The World of Pre-filled Syringes and Injectable Devices Americas 2013 Summit
World of Pre-filled Syringes and Injectable Devices Americas 2013 Summit
Paradigm Global Events is proud to present World of Pre-Filled Syringes & Injectable Devices Americas 2013 Summit.
Pre-filled syringes are becoming more popular as a quicker, more effective way to administer drugs. Yet they come with challenges and technical hurdles. This 2-day conference examines several topics in the arena of pre-filled syringes, including the human aspect, (design and patient safety); quality by design issues; and challenges with extractables/leachables. The event is designed for senior executives involved with the manufacturing
New technologies for drug delivery: NANOTECHNOLOGY
What technologies are becoming more available for driving the use of nanotechnology? What are the restrictions on the effective use of nanotechnology in drug delivery?
New technologies for drug delivery: WIRELESS/ELECTRONIC
What are the ramifications for using wireless technology in drug delivery?
What extra clinical tests have to be done to prove efficacy?
The current regulatory landscape for drug delivery
What do the FDA need to know to make decisions on approval Working in partnership with the FDA to improve regulation Future regulatory landscape – what will companies need to know?
Smart, localised drug delivery: improving efficacy
Learn how localised drug delivery can mean better delivery How it can work for oncology: ultrasound, etc
Biologics and drug delivery Latest advances in delivery of biologics
Obstacles in biologics delivery: oral delivery; etc
Patient-friendly delivery: is it the future?
Putting the patient first: user-centric drug delivery
Increasing the use-ability of drug delivery and hence its possibilities for product development
Designing a better, simpler method of drug delivery to make delivery more effective Patient adherence and drug delivery: better adherence equals better drug delivery
A drug delivery partnership model
Successful collaborations to improve portfolio of delivery methods
Why you should attend?
• Discover new developments in the technology used to make pre-filled syringes and Injectable and medical devices.
• Learn about the market for pre-filled syringes, injectable and medical devices
• Explore the opportunities for outsourcing of pre-filled syringes, injectable and medical devices, challenges faced and cost effectiveness.
• Investigate the barriers for siliconisation, and the options available to overcome these
• Optimize the stability of products in pre-filled syringes.
• Examine new developments in the formulation of products to be packaged in pre-filled syringes: proteins, vaccines, anticoagulants.
• Learn about the use of lyophilised products in pre-filled syringes and delivery techniques.
• Gain an insight into the development of dual chambers, and contributing factors.
• Discuss the regulatory issues about the standardisation of pre-filled syringes, injectable and medical devices.
• Establish what inspection technologies are available to ensure validity and quality of pre-filled syringes and injectable devices.
• Tackle challenges relating to syringe components – stoppers, plungers, barrels.
• Learn about developments in filling techniques – volume, viscosity, foaming, reduction of the risk of trapped air in the syringe.
• Advantages of pre-filled syringes, cost benefits, ease of access, reduced wastage,
• Investigate the composition of syringes – glass vs. plastic.
• Source information about sterilisation techniques for syringes: e-beam technology, sterile manufacturing, x- ray capabilities.
• Survey the future of pre-filled syringes and Injectable devices and how they factor in the drug delivery systems.
Who should attend?
VPs, Directors, Heads, Managers of: Pharmaceutical & Biotech companies
• Packaging & Labeling
• Manufacturing Product design
• Technical support
• Drug product process development
• Drug device process development
• Pharmaceutical sciences Safe medication practice
• Drug device safety
• Contract sales/marketing organisations
• Business development
• Product management and sales
• Pharmaceutical, healthcare and life sciences consultants
• Partners and senior counsel
Pre – Conference Workshop
• Outsourcing manufacturing of pre-filled Syringes
• Selection of partner
• KPI’s and measurement of tangibles
• Risk assessment and management
• Other challenges with outsourcing manufacturing [/tab]
Your Key Speakers
The World of Pre-filled Syringes and Injectable Devices Americas 2013 Summit
Day 1 – 11th July 2013
08:00-08:50 – Registration & Coffee
08:50-09:00 – Chairman’s welcome
09:00-09:40 – The current market for prefilled syringes and future trends
• Realising the present demand for new, innovative drug delivery methods
• Knowing how the patent cliff is helping to change that demand
• Understanding the move towards better technology to improve drug delivery and its ramifications
09:40-10:20 – Regulatory Update on the Industry
• Definition of a pre-filled syringe: product or device?
