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1. 4th Pre-Filled Syringes
Addressing the multifaceted challenges for efficacious products
17th – 19th October 2011, Visiongain Conference Centre, London, UK BOOK NOW!
Key Speakers
Dr Andrew Feilden, Senior Scientist, AstraZeneca
Dr Wolfgang Papst, Device development, Novartis
Dr Christian Vogt, QA/QC Expert Microbiology, Novartis
Dr Torsten Richter, Project co-ordinator, Bayer
Dr Vikas Jaiteley, Pharmaceutical Assessor and Deputy Manager, MHRA
Norman Gray, Inspector, MHRA
Klaus Ullherr, Product Manager, Robert Bosch Packaging
Horst Koller, Regulatory Affairs, Schott
Senior Representative, Groninger & Co
Patrick Grueninger, Global Marketing & Business Development Manager, Helvoet Pharma
Dr Jan Jezek, Chief Scientific Officer, Arecor
Matthew Young, CEO, Oval Medical Technologies
Liz Fuller, Partner, Bird & Bird LLP
Paul J Cummings, Executive Director, PJC Pharma Consulting
Frank Ellwood, CT Superintendent, NHS
Dr Stephen Barat, Senior Director, Toxicology and Operations, Forest Research Laborotories
Pre-conference Workshop, Monday 17th October, 2011
Extractables and Leachables
Led by: Dr Andrew Feilden, Senior Scientist, AstraZeneca
Associate Sponsor
Organised By
Driving the Industry Forward | www.futurepharmaus.com
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/syringes

2. Conference Introduction
4th Pre-Filled Syringes
17th - 19th October 2011, London, UK
Dear Colleague, Associate Sponsor:
SCHOTT Pharmaceutical Systems is one of the world’s
re-Filled syringes constitutes one of the fastest growing markets in the drug delivery
P leading suppliers of glass tubing and primary packaging
and packaging sectors with total revenues in this market expected to reach $5.5bn in for the pharmaceutical industry. We provide our customers
20251. This is driven by a marked rise in the success of biological drugs and vaccine quality solutions while meeting their highest demands with
market expansion. our material expertise, specialized analytical lab services, and a broad product
ith the prospect of easier administration, reduced risk of detrimental occurrences and
W portfolio; including syringes, cartridges, vials, ampoules, and special articles made of
cost-effectiveness, its no wonder Pre-filled syringes are fast becoming the drug delivery glass and COC polymer. With four glass tubing production sites and fifteen sites for
system of choice. pharmaceutical packaging spread over four continents, we offer safe supply and local
service. Our state-of-the-art production facilities and our products comply with the
oin us at Visiongain’s 4th Pre-filled syringes conference and gain insight into a
J highest international quality standards for pharmaceutical needs.
spectrum of topical issues ranging from manufacture, formulation and drug identity to For further information please visit: www.schott.com
quality, safety and novel pre-filled syringe technologies.
on’t miss this wonderful opportunity to further your knowledge in an interactive
D Media Partners:
learning environment and network with diverse leaders in the industry! PharmiWeb.com is the leading industry-sponsored portal for
the pharmaceutical sector. Supported by most of the leading
Reasons to register today: pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features,
• Understand current market dynamics: prospects for the future events listings and international jobs to industry professionals across Europe and the US.
For further information please email: corporate@pharmiweb.com
• Analyse manufacturing options: ready to fill vs bulk syringes
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD.
• Inspect formulation issues It is based and located in Warsaw, Poland. Biotechnology World
was founded in 2007 to provide the world’s biotech and pharma information and market
• Gain advice on overcoming regulatory and technical hurdles to make it universally accessible and useful for scientific and business processes. Its first
• Investigate compatibility issues: avoiding changes in product quality step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will
allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers
• Explore approaches to ensure drug identity, potency and sterility companies completed internet public relations, publication and marketing solutions. One of
the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector
• Survey end user compliance: implications, requirements and opportunities in Europe to global biotechnology, pharmaceutical and life science activities.
• Utilise strategies to ensure quality and safety of prefilled syringes For further information please visit: www.biotechnology-europe.com
Driving the Industry Forward | www.futurepharmaus.com
• Explore pre-filled syringes for leachables: the suitability for use issues Future Pharmaceuticals has forged powerful relationships with key
industry leaders to provide a platform for successful brand recognition,
• ain insights in to the healthcare professional’s perspective: problems at the
G and for senior decision-makers to have the means to procure and plan implementation
forefront strategies based on the topics covered. Positioned to be an authoritative resource within top
• Discover novel pre-filled syringe technology pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is
geared to create a deep penetration into a highly targeted and responsive audience, bridging the
I look forward to meeting you at the conference gap between the industries’ top issues and the solutions top-tier vendors can provide.
