An update on the development of combination product devices discussed at Pre-filled Syringes San Francisco 2021
As part of SMi’s Leading Injectable Series, this year’s event will address key drivers in the pre-filled syringe and combination product industry.
LONDON, LONDON BRIDGE, UNITED KINGDOM, June 2, 2021 /EINPresswire.com/ – Delegates can get a lot of valuable information from Pre-filled Syringes San Francisco with case studies highlighting developing approaches for device development and strategic platform approaches, design and application controls, and insight into the evolving connected device landscape.
Visit the event website to find out more and download the brochure on www.prefilled-sanfrancisco.com/einpr3
An update on regulatory guidance for combination products and injection devices
• A review of the current guidelines for pre-filled syringes and what was new from the last year.
• What has been the impact of COVID-19 on regulatory submissions and processes?
• An update on the expectations for regulatory submissions – common pitfalls and how to make sure you meet the requirements.
• A future perspective of changes to regulatory requirements and directions in the years to come.
Alan M. Stevens, Acting Director – Division of Drug Administration, General Hospital and Human Factors, CDRH, FDA
Strategic platform for combined products
• Optimization of development time, costs and risk reduction thanks to the platform
• How do you select your platform device and key lifecycle management considerations?
• The challenges in a unique approach
• Platforms for new pharmaceuticals and new device technologies
Scott Surrette, Director of Combination Product Development, Regeneron
Develop body delivery devices with the user in mind
• A perspective on the need for high volume injectors and high viscosity drug products.
• Delivery device technologies for sustained delivery
• A perspective on the evolution of delivery devices for new drug products
Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer
Regulatory Standards and Guidelines for Combination Product Instructions for Use (IFU)
• Types of user documentation
• Regulatory requirements for instructions for use
• Special considerations: support for color blindness, folding, font size
• Case study: Research on understanding the user manual for people with Parkinson’s disease
Shannon Clark, CEO, UserWise
Sign up online: www.prefilled-sanfrancisco.com/einpr3
Pre-registration offer register before June 30 and save $ 100
Sponsored by | Analytical Boston | Zéon | ZwickRoell
For all media inquiries, contact Jinna Sidhu on Tel. : +44 (0) 20 7827 6088 / E-mail: [email protected]
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Established since 1993, the SMi Group is a global event production company specializing in business-to-business conferences, workshops, masterclasses and online communities. We create and organize events in the defense, security, energy, utilities, finance and pharmacy sectors. We pride ourselves on having access to the world’s most forward-thinking thought leaders and visionaries, which allows us to bring our communities together to learn, engage, share and network. More information can be found at http://www.smi-online.co.uk
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