Conference on 3rd Pre-filled Syringes

Conference on 3rd Pre-filled Syringes
Innovative solutions for injection devices and parenteral packaging systems

25th - 27th October 2010,
BSG Conference Centre, London, UK

Key Speakers

Todd Stephens, Global Marketing Director, Merck Serono,
Stefan Sundström, Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems, AstraZeneca,
Ian Thompson, Director of Business Development, Ypsomed,
Klaus Ullherr, Product Manager, Packaging Technology, Robert Bosch Packaging,
Jim Spolyar, Sales and Technical Director, Skan US,
Gabriele Peron, Marketing Manager, Stevanato Group - Glass Division,
Thomas Zelmer, Director, Groninger,
Sterling Kline, Director of Project Development, Integrated Project Services,
Shawn Kinney, Chief Executive Officer, Hyaluron
Elliot Lawrence, Associate Director of Regulatory Affairs, ERA Consulting,
Daniel Wheeler, Lecturer in Anaesthesia, University of Cambridge,
Andrew Longworth, General Manager, KÖRBER MEDIPAK UK & RoI.

Conference Introduction

With more injectable biological drugs in use than ever, the pre-filled syringes market will sustain its inexorable growth, with total revenues of $6bn by 20251.

Whether your interests lie in drug formulation, sterile manufacturing or strategic partnering,
attending this conference will enable you to:

• Overcome challenges arising from silicon-drug solution interaction
• Troubleshoot heavy-metal induced drug precipitation and microbiological contamination
• Improve dosing accuracy and enhance patient compliance with next-generation electronic devices
• Learn about novel pre-fi lled syringes for biotech products and auto injector devices
• Understand pre-fi lled syringe processing with RABS, isolators, E-beam and alternatives
• Examine factors and recent developments in processing syringe nests
• Analyse new developments in COC, COP, glass, and elastometric components
• Offset the impact of extractables and leachables on product performance
• Assess the impact of new post-market surveillance regulations on pre-filled medical devices
• Develop new strategies to remain competitive
• Obtain the latest market analysis, and meet manufacturers showcasing their leading products.

Who should attend

Presidents, Chief Executives, Chief Scientific Officers, Chief Operating
Officers, Vice Presidents, Heads, Directors, Clinicians, Principal Scientists,
Managers, Project/Team Leaders in:
• Packaging and labelling
• Vaccine, antibody and protein manufacturing
• Product design
• Technical support
• Drug product process development
• Drug device process development
• Formulation sciences
• Safe medication practice
• Drug discovery & delivery
• Clinical product resourcing
• Supply outsourcing
• Contract manufacturing and management
• Process development
• Strategic alliances
• Investment and venture capital

3rd Pre-filled Syringes
Pre-Conference Interactive Workshop

Monday 25th October 2010

About the workshop:

The session will overview the legal and regulatory issues applicable to pre-filled syringes and some of the more pressing or challenges concerns regarding their sale and use. These will include:
• Product liability
• Reuse
• Control of supply and distribution chains (including parallel imports, pharmacovigilance and post marketing surveillance)
• A regulatory overview

About the workshop leaders:

Alexander Denoon
Alex has both a science degree (human genetics) and a law degree. He qualified as a solicitor (in Australia) in 1995. Alex spent more than five years in- house, including as general counsel and company secretary of Biotech Australia.Alex advises clients in relation to the development of strategies for the protection, defence and commercialisation of intellectual property. This involves the development of strategies and the drafting of a wide array of commercial agreements from licenses to joint ventures. Alex also advises in relation to the regulation of pharmaceuticals, medical devices and advanced therapy medicinal products. Alex has a breadth of international experience structuring, negotiating and drafting commercial agreements. Both as a corporate advisor and as in house counsel.

LDD was established to focus on advising clients in the Life Sciences sector – namely the pharmaceutical, medical devices, reproductive and regenerative medicine industries. Together we bring more than 25 years experience advising clients in the sector. Our particular areas of legal expertise include regulatory matters, compliance programmes, public law and judicial review, intellectual property, commercial contracts and due diligence.

Erik Vollebregt
Erik’s practice focuses on (medical) technology, marketing, healthcare and life sciences. He has broad experience both in litigation and in transactional work in these areas, as well as in the application of anti-trust law to high technology and pharmaceutical products.

Mathias Klümper
Mathias worked as a lawyer and core member of the industry group “Healthcare, Life Sciences and Chemicals” at the Düsseldorf office of Clifford Chance from 2004 until 2008. He advised clients from the pharmaceutical, medical device and biotechnology industry in all regulatory matters. He focused on advising clients on healthcare fraud and abuse prevention (business compliance) and the implementation of employee guidelines and processes. He does not only know the perspective of a lawyer but also obtained a comprehensive insight into the in-house perspective within two client secondments in the European legal department of an international medical device company in Switzerland and a German pharmaceutical company. He is author of a number of publications on regulatory themes relating to pharmaceuticals and medical devices as well as co-author of the “Handbuch des Arzneimittelrechts” (textbook on pharmaceutical law, in prep.). Furthermore, he holds lectures and speeches on current subjects from the pharmaceutical and medical device area.

Day 1
Tuesday, 26th October 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Technology advances and market trends for auto-injectors
• User benefits.
• Creating and protecting market share.
• A new generation of device and compromises in device design.
• Future opportunities.

