World of Pre-filled Syringes & Injectable Devices Europe 2013

SL51

Background Info


World of Pre-filled Syringes & Injectable Devices Europe 2013

As the pharmaceutical market develops, the role of drug delivery in conjunction with the pharmaceutical product itself, increases in importance. Pre-filled syringes are an important part of the landscape which
pharmaceutical companies need to be aware of.

There are several obstacles to creating an effective pre-filled syringe product line, not least because it is composed of several different layers, i.e. the packaging, the syringe, the product, and the pharmaceutical ingredient. Plus of course, as a relatively new entrant into the marketplace, there are commercial and regulatory aspects to consider as well.

This 2-day conference will enable delegates to look at the end-to-end supply chain of pre-filled syringes, from the manufacturing to the logistics. The event will also cover some of the latest hot issues in pharmaceutical manufacturing, such as quality-by-design, and problems with technology transfer and scale-up.
Finally, the physical nature of the pharmaceutical product and the ramifications of its interaction with the syringe itself are an important issue: what difference does it make if it is a biotech drug for example? These will be discussed at length in this event.

Join us for two days of insights, case studies and discussions on pre-filled syringes.

Event Highlights

DAY ONE
– 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?

DAY TWO
– 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
Understanding the challenges involved for a win-win partnership

“Over the last two decades there has been an increase in the administration of parenteral drugs by prefilled syringes and injectable devices. The worldwide market for prefilled syringes alone is estimated at 1,500 billion units and worth US $1.5 billion???

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 of tomorrow

Who should attend?
VPs, Directors, Heads, Managers of Pharmaceutical & Biotech companies
• Packaging and Labelling
• 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
• Analysts
• Consultants
• Researchers
• Lawyers
• Partners and senior counsel

Key Speakers



Day 1


Day 1 – 10th September 2013

09:00-09:30 – Registration & Coffee

09:30-09:40 – Chairman’s welcome & opening remarks

09:40-10:20 – The current market for prefilled syringes and future trends
• Realising the present demand for new, innovative drug delivery methods
• Understanding the move towards better technology to improve drug delivery and its ramifications

10:20-11:00 – Regulatory Aspects of Prefilled Syringes in Europe
• Pre-filled syringe: medicinal product or medical device
• Borderline Examples
• Auto-injectors
• Module 3: Quality – including special focus on the Manufacturing Process, Container Closure aspects
• Agency feedback: Licensing
• the Regulatory Horizon
• Future MAA trends: Rapid Micro Methods

11:00-11:40 – Morning Refreshments (Networking)

11:40-12:20 – A Novel Point of Care Device for the Diagnosis of Ovarian Cancer using a Pre-filled Syringe
• Current status of ovarian cancer diagnosis Biomarker discovery from ovarian cyst fluid Validation studies Development of a point of care diagnostic device using a pre-filled syringe
Dr. Khalil Razvi, Gynaecologist, Director for Women and Children, Southend University Hospital

12:20-13:00 – Development Considerations for Biologics as Pre-Filled Syringe Products: A QbD approach
• Quality by design and its role in pre-filled syringes
• Process improvement and quality management
• Quality Attributes for Pre-filled syringe products that are of concern
• Component Selection and Risk Assessment
• Co-development with Component Manufacture
• Taking these lessons and making immediate improvements

13:00-14:00 -Networking Lunch

14:00-14:40 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?

14:40-15:20- 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.

15:20-16:00 – Afternoon Refreshments (Networking)

16:00-16:40- New Sterilization Solution for Prefilled Syringes
• Continued education on current and new sterilization processes
• Understanding of the benefits and limitations of nitrogen dioxide sterilization; and
• Allow attendees to become a resource to their organization on the challenges and solutions of sterilizing prefilled syringes.
Dr. David Opie, PhD Sr. Vice President, Research and Development Noxilizer, Inc.

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
• Method 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

17:30-Networking Drinks Reception
Take your discussions further and build new relationships in a relaxed and informal settings

Day 2


Day 2 – 11th October 2013

09:00-09:30 – Registration

09:30-09:40 – Chairman’s welcome (Opening Remarks)

09:40-10:20 – Prefilled syringes and highly concentrated liquid protein formulations (HCLF)
• Challenges with HCLF
• Stability issues and formulation
• Counteraction with packaging

09:40-10:20 – Product-container interaction: the impact on the drug
• Why product-container interaction is to be avoided
• Lessons in avoiding immunogeneticity
• Will new materials/technologies help with the issue

10:20-11:00 – Networking – Morning Refreshments

11:00-11:40 – Pre-filled syringes and biotech drugs
• The current market for biotech drugs
• Future possibilities for pre-filled syringes and biotechs

11:40-12:20 – Fill/Finish Scale-up and Technology Transfer
• Quality by Design and a streamlined process
• Understanding the hurdles with up scaling
• Effective technology transfer

12:20 -13:00 – PANEL DISCUSSION: Quality by design in manufacturing for pre-filled syringes: challenges and opportunities

13:00-14:00 – Networking Lunch

14:00-14:40 Extractable and Leachable Testing for Pre-filled syringes
• Origins of extractable and leachable
• Understanding regulatory requirements and industry best practice
• E&L testing
Michael Creese, Manager, Project Management, Smithers Rapra

14:40-15:20 – Extractable and Leachable risk mitigations in Pre-filled syringes
• Risk assessment in extractable and leachable in PFS
• Critical component selection in PFS system
• How to set-up extractable and leachable studies for PFS
• Experience with glass v. plastic PFS
• Case studies on extractable and leachable in PFS system
Carsten Worsoe, Principal Scientist, Novo Nordisk

15:20-16:00 – Networking – Afternoon Refreshments

16:00-16:40- 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 vapour
Jim Spolyar, Sales and Technical Director, SKAN US INC

16:40-17:20 – The Closed Vial Technology to address two main issues of Aseptic Filling
• The risk for the patient
• The complexity of aseptic filling
• Advantages of aseptic filling
• Simplification of the process to completely re-shaped manufacturing process
Benoit Verjans, Scientific Advisor, Aseptic Technologies

17:20-17:30 – Chairman’s Closing remarks

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