Best regards
For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical news,
comment, contracts, services, jobs and events and is home to
InPharmjobs.com, Pharmafile and Pharmafocus.
For further information please visit: www.inpharm.com
Nima Farah
Conference Producer
Poster Presentation
At a busy conference it is hard to make sure everyone who shares your interests knows
what you are doing. Maximise your time at Visiongain’s 4th Pre-Filled Syringes meeting by
sharing your results in a poster presentation. With a plethora of key decision makers, take
advantage of this senior networking opportunity.
Who should attend? Please send your 200 word abstract, in English, to: info@visiongainglobal.com for
Presidents, Chief Executive Officers, VPs, Global Heads, Chief approval. The deadline for submissions is Wednesday 28th of September 2011. Please
Scientific Officers, Directors, Principal Scientists, Franchise Heads and include contact details for the corresponding author(s).
Investigators in: Academic institutions will not be charged a fee if booked as full-price delegates. Posters
• High-Throughput/High-Content Screening Operations submitted by pharmaceutical and biotechnology firms will be charged a fee of £199.
• Bioanalytical Development Posters submitted by service providers / vendors are welcome and will be subject to
• Compound Profiling evaluation. Upon approval a fee of £500 will apply. Two delegates from your organisation
must be booked at full price to present a poster.
• Drug Discovery/Validation
• Cellular Imaging Please note that all posters will be displayed at the discretion of Visiongain Ltd and are
• Lead Generation subject to approval. Due to limited space, please register your interest early.
• In Vitro Sciences
• ADMET
• Pre-clinical Development Sponsorship and exhibition opportunities
• Medicinal Chemistry This event offers a unique opportunity to meet and do business with some of the key
• Toxicology players in the pharmaceutical and biotech industries. If you have a service or product to
• Stem Cell Technologies & Platforms promote, you can do so at this event by:
• Pharmacovigilance and Safety Testing • Hosting a networking drinks reception
• Chemistry and Bioapplications • Taking an exhibition space at the conference
• GPCR/Kinases/Molecular Pharmacology • Advertising in the delegate documentation pack
• External/Contract Research • Providing branded bags, pens, gifts, etc.
• Pharmacokinetics/Pharmacodynamics If you would like more information on the range of sponsorship or exhibition possibilities
• Cellular Research and Development for visiongain's 4th Pre-Filled Syringes Conference, please contact us:
• Business Development Damian Gorman, +44 (0)20 7549 9934
• Investment and Venture Capital
damian.gorman@visiongainglobal.com
Pre-Filled Syringes and Related Systems: World Market Outlook 2010-2025, VISIONGAIN
1

3. Pre-Conference Interactive Workshop
4th Pre-Filled Syringes
Monday 17th October 2011
Extractables and Leachables
Led by: Dr Andrew Feilden Timings: 9:30 - 10:00 Coffee & Registration
0
Senior Scientist 10:00 - 15:00 Workshop
AstraZeneca T
iming includes lunch and refreshment breaks
About the workshop About your workshop leaders:
The purpose of the workshop is to allow you to engage in knowledge
Dr Andrew Feilden
sharing with your peers in a smaller, less formal environment than the
main conference. As such, the audience size will typically be no more
Dr Andrew Feilden, is currently a senior scientist within Analytical
than 20 participants in order to enable maximum interaction between
the workshop leaders and the delegates. The format is also more Science at AstraZeneca Charnwood, has been working in the field of
interactive, with less emphasis on ‘lecture-style’ presentations and more
trace analysis using hyphenated techniques such as GC-MS and LC-MS
emphasis on group discussions, exercises and Q&A sessions.
for over 12 years. Andrew currently leads the extractable and leachable
Agenda:
testing within AstraZeneca and is an active member of both the IPAC-
• Introduction
RS container closure group and is the co-chair of ELSIE material group.
• Regulatory Requirements
Andrew gained a degree and D.Phil from York University. Andrew will be
- Current guidelines, recommendations and best practises
• How to carry out extractable and leachable testing moving to join Smithes Rapra in June 2011 as a Principal Consultant.