Ian Thompson
Director of Business Development, Ypsomed,

10:20 Achieving extra high quality production of glass primary packaging: building a manufacturing concept flow based on a streamlined process
• OMPI case study / optimised process
• Defining criteria for excellence in glass containers for pharmaceutical products
• Successfully managing critical aspects (particle control, high tolerances, contact free, silicon, traceability)

Gabriele Peron
Marketing Manager, Glass Division, Stevanato Group,

10:40 Opportunities and challenges for novel primary drug containers in autoinjectors
• Analysis of suitability and weaknesses of current syringe platforms for use in autoinjectors
• Opportunities and challenges for cyclic olefins in novel primary drug containers for autoinjectors
• One approach: Oval’s novel primary drug containment technology

Matthew Young, Chief Executive Officer, Oval Medical Technologies.

11:00 Morning refreshments

11:20 Preserving form and functionality when dealing with sensitive molecules
• Understanding product-packaging interactions to reduce denaturation and aggregation
• Recovery challenges for high concentration formulations
• Avoiding product loss through effective monitoring

12:00 Negating the effects of heavy metal contamination on product stability
• Effects of tungsten and iron on product behaviour in solution
• Considerations when dealing with high concentration formulations
• Strategies to optimise colloidal stability

12:40 Networking lunch

14:00 Microbiological and particulate contamination risks in the manufacture of parenterals
• Elucidating contaminant dispersion routes when producing parenterals
• Risk-based methods to evaluate contamination risks
• Methods for calculating contamination risks (to determine viability and non-viability)

Stefan Sundström,
Director, Sterile Aseptic Manufacturing, Engineering and Maintenance, Technical Lead Sterile Process Systems, AstraZeneca,

14:40 Pre-filled syringe processing with RABS, isolators, e-beam & alternatives
• Isolator technology with latest E-Beam design features
• Comparison of RABS vs Isolators
• Expansion of the areas of application of syringe technology

Jim Spolyar,
Sales and Technical Director, Skan US,

15:20 Afternoon refreshments

15:40 Minimising the risk of sterility breach from stopper movement
• Intra-syringe gas bubble movement permits breach of product sterility
• Determining the maximum allowable gas bubble for a given syringe
and stopper combination using a risk based approach.

Shawn Kinney,
Chief Executive Officer, Hyaluron,

16:20 Panel discussion: Improving performance and reliability in pre-filled devices- where are we and what are the prospects for the future?

Topics discussed will include overcoming siliconisation and drug precipitation, how materials science can aid primary packaging design,
maintaining sterility and ensuring stability.

17:00 Closing remarks from the chair

17:10 Networking drinks
Take your discussions further and build new
relationships in a relaxed and informal setting.

Day 2
Wednesday 27th October 2010

09:00 Registration and refreshments

09:30 Opening address from the Chair

09:40 Stopper insertion methodology and shelf-life longevity
• High-speed filling equipment and online stopper insertion
• Online high-speed filling and offline vacuum stoppering
• Eliminating stopper movement

Thomas Zelmer
Director, Groninger,

10:10 Why we need pre-filled syringes (but might not be getting them...)
• Drawing up drug solutions is fraught with risks to patients
• Mistakes are common and medication errors are frequent
• Pre-filled syringes address many, but by no means all, of these issues
• Reports of the death of the ampoule may have been greatly exaggerated...

Daniel Wheeler,
Lecturer in Anaesthesia, University of Cambridge,

10:50 Morning refreshments

11:10 The impact of advanced aseptic technology on facility design
• Harmonisation of EU and FDA guidance for room classifications
• Isolators versus RABS risk and cost impact
• Recent case studies

Sterling Kline
Director of Project Development, Integrated Project Services,

11:50 Future oriented processing of nested syringes
• FXS 5100 high-performance machine with output of up to 600 syringes per minute
• Innovative line concept for fully automated processing of pre-sterilized, pre-filled nested syringes
• Integrated automatic bag and tub openers

Klaus Ullherr,
Product Manager, Packaging Technology, Robert Bosch Packaging,

12:30 Developments in the secondary packaging of pre-filled syringes
• Identify the principal requirements of a package for pre-filled syringes
• Identify two alternative methods of packaging pre-filled syringes
• Identify features and benefits of both systems
• Identify future trends in the packaging of pre-filled syringes

Andrew Longworth,
General Manager, KÖRBER MEDIPAK UK & RoI,

12:50 Networking lunch

14:10 Next generation injection devices for high-cost, long-term medications
• Improving compliance to injectable therapies- a ongoing challenge
• Easypod: an empowering, patient-friendly option
• Applications to growth hormone, multiple sclerosis and fertility treatments

Todd Stephens,
Global Marketing Director, Merck Serono,

14:50 Best practices on current and future demands on finishing
• Validating unit operations
• Ensuring resilience during transportation
• Maintaining photostability to preserve product quality

15:30 Afternoon refreshments

15:50 Regulatory issues versus requirements for biological medicinal products in pre-filled syringes
• Overview of the regulatory requirements and guidelines
• Data package required
• Case studies: potential issues to consider

Elliot Lawrence
Associate Director of Regulatory Affairs, ERA Consulting

16:30 Chair’s closing remarks

16:40 End of conference.

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