• The latest FDA thinking
• The issue of autoinjectors
• Manufacturing Process, Container Closure aspects
• Agency feedback: Licensing
• The regulatory Horizon
10:20-11:00 – Networking Morning Refreshment (Exhibition Area)
11:00 – 11:40- Patient safety: a perspective
• Current use and application of 1 ml PFS
• Challenges and limitations of 1 ml PFS
• Solutions to these challenges
• Future Trends (driven by these challenges).
Andrew Donnelly, Associate Director, Formulation Sciences, MedImmune
11:40-12:20 – Formulation and Pre-filled Syringe Development for Biosimilars
• What are the common obstacles in development?
• Specific in biosimilar syringe development
• Case studies
12:20-13:00-PANEL DISCUSSION: Technical challenges for designing and manufacturing pre-filled syringes
13:00-14:00 – Networking Lunch
14:00-14:40 – New Sterilization Solution for Prefilled Syringes
• Continued education on current and new sterilization processes
• Understanding of the bene???ts and limitations of nitrogen dioxide sterilization; and
• Allow attendees to become a resource to their organization on the challenges and solutions of sterilizing pre???lled syringes.
Dr. David Opie, PhD Sr. Vice President, Research and Development Noxilizer, Inc.
14:40-15:20 – Pre-filled syringes processing with RABS, Isolators, E-Beam and alternative and total room decontamination with H2O2 vapors
• Isolator technology with latest E-Beam design features
• Alternative tub entry system for slow speed production
• Expansion of the areas of nested syringe filling technology to aseptic/toxic
• Comparison of use of RABS to Isolators
• Total cleanroom decontamination using H202 vapor
Les Edwards,MSE, Director, Eastern Region, SKAN USA
15:20-16:00 – Networking Afternoon Refreshment (Exhibition Area)
16:00-16:40- Prefilled syringes and packaging
• What factors to take into account for packaging and prefilled syringes
• Primary and secondary packaging: what solutions are most effective
• Future packaging: what’s on the horizon?
16:40-17:20 – Proven Glass Coding Technology allows for full Traceability in Production and the Supply Chain
• Total visibility of the manufacturing process through batch record/pedigree on item level
• Preventing of mix-ups between production lots even of unlabeled containers
• Methods to support filling lines clearing after product change
• Identifying a single item in the after sales supply chain to authenticate its original provenance to fight against product piracy
17:20 – 17:30 – Chairman’s comments End of Day 1
17:50- Networking Drinks Reception at the Exhibitors area. Take your discussion further and build new relationships in a relax and informal settings.
Day 2 – 12th July 2013
08:00 – 08:50 – Registration & Coffee
08:50-09:00 – Chairman’s welcome & opening remark
09:00-09:40 – Quality by Design and Risk Assessment Approaches for Commercial – Scale Prefilled Syringe Manufacture
• Describe an approach to QbD and risk assessment for commercial-scale manufacture of PFS
• Specifically focus on component preparation and prefilled syringe unit operations for PFS manufacture
• Review factors to consider in risk assessment for these unit operations
• Provide focus to prioritize experimental efforts
• Provide examples of experimental design and implementation to gain process understanding of parameters relevant to PFS
Andrea Paulson, Associate Research Fellow, Pfizer
09:40-10:20 – Product-container interaction: the impact on the drug
• Why product-container interaction is to be avoided
• Lessons in avoiding immunogenicity
• Interactions with primary packaging
• Will new materials/technologies help with the issues?