- Types of studies
- Techniques to use
About visiongain:
Visiongain is a specialist business information company focused on providing
- Limits of detection required cutting edge products and services across the Pharmaceutical/Biotech,
Telecommunications, Defence and Finance sectors, which include reports,
conferences, online daily news and offline news analysis and bespoke
• Industry working groups
consultancy. With a commitment to innovation and excellence, visiongain
offers flexible solutions to meet our clients’ business intelligence needs,
- What groups are there and what are they doing providing the right information at the right time to facilitate the commercial
decision-making process. Our pharmaceutical products include Pharma
• Hypothetical E&L Case Study Business Daily, the leading daily email newsletter for the pharmaceutical,
biotech and healthcare industries, and a range of independent, high-
quality, in-depth reports covering focused and topical areas of concern. Our
• Extractable and leachable risk assessment pharmaceutical conferences address the hottest commercial, regulatory and
technical topics and provide an ideal forum for debate and networking for
• Change management pharmaceutical professionals from around the world.
For further information, please visit: www.visiongain.com

4. Day 1
4th Pre-Filled Syringes
Tuesday 18th October 2011
09:00 Registration and refreshments 13:40 Pre-filled syringes: the regulatory aspects
• Overview of regulatory requirements
09:30 Opening address from the chair • Review latest developments
• How to meet requirements
• Case Studies
09:40 Formulation development and product image
Dr Vikas Jaiteley
• Target product profile and key marketing targets
Pharmaceutical Assessor and Deputy Manager
• Specific formulation issues MHRA
• The pharmacist/Nurse/Practitioner angle
• Stability assessment 14:20 Overcoming regulatory and technical hurdles: the
• Product differentiation, the medicines vision legal perspective
• Future plans • Regulatory challenges within:
- Formulation
Paul J Cummings - Stability
Executive Director - Clinical
PJC Pharma Consulting Ltd - Filling
• Overview of technical challenges
10:20 Manufacturing options • Summary
• Ready to fill vs bulk pre-filled syringes: Liz Fuller
- Comparison of manufacture process Partner
Bird & Bird LLP
- Pros and cons
• Glass vs plastic pre-filled syringes:
15:00 Afternoon refreshments
- Reaching a decision
- Pros and cons 15:20 Extractable and Leachable studies for pre-filled
- Alternative primary packaging syringes: how to step-up the right testing strategy?
• hat is the importance of extractable/leachable studies (safety,
W
11:00 Morning refreshments regulatory requirements)
• ow can supplier information assist you in the design of an extractable
H
study and what pitfalls should be avoided
11:20 Microbiology in filling and sterility test isolators
• How to assess the results of an extractable study
• Bringing an isolator under microbiological control • How to carry out a leachable study, how to assess these results
• How to achieve a state of “practically free of micro-organisms” • Case studies
• Control of an isolator with physical and microbiological monitoring Dr Piet Christiaens
• Maintenance aspects and integrity checks of isolator systems Scientific director
• Validation of an filling isolator with media fills Toxikon Europe
• Microbiological problems in isolators
16:00 Toxicological assessment of leachables from
Dr Christian Vogt
container-closure systems: pre-filled syringes
QA/QC Expert Microbiology
• Brief overview of leachables and extractables
Novartis
• ackground on the need for safety evaluation of leachables from
B
container closure systems
12:00 Small batch filling applications • urrent initiatives and regulatory expectations related to leachable
C
• Filling of high potent drugs safety assessment
• Working examples/case studies
• Disposable filling system including introduction in to cleanroom area
• Process improvements fill/finish Dr Stephen Barat
Senior Director, Toxicology and Operations
• Automation of critical process steps
Forest Research Institute, A subsidiary of
• Barrier systems including mock-up Forest Laborotories
• Innovative fill/finish concepts for new pre-sterilised containers
Klaus Ullherr 16:40 Closing remarks from the chair
Product Manager
Robert Bosch Packaging
12:40 Networking lunch 16:50 Networking drinks
Take your discussions further and build new
relationships in a relaxed and informal setting
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011

5. Day 2
4th Pre-Filled Syringes
Wednesday 19th October 2011
09:00 Registration and refreshments 14:20 Pre-filled syringe technology
Senior Representative
09:30 Opening address from the Chair Groninger & Co
09:40 Advanced elastomeric components for 14:40 Presentation to be announced
pre-filled syringes Horst Koller
• Special concerns for elastomeric components Regulatory Affairs
• Impact on material development Schott
• Impact on component design
• Advanced coating technology Omniflex CP
15:00 Afternoon refreshments
• Standardisation of elastomeric PFS components
Patrick Grueninger
15:40 CT Radiographers’ Perspective (thoughts from the
Global Marketing & Business Development Manager
Helvoet Pharma coal face)
• How do we use pre-filleds in a CT department
10:20 Visual inspection in pre-filled syringes - Iodinated contrast media
• Requirement of inspection - Intravenous injection via pump injector
• Manual/semi-automated/automated inspection
• Clinical task
• Insights into inspection environment and process for prefilled syringes
• Case study - Number and range of scans
Norman Gray - Safety and quality issues
Inspector • Advantages of pre-filleds
MHRA - Time benefits/improved throughput
- Safety
11:00 Morning refreshments
- Hygeine
- Storage/inventory issues
11:20 End user compliance: implications, requirements
and opportunities • Training issues
• End user needs - Confidence and competence
• Aspects of compliance - Challenge of different learning styles
• Patient compliance studies
- Use of core trainers
• Market trends and health economics
• Summary • Flexibility
- Features that provide a safe/quality service in a dynamic environment
12:00 Advanced formulations of biologics • Wish list
• Degradation pathways of biologics - Features we would like in an ideal world!
