Dublin, Feb. 04, 2019 (GLOBE NEWSWIRE) -- The "Pre-filled Syringes Conference 2019, Innovations & Developments : A Decade at a Glance" conference has been added to ResearchAndMarkets.com's offering.
Prefilled syringes (PFS) constitute one of the fastest growing segments of the injectable drug delivery device market. The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being. A prefilled syringe is defined as a single-dose packet of vaccine to which a needle has been fixed by the manufacturer. Typically metal and glass have been common in the past, however there has been a shift towards plastic and disposable syringes, so the needle is protected and cannot be reused (prefilled disposable systems).
Estimates show that the global prefilled syringes market, is likely to reach sales of 6.9 billion by 2018, growing at a compound annual growth rate of 13.8% from 2012 to 2018. Many examples of drugs packed into prefilled syringes are vaccines, blood stimulants, therapeutic proteins, erythoprotein.
The pharmaceutical market promises high potential for prefilled syringes, however production costs are high and manufacturing is complex. Industrial pressure arising concerning pharmacovigilance and reducing cost suggest there are still challenges to overcome.
Why you should attend this conference:
- Understand current market dynamics: prospects for the future
- Analyse manufacturing options ready to fill vs bulk syringes
- Explore approaches to ensure drug identity, potency and sterility
- Utilise strategies to ensure quality and safety of prefilled syringes
- Ensure pharmacovigilance practices
- Investigate compatibility issues: avoiding changes in product quality
- Overcome regulatory and technical hurdles
- Discover novel prefilled syringe technology
Who Should Attend:
Those working in the area of pre-filled syringes with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance and combination products. Drug delivery specialists, business development managers and product development managers will also find this course beneficial. It will provide a good comprehensive overview for those new to the field and those who require a refresher.
Agenda:
Day 1
08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues.
09:30 - Chairperson opening remarks
Sabrina Daw, Commercial Director, Lexicorp
Innovations & Developments: A Decade at a Glance
Development & Enhancement in Design & Manufacturing
09:40 - EU regulation of pre-filled syringes
09:40 - Prefilled Syringes and Packaging
What should the role of development in design manufacturing be?
What should the role of enhancement in design manufacturing be?
Device testing development, sampling plans
Automated testing process
10:20 - Digital Health for Drug Delivery
- How will digital technologies transform drug delivery
- Key considerations in the design and development of solutions
- Regulatory opportunities and challenges in the digital health space.
- Conclusions/Discussion
11:00 - Morning Coffee/Tea & Discussion
11:30 - Risk mitigation strategies and documentation for extractable, leachable and interactions in PFS
Choice of critical components for drug compatibility in PFS
Relationship between extractables, simulated leachables and leachables in PFS
Predictive tools for interactions in PFS
Develop Case studies between leachable assessments in pre-filled syringes
CARSTEN WORSOE, Principal Scientist, NovoNordisk
QUALITY & SAFETY OF PRE-FILLED SYRINGES
11:50 - Enhancing prefilled syringe compoenent quality
Assessing quality
What are the quality measures in prefilled syringe design
Are there levels of regulation
Consulsions/discussion
BRAM JONGEN, Head of R&D , Datwyler Sealing Solutions
12:30 - Networking luncheon
Safety Challenges related to prefilled syringes
13:40 - Panel Discussion - The safety challenges in relation to prefilled syringes
- Pre-filled syringes make injections easier and safer for both doctors and patients
- Pharmaceutical companies can benefit from less overfill in pre-filled syringes
- Pre-filled syringes work well with increasingly popular safety devices and auto-injection systems
- Pharmaceutical companies must be able to ensure patient safety by demonstrating that no component or material has any extractables and leachables (E&L) and that the primary packaging doesn't have an adverse interaction with the drugs.
- Pre-filled syringes, are in contact with not only the drug, but more materials and components-creating additional opportunities for interactions and E&L.
Panelists:
FRANZ KAINZ, Vice President, Sterile Contract Manufacturing Services, Fresenius Kabi
14:20 - Clearance and approval designs considerations
Clearance procedures
Approval Design Considerations
What are regulators looking at?
Trends and challenges
Andrew Fielden, Chemistry Operations Director, Smithers Rapra Ltd
15:10 - Afternoon Tea/Coffee
15:30 - Industrial termination sterilization of heat and radiation senitive products by low temperature VHP (Vaporized Hydrogen Peroxide)
Explaining low temperature VHP
Aspetic packaging processes
New developments in industry
AMIT KHANNA, Application Project manager, Team Lead, STERIS
16:10 - The future of safety systems for pre-filled syringes, with case study
Impact of safety for pre-filled syringes
What is new in relation to safety systems
Case study
16:50 - Chairperson's closing remarks and end of conference
17:00 - 18:00 - Networking Drinks Session
Day 2
08:30 - Coffee and registration - An opportunity to meet and to network with your conference colleagues.
09:30 - Chairperson opening remarks
Sabrina Daw, Commercial Director, Lexicorp
REGULATORY CONSIDERATIONS & COST EFFICIENCY
09:40 - EU regulation of pre-filled syringes
Impact of the MDR for pre-filled syringes
What is new in relation to the MDR
How pre-filled syringes manufacturers should prepare for the new MDR
FABIEN ROY, Counsel Life Sciences , Hogan Lovells
10:20 - Formulation aspects in PFS development of biologics
Compatibility with syringe material
Stability
Conclusions
10:50 - Morning Coffee/Tea & Discussion
11:10 - International recommendations and regulations for successful drug approval
Importance of Successful Drug Approval
Communication best practices
International recommendations
International regulations
Considerations for successful drug approval practices
Moderator:
FRANZ KAINZ, Vice President, Sterile Contract Manufacturing Services, Fresenius Kabi
11:50 - Connected Medical Devices
Trends & Benefits of connected Medical Devices
Regulatory Strategy & Hurdles
What Benefits of Connected Devices for Patients, Caregivers and Insurance
12:30 - Networking luncheon
CURRENT MARKET DYNAMICS PROSPECTS FOR THE FUTURE
13:30 - Benefits and hurdles of device development
Implementation and maintenance development
Benefit of device development
What should we learn from previous hurdles
New approaches to managing device development
Moderator:
Andrew Fielden, Chemistry Operations Director, Smithers Rapra Ltd
Panelists:
STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation
14:10 - A prefilled syringe commercialization strategy
What are the current impacts commercialization
Commercial Success of 3rd Generation Digital-Auto Injector
Considerations for:- Sustainability and Environmental Impact
STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation
14:50 - Connected Health and regulated combination products
Analysis of market
Market Dynamics
Market Demographics
Neil Williams, Director Front End Innovation-head of Connected Health, Medicom innovation Partner Ltd
15:20 - Afternoon Tea/Coffee
15:40 - Consider design factors and material selection
PFS Market Designs
Design Factors
Material Selection
Do we learn from previous experiences?
MAX CAMBRAS, Strategic Advisor in Life Sciences, L.E.K Consulting
16:20 - Panel Discussion: Evaluate new technology and market development
Current manufacturing practices in the EU & US
Enhancing communication between regulators, regional authorities and manufacturers
Evaluate new technology
Evaluate market development
STEVEN LYNUM, President and Member of the Board of Directors, Panasonic Healthcare Corporation
17:00 - 17:10 - Chairperson's closing remarks and end of the conference
For more information about this conference visit https://www.researchandmarkets.com/research/mxd565/prefilled?w=12
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