• Difference between interactions in glass and plastic syringes
10:20-11:00 – PANEL DISCUSSION: Quality by design in manufacturing for pre-filled syringes: challenges and opportunities
11:00-11:40 – Networking Morning Refreshment (Exhibitors Area)
11:40-12:20 – Biologic Pre-filled Syringes and Injectable Devices
• Review of Different Types of Drug Delivery Systems
• Particular Applicability of AutoInjector for Delivery of Biologics
• FDA Classification & Regulating of Drug Delivery Technologies
• Applicable FDA Guidances
• Technical & Human Factors Testing
Stuart Portnoy, MD, Senior Consultant, Medical Devices, Biologics Consulting Group
12:10-13:00 – Pre-filled syringes and biotech drugs
• The current market for biotech drugs
• Future possibilities for pre-filled syringes and biotechs
13:00-14:00 – Networking lunch (Exhibitors Area)
12:40 – 13:00 – Sponsored Spotlight Presentation
Take this unique opportunity to be a part of the event theme, network, share ideas, new trends and provide an overview of your product/services to the audience. For more information please contact: Ronald R. Magali
14:00-14:40 – Safety Assessment of Leachable Substances from Container Closure Systems – Pre-filled Syringes
• The need for safety assessment of leachables will be discussed
• Approaches and considerations to establish biological safety will be outlined.
• Working examples will be presented
Stephen A. Barat, Ph.D. Senior Director, Toxicology and Operations Experimental Medicine and Science, Forest Research Institute, A Subsidiary of Forest Laboratories, Inc.
14:40-15:20 Investigation of leachables and extractables
• Risk assessment of leachables and extractables
• Process improvement for investigation
15:20-16:00 – Networking – Afternoon Refreshments
16:00-16:40 – Introduction to Cyclic Olefin Polymer
• Key properties and features of COP & its benefits for Pre-filled syringe applications.
• Mechanical properties after exposure to gamma, steam, EOG and cryogenic temp.
• JP, US, EU Pharmacopoeia and ISO 10993 status.
• Moisture/Gas barrier data.
• Residual metal and outgas data.
• COP marginal stress data vs. various chemicals.
• Protein Adsorption study with BSA. Insulin, IgG
• EB & Gamma irradiation -color shift study.
• Comparative mechanical properties of COP vs. COC.
Toshiro Katayama, Product Manager, New Business Dev, Zeon Chemicals L.P.
16:40-17:20- Fill – finish for prefilled syringes in a contract manufacturing setting with the following emphasis
• CMO client partnership – conclusion highlighting best practices
• Client Teams dedicated to your product by knowledgeable individuals
• Metrics to drive performance – leading indicating metrics; tangible output translating to a timely deliverable
17:20-17:30 – Chairman’s comments
Noxilizer has a unique and superior, room temperature NO2-based sterilization technology that is revolutionizing two major sterilization markets — medical device/pharmaceutical/biotechnology manufacturing and hospitals. In the manufacturing market, Noxilizer provides sterilization services for medical devices and drug/device combination products. Noxilizer sells the RTS 360 Industrial NO2 Sterilizer to companies who sterilize products in-house and also offers contract sterilization services. In hospitals, Noxilizer is developing a system especially for sensitive, high-tech equipment used in minimally-invasive surgical procedures. Noxilizer is headquartered in Baltimore, MD with offices in the US and Japan. Noxilizer, Inc. is privately held and was founded in 2004.
Achieve glass-like transparency and excellent long-term stability for protein and peptide based drugs by using ZEONEX. ZEONEX cyclo-oleflin polymers, break resistant plastics designed for critical pharmaceutical packaging applications including vials, pre-filled syringes, and blister packaging. ZEONEX COP is an ultra-clean plastic that does not contain additives or components that leach-out over time. Additionally, for protein-based drugs, common proteins show low adsorption onto ZEONEX containers as compared to other plastics.
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