• Interactions of biologics with containers and other components
Frank Ellwood
• Control of biologics stability by formulation
CT Superintendent
• Advanced formulations of biologics
Plymouth Hospitals NHS Trust
• Stable liquid formulations for prefilled syringes
• High concentration antibodies
16:00 Novel technology to offer an additional benefit to
Dr Jan Jezek
Chief Scientific Officer the customer
Arecor Matthew Young and Dr Catherine Beech
Chief Executive Officer, Director
12:40 Networking lunch Oval Medical Technologies
13:40 Approaches to ensure drug identity, potency and quality 16:40 Chair’s closing remarks
• Pre filled syringes as a delivery device and storage container
• Ensuring drug potency 16:50 End of conference
• Stability studies
• Drug safety
• Summary
Dr Wolfgang Papst
Device Development
Novartis

6. Registration Form
4th Pre-Filled Syringes
17th - 19th October 2011, London, UK
Angel
Conf. code Pentonville Road
4th Pre-Filled Syringes
Ci
Standard Prices
ty
Ro
ad
Conference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80
17th - 19th October 2011
Conference only Fee: £1299 VAT: £259.80 Total: £1558.80
Old Street
Workshop only Fee: £599 VAT: £119.80 Total: £718.80 Location: Visiongain Conference Centre
Old Street
Number of bookings: Total cost: Address:
230 City Road
London
City Road
EC1V 2TT
Promotional Literature Distribution UK
Distribution of your company’s promotional literature to all conference attendees
Fee: £999 VAT: £199.80 Total: £1198.80
How to book
Details
Email: piyush.patel@visiongain.com
Forename: Surname: Web: http://www.visiongain.com/syringes
UK Office:
Job Title: Company: Tel: +44(0) 20 7549 9961
Fax: +44(0) 20 7549 9932
Main Switchboard Number: Visiongain Ltd
230 City Road
London
Address: EC1V 2QY
UK
General information
Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United
Country: Postcode: Kingdom. Closest tube station is Old Street (Northern Line).
Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376
Phone: Fax: 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343
http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html
Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207
Email: 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain
Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may
be requested if payment has not been received in full before the event. Visiongain Ltd reserves the
I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices.
Substitutions/name changes or cancellations: There is a 50% liability on all bookings once
Methods of payment made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or
after one month before the start of the event. Should you decide to cancel after this date, the full invoice
Payment must be made in sterling must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places
between conferences. However, if you cannot attend the conference, you may make a substitution/name
By Mail: Complete and return your signed registration form together with your cheque payable change at any time, as long as we are informed in writing by email, fax or post. Name changes and
to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK substitutions must be from the same company or organisation and are not transferable between
countries. Please note that discounted delegates places at a visiongain event are non refundable.
By Fax: Complete and fax your signed registration form with your credit card details
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customer by credit card prior to the changes being made.
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due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try
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expenses, which may be incurred by the customer as a consequence of the event being postponed or
Visiongain Ltd A/C: visiongain Ltd
cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the
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Fee: The conference fee includes lunch, refreshments and conference papers provided on the day.
This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly
recommend you obtain).
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incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com.
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with your payment. You will receive speaker talks in PDFs two weeks after the event.
News updates Yes, please send me speaker talks Price£550 VAT:£110 Total:£660
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