERATIONS FOR PFS: Delegates will explore glass versus plastic, risk based control strategies for combination products and peptide formulations in PFS filled auto-injectors with Mitsubishi, Genentech and Xeris Pharmaceuticals. Attendees will also be invited to join the debate on PFS challenges and future opportunities in a panel led by Allergan, MedImmune, Ferring and Eli Lilly. THE HUMAN TOUCH: MedImmune, Worrell, Eli Lilly and Ferring will address questions such as: How can human factors be incorporated into device design? What steps should be taken for successful regulatory approval? What are the alternatives to PFS's in parenteral drug delivery? MANUFACTURING DEVELOPMENTS: With an aim to streamline manufacturing, Amgen, Zeon, Genentech, Nipro Pharmapackaging and Roche will discuss cutting edge technological breakthroughs in silicone free devices, COP, controlled depth radiation sterilization, laser assisted glass cutting technology, and needle clogging with high concentration protein solutions. A detailed brochure and full speaker line-up is available at www.prefilled- Pre-Filled Syringes West Coast June 5th and 6th Hyatt Regency, San Diego, CA www.prefilled- ---end--- Contact Information: For all media inquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email: tarri@smi-online.co.uk For all other inquiries contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email: amalick@smi- Pre-Filled Syringes West Coast event sponsors: Mitsubishi Gas Chemical Co, Nemera, Nipro Pharma Packaging, Overlook Industries, Steri-Tek, Terumo Europe, Worrell, Zeon Chemicals About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to- Photo: https://www.prlog.org/ End
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